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Proposed Rule

Semiannual Regulatory Agenda

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Start Preamble Start Printed Page 34052

AGENCY:

Office of the Secretary, HHS.

ACTION:

Semiannual regulatory agenda.

SUMMARY:

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-6827.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Department of Health and Human Services (HHS) is the Federal Government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

This Agenda presents the rulemaking activities that the Department expects to undertake in the foreseeable future to advance this mission. The Agenda furthers several Departmental goals, including strengthening health care; advancing scientific knowledge and innovation; advancing the health, safety, and well-being of the American people; increasing efficiency, transparency, and accountability of HHS programs; and strengthening the Nation's health and human services infrastructure and workforce.

HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process. The Department's Public Participation Task Force, which was created as part of the HHS Retrospective Review plan in response to Executive Order 13563 (Improving Regulation and Regulatory Review), regularly meets to identify ways to make the rulemaking process more accessible to the general public. For example, to encourage public participation, we regularly update our regulatory Web page (http://www.hhs.gov/​regulations), which includes links to HHS rules currently open for public comment, and provides a “regulations toolkit” with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations, including through a comment form on the HHS retrospective review Web page (http://www.HHS.gov/​RetrospectiveReview). In addition, a cross-agency team at HHS is currently considering how to increase efficiency in rulemaking by organizing public comment on proposed rules.

The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at http://www.reginfo.gov.

Start Signature

Dated: February 20, 2014.

Jennifer M. Cannistra,

Executive Secretary to the Department.

End Signature

Substance Abuse and Mental Health Services Administration—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
120SAMHSA User Fees for Publications0930-AA18

Food and Drug Administration—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
121Food Labeling; Revision of the Nutrition and Supplement Facts Labels0910-AF22
122Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs0910-AF23
123Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products0910-AF31
124Over-the-Counter (OTC) Drug Review—Internal Analgesic Products0910-AF36
125Over-the-Counter (OTC) Drug Review—Sunscreen Products0910-AF43
126Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products0910-AF69
127Abbreviated New Drug Applications and 505(b)(2)0910-AF97
128Updated Standards for Labeling of Pet Food0910-AG09
129Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals0910-AG10
130Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products0910-AG12
131Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products0910-AG18
132Produce Safety Regulation0910-AG35
133Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food0910-AG36
134“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-AG38
135Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives0910-AG59
136Foreign Supplier Verification Program0910-AG64
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137Format and Content of Reports Intended to Demonstrate Substantial Equivalence0910-AG96
138Sanitary Transportation of Human and Animal Food0910-AG98
139Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System0910-AH03
140Mammography Quality Standards Act; Regulatory Amendments0910-AH04
141Investigational New Drug Application Annual Reporting0910-AH07

Food and Drug Administration—Final Rule Stage

Sequence No.TitleRegulation Identifier No.
142Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling0910-AF11
143Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use0910-AF33
144Over-the-Counter (OTC) Drug Review—Laxative Drug Products0910-AF38
145Laser Products; Amendment to Performance Standard0910-AF87
146Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices0910-AG48
147Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56
148Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-AG57
149Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products0910-AG81
150Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94
151Veterinary Feed Directive0910-AG95

Food and Drug Administration—Long-Term Actions

Sequence No.TitleRegulation Identifier No.
152Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors0910-AF27
153Focused Mitigation Strategies To Protect Food Against Intentional Adulteration0910-AG63

Food and Drug Administration—Completed Actions

Sequence No.TitleRegulation Identifier No.
154Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Completion of a Section 610 Review)0910-AG14
155General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps0910-AG54
156Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids0910-AH13

Centers for Medicare & Medicaid Services—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
157Home Health Agency Conditions of Participation (CMS-3819-P) (Rulemaking Resulting From a Section 610 Review)0938-AG81
158Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) (Section 610 Review)0938-AS11
159CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Section 610 Review)0938-AS12
160CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P) (Section 610 Review)0938-AS15
161CY 2016 Notice of Benefit and Payment Parameters (CMS-9944-P) (Section 610 Review)0938-AS19
162Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review)0938-AS21
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Centers for Medicare & Medicaid Services—Final Rule Stage

