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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

DATES:

Fax written comments on the collection of information by March 22, 2013.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0322. Also include the FDA docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Environmental Impact Considerations—(OMB Control Number 0910-0322)—Revision

FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.”

The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4327) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(c) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.

FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in significant environmental impact. Sections 25.40(a) and (c) specifies the content requirements for EAs for nonexcluded actions.

This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statues for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register document also filed for comment at the Environmental Protection Agency. The final EIS, including the comments received, is reviewed by the Agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.

Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.

In the Federal Register of September 28, 2012 (77 FR 59619), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two comments that were PRA related were received from one commenter.

(Comment 1) The commenter indicated that FDA underestimates the hours required to complete an environmental assessment for tobacco products, and that FDA's 12 hours burden estimate per response is substantially underestimated. The commenter said, based on the commenter's experience, an environmental assessment for tobacco products should take approximately 80 hours to complete.

(Response 1) FDA agrees with this comment. Upon further review of the number of hours required to complete an environmental assessment for tobacco products, FDA has determined that 12 hours is too low an estimate and has revised the burden estimate per response for completing an environmental assessment for tobacco products from 12 to 80 hours. This revision was based upon revisiting this estimate with the Center for Tobacco Products staff and this comment. Rethinking the time to prepare an environmental assessment for tobacco products resulted in revising the burden per response to 80 hours.

(Comment 2) The commenter also encouraged the Agency to establish categorical exclusions for environmental assessments for tobacco product submittals under section 905(j) of the Start Printed Page 11893Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387e(j)).

(Response 2) FDA has decided to not establish categorical exclusions for tobacco products at this time.

FDA estimates the burden of this collection of information as follows:

Estimated Annual Reporting Burden for Human Drugs (Including Biologics in the Center for Drug Evaluation and Research)

Under 21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 2011, FDA received 2,818 INDs from 2,064 sponsors, 99 NDAs from 79 applicants, 3,247 supplements to NDAs from 376 applicants, 5 biologic license applications (BLAs) from 5 applicants, 287 supplements to BLAs from 50 applicants, 895 ANDAs from 195 applicants, and 5,348 supplements to ANDAs from 299 applicants. FDA estimates that it will receive approximately 15,699 claims for categorical exclusions as required under § 25.15(a) and (d), and 10 EAs as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 3,175 respondents will submit an average of 4 applications for categorical exclusion and 10 respondents will submit an average of 1 EA. Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA.

Table 1—Estimated Annual Reporting Burden for Human Drugs 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)3,175412,7008101,600
25.40(a) and (c)101103,40034,000
Total135,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Human Foods

Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests from exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance must contain either a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. In 2011, FDA received 97 industry submissions. FDA received an annual average of 42 claims of categorical exclusions as required under § 25.15(a) and (d), and 33 EAs as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 42 respondents will submit an average of 1 application for categorical exclusion and 33 respondents will submit an average of 1 EA. FDA estimates that, on average, it takes petitioners, notifiers, or requestors approximately 3 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.

Table 2—Estimated Annual Reporting Burden for Human Foods 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)421428336
25.40(a) and (c)331332106,930
Total7,266
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Medical Devices

Under 21 CFR 814.20(b)(11), premarket approvals (PMA) (original PMAs and supplements) must contain a claim for categorical exclusion under § 25.30 or § 25.34 or an EA under § 25.40. In 2011, FDA received approximately 52 claims (original PMAs and supplements) for categorical exclusions as required under § 25.15(a) and (d), and 0 EAs as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 52 respondents will submit an average of 1 application for categorical exclusion. Based on information provided by less than 10 sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion.

Table 3—Estimated Annual Reporting Burden for Medical Devices 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)521526312
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Estimated Annual Reporting Burden for Biological Products, Drugs, and Medical Devices in the Center for Biologics Evaluation and Research

BLAs under 21 CFR 601.2(a), as well as INDs (§ 312.23), NDAs (§ 314.50), ANDAs (§ 314.94), and PMAs (§ 814.20), must contain either a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. In 2011, FDA received 14 BLAs from 14 applicants, and 831 BLA supplements to license applications from 153 applicants, 288 INDs from 210 sponsors, 1 NDA from 1 applicant, 37 supplements to NDAs from 9 applicants, 1 ANDA from 1 applicant, 12 supplements to ANDAs from 2 applicants, and 45 PMA supplements from 11 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.

FDA estimates that it received approximately 481 claims for categorical exclusion as required under § 25.15(a) and (d), and 2 EAs as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 247 respondents will submit an average of 2 applications for categorical exclusion and 2 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product.

Table 4—Estimated Annual Reporting Burden for Biological Products 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)247249483,952
25.40(a) and (c)2123,4006,800
Total10,752
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Animal Drugs

Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs), 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs, 21 CFR 511.1(b)(10) investigational new animal drug applications (INADs), and 21 CFR 571.1(c), food additive petitions must contain a claim for categorical exclusion under § 25.30 or § 25.33 or an EA under 25.40. In 2011, FDA's Center for Veterinary Medicine has received approximately 698 claims for categorical exclusion as required under § 25.15(a) and (d), and 10 EAs as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 70 respondents will submit an average of 10 applications for categorical exclusion and 10 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA.

Table 5—Estimated Annual Reporting Burden for Animal Drugs 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)701070032,100
25.40(a) and (c)101102,16021,600
Total23,700
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Tobacco Products

Under sections 905, 910, and 911 of the FD&C Act (21 U.S.C. 387j and 387k), premarket tobacco applications (PMTAs), applications for substantial equivalence (SEs), Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion under § 25.30 or § 25.34 or an EA under § 25.40. When estimating the burden for tobacco products, FDA considered the environmental impacts associated with different applications. Specifically, in 2011, FDA estimated it will receive approximately 20 PMTAs and supplements from 20 respondents, 150 reports intended to demonstrate the SE of a new tobacco product from 150 respondents, 500 exemptions from SE requirements applications from 500 respondents, and 3 modified risk tobacco product applications from 3 respondents. FDA is also not accepting claims for categorical exclusions at this time, and estimates that there will be 135 EAs from 135 respondents as required under § 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 135 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE., exemption from SE, or modified risk tobacco product application. Based on FDA's experience, previous information provided by potential sponsors, information provided by a commenter to this collection of information, and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA.Start Printed Page 11895

Table 6—Estimated Annual Reporting Burden for Tobacco Products 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.40(a) and (c)13511358010,