Sequence No.TitleRegulation Identifier No.
163Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)0938-AQ41
164Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) (Section 610 Review)0938-AR62
165Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)0938-AS01
166Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) (Section 610 Review)0938-AS18

Centers for Medicare & Medicaid Services—Long-Term Actions

Sequence No.TitleRegulation Identifier No.
167Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F)0938-AO91

Centers for Medicare & Medicaid Services—Completed Actions

Sequence No.TitleRegulation Identifier No.
168CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F) (Completion of a Section 610 Review)0938-AR55
169Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-FC) (Completion of a Section 610 Review)0938-AR56
170CY 2015 Notice of Benefit and Payment Parameters (CMS-9954-F) (Completion of a Section 610 Review)0938-AR89

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Proposed Rule Stage

120. • SAMHSA User Fees for Publications

Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; EO 8284; EO 11541; Pub. L. 113-76

Abstract: SAMSHA is proposing to implement a modest cost recovery program to partially offset the high costs of distributing its materials to the public. This user fee would apply only to “over-the-limit” non-governmental orders. An “over the limit” order is defined as an order that exceeds either the average weight value (3.75 lbs) or the average number of copies (8). The “non-governmental orders” do not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA staff for meetings or conferences; and orders from “.gov” and “.mil” addresses. Therefore, it is assumed that SAMHSA would not charge shipping for orders by other Federal, State, and local government agencies. The proposed rule would implement recent legislation allowing the funds collected as part of a user fee for publications and data requests to be available to SAMHSA until expended.

Timetable:

ActionDateFR Cite
NPRM12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian Altman, Legislative Director, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 276-2009, Email: brian.altman@samhsa.gov.

RIN: 0930-AA18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

121. Food Labeling; Revision of the Nutrition and Supplement Facts Labels

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

Abstract: FDA is proposing to amend the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. If finalized, this rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label.

Timetable:

ActionDateFR Cite
ANPRM07/11/0368 FR 41507
ANPRM Comment Period End10/09/03
Second ANPRM04/04/0570 FR 17008
Second ANPRM Comment Period End06/20/05
Third ANPRM11/02/0772 FR 62149
Third ANPRM Comment Period End01/31/08
NPRM03/03/1479 FR 11879
NPRM Comment Period End06/02/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Start Printed Page 34055 Phone: 240 402-5429, Email: nutritionprogramstaff@fda.hhs.gov.

RIN: 0910-AF22

122. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Raccs

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

Abstract: FDA is proposing to amend its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. If finalized, this rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also considering amending the definition of single-serving containers; amending the definition of serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or units, as applicable, under certain circumstances.

Timetable:

ActionDateFR Cite
ANPRM04/04/0570 FR 17010
ANPRM Comment Period End06/20/05
NPRM03/03/1479 FR 11989
NPRM Comment Period End06/02/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Cherisa Henderson, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax: 301 436-1191, Email: nutritionprogram staff@fda.hhs.gov.

RIN: 0910-AF23

123. Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements.

Timetable:

ActionDateFR Cite
Reopening of Administrative Record08/25/0065 FR 51780
Comment Period End11/24/00
NPRM (Amendment) (Common Cold)09/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF31

124. Over-the-Counter (OTC) Drug Review—Internal Analgesic Products

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products.

Timetable:

ActionDateFR Cite
NPRM (Amendment) (Required Warnings and Other Labeling)12/26/0671 FR 77314
NPRM Comment Period End05/25/07
Final Action (Required Warnings and Other Labeling)04/29/0974 FR 19385
Final Action (Correction)06/30/0974 FR 31177
Final Action (Technical Amendment)11/25/0974 FR 61512
NPRM (Amendment) (Pediatric)12/00/14
NPRM (Amendment) (Acetaminophen)12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF36

125. Over-the-Counter (OTC) Drug Review—Sunscreen Products

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first of the future actions will address the safety of sunscreen active ingredients.

Timetable:

ActionDateFR Cite
ANPRM (Sunscreen and Insect Repellent)02/22/0772 FR 7941
ANPRM Comment Period End05/23/07
NPRM (UVA/UVB)08/27/0772 FR 49070
NPRM Comment Period End12/26/07
Final Action (UVA/UVB)06/17/1176 FR 35620
NPRM (Effectiveness)06/17/1176 FR 35672
NPRM (Effectiveness) Comment Period End09/15/11
ANPRM (Dosage Forms)06/17/1176 FR 35669
ANPRM (Dosage Forms) Comment Period End09/15/11
Proposed Rule03/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Start Printed Page 34056Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF43

126. Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antimicrobial agents in healthcare antiseptic products.

Timetable:

ActionDateFR Cite
NPRM (Healthcare)06/17/9459 FR 31402
Comment Period End12/15/95
NPRM (Consumer Hand Wash Products)12/17/1378 FR 76443
NPRM (Healthcare Antiseptic)03/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF69

127. Abbreviated New Drug Applications and 505(B)(2)

Legal Authority: Pub. L. 108-173, title XI; 21 U.S.C. 355; 21 U.S.C. 371

Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and related applications to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications.

Timetable:

ActionDateFR Cite
NPRM05/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AF97

128. Updated Standards for Labeling of Pet Food

Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 1002(a)(3)

Abstract: FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and useful information about the nutrient content and ingredient composition of pet food products.

Timetable:

ActionDateFR Cite
NPRM10/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email: william.burkholder@fda.hhs.gov.

RIN: 0910-AG09

129. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271; . . .

Abstract: This rule establishes requirements for good manufacturing practice, and to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food marketed for all animals, including pets, is safe.

Timetable:

ActionDateFR Cite
NPRM10/29/1378 FR 64736
NPRM Comment Period Extension02/03/1479 FR 6111
NPRM Comment Period End02/26/14
NPRM Comment Period Extension End03/31/14
Supplemental NPRM07/00/14
Final Rule08/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: kim.young@fda.hhs.gov.

RIN: 0910-AG10

130. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products.

Timetable:

ActionDateFR Cite
NPRM12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 Start Printed Page 34057796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AG12

131. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Megan Velez, Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9301, Email: megan.velez@fda.hhs.gov.

RIN: 0910-AG18

132. Produce Safety Regulation

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)

Abstract: This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3503
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24692
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48637
NPRM Comment Period Extended End11/15/13
Notice of Intent To Prepare an Enviromental Impact Statement for the Proposed Rule08/19/1378 FR 50358
Notice of Intent To Prepare Enviromental Impact Statement for the Proposed Rule Comment Period End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69605
NPRM Comment Period Extended End11/22/13
Environmental Impact Statement for the Proposed Rule; Comment Period Extended11/18/1378 FR 69006
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End03/14/14
Supplemental NPRM07/00/14
Final Rule10/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AG35

133. Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

Abstract: This rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3646
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24691
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48636
NPRM Comment Period Extended End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69604
NPRM Comment Period Extended End11/22/13
Supplemental NPRM07/00/14
Final Rule08/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Jenny Scott, Senior Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1488, Email: jenny.scott@fda.hhs.gov.

RIN: 0910-AG36

134. “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco Control Act

Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of “tobacco Start Printed Page 34058product” to be subject to the FD&C Act, and would specify additional restrictions.

Timetable:

ActionDateFR Cite
NPRM04/25/1479 FR 23142
NPRM Comment Period End07/09/14
Final Action06/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: may.nelson@fda.hhs.gov.

RIN: 0910-AG38

135. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives

Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family Smoking Prevention and Tobacco Control Act

Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the agency determines should be tested to protect the public health.

Timetable:

ActionDateFR Cite
NPRM11/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Room 240 H, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: carol.drew@fda.hhs.gov.

RIN: 0910-AG59

136. Foreign Supplier Verification Program

Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Abstract: This rule describes what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45729
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69602
NPRM Comment Period Extended End01/27/14
Supplemental NPRM07/00/14
Final Rule10/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: brian.pendleton@fda.hhs.gov.

RIN: 0910-AG64

137. Format and Content of Reports Intended To Demonstrate Substantial Equivalence

Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act

Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence and compliance with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This regulation also would provide information as to how the Agency will review and act on these submissions.

Timetable:

ActionDateFR Cite
NPRM02/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, Email: gerie.voss@fda.hhs.gov.

RIN: 0910-AG96

138. Sanitary Transportation of Human and Animal Food

Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 371; . . .

Abstract: This rule would establish requirements for shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated.

Timetable:

ActionDateFR Cite
ANPRM04/30/1075 FR 22713
ANPRM Comment Period End08/30/10
NPRM02/05/1479 FR 7005
NPRM Comment Period End05/31/14
Final Rule03/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2022, Fax: 301 346-2632, Email: michael.kashtock@fda.hhs.gov.

RIN: 0910-AG98

139. Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Legal Authority: 21 U.S.C. 360c

Abstract: The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X-ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which, when combined with the general controls, would provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.Start Printed Page 34059

Timetable:

ActionDateFR Cite
NPRM12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Erica Blake, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: erica.blake@fda.hhs.gov.

RIN: 0910-AH03

140. Mammography Quality Standards Act; Regulatory Amendments

Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b

Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes, such as breast density reporting, that have occurred since the regulations were published in 1997.

Timetable:

ActionDateFR Cite
NPRM12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AH04

141. • Investigational New Drug Application Annual Reporting

Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(a)

Abstract: This proposed rule would revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Timetable:

ActionDateFR Cite
NPRM03/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Peter A. Taschenberger, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD 20993, Phone: 301 796-0018, Fax: 301 847-3529, Email: peter.taschenberger@fda.hhs.gov.

RIN: 0910-AH07

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

142. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: This final rule will amend the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of regulations regarding the labeling for human prescription drug and biological products to better communicate risks.

Timetable:

ActionDateFR Cite
NPRM05/29/0873 FR 30831
NPRM Comment Period End08/27/08
Final Action07/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Molly Flannery, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3543, Email: molly.flannery@fda.hhs.gov.

RIN: 0910-AF11

143. Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant.

Timetable:

ActionDateFR Cite
NPRM (Amendment)07/13/0570 FR 40232
NPRM Comment Period End11/10/05
Final Action (Technical Amendment)03/19/0772 FR 12730
Final Action (Oral Bronchodilator and Oral Nasal Decongestant)12/00/14
Final Action (Oral Bronchodilator and Expectorant)12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF33

144. Over-the-Counter (OTC) Drug Review—Laxative Drug Products

Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360 to 360a; 21 U.S.C. 371 to 371a

Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the Start Printed Page 34060monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products.

Timetable:

ActionDateFR Cite
Final Action (Granular Psyllium)03/29/0772 FR 14669
NPRM (Professional Labeling—Sodium Phosphate)02/11/1176 FR 7743
NPRM Comment Period End03/14/11
Final Action (Professional Labeling—Sodium Phosphate)12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF38

145. Laser Products; Amendment to Performance Standard

Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393

Abstract: The regulation will amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology.

Timetable:

ActionDateFR Cite
NPRM06/24/1378 FR 37723
NPRM Comment Period End09/23/13
Final Action12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AF87

146. Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .

Abstract: This rule will amend FDA's regulations on acceptance of data from clinical studies for medical devices to require that clinical studies conducted outside the United States in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission be conducted in accordance with good clinical practice.

Timetable:

ActionDateFR Cite
NPRM02/25/1378 FR 12664
NPRM Comment Period End05/28/13
Final Action12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational Device Exemptions Staff, Department of Health and Human Services, Food and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: sheila.brown@fda.hhs.gov.

RIN: 0910-AG48

147. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

Abstract: FDA published a proposed rule to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19238
NPRM Comment Period End07/05/11
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG56

148. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

Abstract: FDA published a proposed rule in the Federal Register to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19192
NPRM Comment Period End07/05/11
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG57

149. Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31

Abstract: This rule will require manufacturers and importers of tobacco products to submit certain market share data to FDA. USDA currently collects such data, but its program sunsets at the end of September 2014, and USDA will cease collection of this information. FDA is taking this action so that it may Start Printed Page 34061continue to calculate market share percentages needed to compute user fees.

Timetable:

ActionDateFR Cite
NPRM05/31/1378 FR 32581
NPRM Comment Period End08/14/13
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Room 340K, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: annette.marthaler@fda.hhs.gov.

RIN: 0910-AG81

150. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .

Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change. This rule would describe the process by which information regarding “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change.

Timetable:

ActionDateFR Cite
NPRM11/13/1378 FR 67985
NPRM Comment Period End01/13/14
Final Rule12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AG94

151. Veterinary Feed Directive

Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1; 21 U.S.C. 371

Abstract: The Animal Drug Availability Act created a new category of products called veterinary feed directive (VFD) drug. This rulemaking is intended to provide for the increased efficiency of the VFD program.

Timetable:

ActionDateFR Cite
ANPRM03/29/1075 FR 15387
ANPRM Comment Period End06/28/10
NPRM12/12/1378 FR 75515
NPRM Comment Period End03/12/14
Final Rule04/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sharon Benz, Supervisory Animal Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7529 Standish Place, Rockville, MD 20855, Phone: 240 453-6864, Email: sharon.benz@fda.hhs.gov.

RIN: 0910-AG95

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

152. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21 U.S.C. 371

Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.

Timetable:

X

ActionDateFR Cite
NPRM07/09/9661 FR 36154
NPRM Comment Period End12/06/96
NPRM Comment Period Reopened04/28/0368 FR 22341
NPRM Comment Period Extended06/27/0368 FR 38247
NPRM Comment Period End08/26/03
NPRM Comment Period Reopened08/01/0671 FR 43392
NPRM Comment Period End09/15/06
Interim Final Rule02/10/1479 FR 7934
Interim Final Rule Comment Period End03/27/14
Final Rule07/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Benson Silverman, Staff Director, Infant Formula and Medical Foods, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1459, Email: benson.silverman@fda.hhs.gov.

RIN: 0910-AF27

153. Focused Mitigation Strategies To Protect Food Against Intentional Adulteration

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111—353

Abstract: This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

Timetable:

ActionDateFR Cite
NPRM12/24/1378 FR 78014
NPRM Comment Period End03/31/14
Final Rule05/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Jody Menikheim, Supervisory General Health Scientist, Department of Health and Human Services, Food and Drug Start Printed Page 34062Administration, Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864, Fax: 301 436-2633, Email: fooddefense@fda.hhs.gov.

RIN: 0910-AG63

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

154. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Completion of a Section 610 Review)

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381

Abstract: FDA has completed their review of the regulations promulgated under the Prescription Drug Marketing Act. The review was done to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities.

Timetable:

ActionDateFR Cite
Begin Review of Current Regulation11/24/08
End Review of Current Regulation11/29/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: pdma610(c)review@fda.hhs.gov.

RIN: 0910-AG14

155. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps

Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360j; 21 U.S.C. 371

Abstract: FDA is proposing to amend the classification of infusion pumps from class II (performance standards) to class II (special controls). FDA is taking this action to provide reasonable assurance of the safety and effectiveness of these devices.

Timetable:

ActionDateFR Cite
Withdrawn04/24/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AG54

156. • Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371

Abstract: The final rule addresses the nutrient content claims for docosahexaenoic acid and eicosapentaenoic acid set forth in notifications submitted by (1) Alaska General Seafoods, Ocean Beauty Seafoods Inc., and Trans-Ocean Products Inc. (the seafood processors notification), (2) Martek Biosciences Corp. (the Martek notification), and (3) Ocean Nutrition Canada Ltd. The final rule also addresses the nutrient content claims for alpha-linolenic acid set forth in the seafood processors notification and the Martek notification.

Timetable:

ActionDateFR Cite
NPRM11/27/0772 FR 66103
NPRM Comment Period End02/11/08
Final Action04/28/1479 FR 23262

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301 436-1191, Email: vincent.dejesus@fda.hhs.gov.

RIN: 0910-AH13

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

157. Home Health Agency Conditions of Participation (CMS-3819-P) (Rulemaking Resulting From a Section 610 Review)

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb

Abstract: This proposed rule would revise the existing Conditions of Participation that Home Health Agencies must meet to participate in the Medicare program. The new requirements would focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to improve patient safety and achieve broad-based improvements in the quality of care furnished through Federal programs, while at the same time reducing procedural burdens on providers.

Timetable:

ActionDateFR Cite
NPRM03/10/9762 FR 11005
NPRM Comment Period End06/09/97
Second NPRM05/00/14

Regulatory Flexibility Analysis Required: No.

Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, Email: danielle.shearer@cms.hhs.gov.

RIN: 0938-AG81

158. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) (Section 610 Review)

Legal Authority: sec 1886(d) of the Social Security Act

Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.Start Printed Page 34063

Timetable:

ActionDateFR Cite
NPRM05/14/1479 FR 27977
NPRM Comment Period End06/30/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian Slater, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6229, Email: brian.slater@cms.hhs.gov.

RIN: 0938-AS11

159. CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Section 610 Review)

Legal Authority: Social Security Act, secs 1102, 1871 and 1848

Abstract: This annual proposed rule would revise payment policies under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2015.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov.

RIN: 0938-AS12

160. CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P) (Section 610 Review)

Legal Authority: Sec 1833 of the Social Security Act

Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system (PPS) to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the ambulatory surgical center payment system list of services and rates.

Timetable:

ActionDateFR Cite
NPRM07/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mail Stop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AS15

161. • CY 2016 Notice of Benefit and Payment Parameters (CMS-9944-P) (Section 610 Review)

Legal Authority: Pub. L. 111-148,title I

Abstract: This proposed rule would establish the CY 2016 payment parameters for the cost-sharing reductions, advance payments of the premium tax credit, reinsurance, and risk adjustment programs as required by the Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM11/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sharon Arnold, Director, Payment Policy and Financial Management Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email: sharon.arnold@cms.hhs.gov.

RIN: 0938-AS19

162. • Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review)

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr

Abstract: This proposed rule would revise the requirements that hospitals and CAHs must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect substantial advances in healthcare delivery and in patient safety knowledge and practices, and would allow hospitals and CAHs the flexibility to implement innovative patient care practices. The changes are also an integral part of our efforts to achieve broad-based improvements in patient safety and in the quality of health care furnished through Federal programs.

Timetable:

ActionDateFR Cite
NPRM09/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: CDR Scott Cooper, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9465, Email: scott.cooper@cms.hhs.gov.

RIN: 0938-AS21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

163. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)

Legal Authority: Pub. L. 111-48, secs 2501, 2503, 3301(d)(2); Pub. L. 111-152, sec 1206; Pub. L. 111-8, sec 221

Abstract: This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.

Timetable:

ActionDateFR Cite
NPRM02/02/1277 FR 5318
NPRM Comment Period End04/02/12
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Wendy Tuttle, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-8690, Email: wendy.tuttle@cms.hhs.gov.Start Printed Page 34064

RIN: 0938-AQ41

164. Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) (Section 610 Review)

Legal Authority: Pub. L. 111-148, sec 10501

Abstract: This final rule establishes methodology and payment rates for a prospective payment system (PPS) for Federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This rule also establishes a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this rule makes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.

Timetable:

ActionDateFR Cite
NPRM09/23/1378 FR 58386
NPRM Comment Period End11/18/13
Final Rule05/02/1479 FR 25436
Final Rule With Comment Period End07/01/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5620, Email: corinne.axelrod@cms.hhs.gov.

RIN: 0938-AR62

165. Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)

Legal Authority: Pub. L. 104-191, sec 1104

Abstract: Under the Affordable Care Act, this interim final rule adopts operating rules for HIPAA transactions for health care claims or equivalent encounter information, enrollment and disenrollment of a health plan, health plan premium payments, and referral certification and authorization.

Timetable:

ActionDateFR Cite
Interim Final Rule03/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Geanelle Herring, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Administrative Simplification Group, Office of E-Health Standards and Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4466, Email: geanelle.herring@cms.hhs.gov.

RIN: 0938-AS01

166. • Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) (Section 610 Review)

Legal Authority: Pub. L. 113-67, secs 1105 and 1106

Abstract: This interim final rule implements changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital program under the hospital inpatient prospective payment systems for FY 2014 (through March 31, 2014) in accordance with sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act of 2013.

Timetable:

ActionDateFR Cite
Interim Final Rule03/18/1479 FR 15022
Interim Final Rule Comment Period End05/12/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Michele Hudson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-10-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5490, Email: michele.hudson@cms.hhs.gov.

RIN: 0938-AS18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

167. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F)

Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861ff (3)(B)(i)(ii); 42 U.S.C. 1913(c)(1) et al

Abstract: This rule finalizes emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters and coordinate with Federal, State, tribal, regional, and local emergency preparedness systems. This rule ensures providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.

Timetable:

ActionDateFR Cite
NPRM12/27/1378 FR 79082
NPRM Comment Period Extended02/21/1479 FR 9872
NPRM Comment Period End03/31/14
Final Action12/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Graham, Health Insurance Specialist,, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email: janice.graham@cms.hhs.gov.

RIN: 0938-AO91

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

168. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F) (Completion of a Section 610 Review)

Legal Authority: MIPPA; sec 153(b); Pub. L. 111-148; sec 3401(h); ATRA; sec 632(a)Start Printed Page 34065

Abstract: This final rule updates the bundled payment system for End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also updates the Quality Incentives in the ESRD Program. In addition, this rule clarifies the grandfathering provision related to the 3-year minimum lifetime requirement for Durable Medical Equipment (DME). It also provides clarification of the definition of routinely purchased DME.

Timetable:

ActionDateFR Cite
NPRM07/08/1378 FR 40835
NPRM Comment Period End08/30/13
Final Action12/02/1378 FR 72156

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Michelle Cruse, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-7540, Email: michelle.cruse@cms.hhs.gov.

RIN: 0938-AR55

169. Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-FC) (Completion of a Section 610 Review)

Legal Authority: Social Security Act, secs 1102, 1871, 1848

Abstract: This final rule revises payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes are applicable to services furnished on or after January 1, annually.

Timetable:

ActionDateFR Cite
NPRM07/19/1378 FR 43282
NPRM Comment Period End09/06/13
Final Action12/10/1378 FR 74230

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov.

RIN: 0938-AR56

170. CY 2015 Notice of Benefit and Payment Parameters (CMS-9954-F) (Completion of a Section 610 Review)

Legal Authority: Pub. L. 111-148

Abstract: This final rule establishes the CY 2015 payment parameters for the cost-sharing reductions, advance premium tax credit, reinsurance, and risk adjustment programs as required by the Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM12/02/1378 FR 72322
NPRM Comment Period End12/26/13
Final Action03/11/1479 FR 13743
Final Action Effective05/12/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sharon Arnold, Director, Payment Policy and Financial Management Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email: sharon.arnold@cms.hhs.gov.

RIN: 0938-AR89

End Supplemental Information

[FR Doc. 2014-13125 Filed 6-12-14; 8:45 am]

BILLING CODE 4150-24-P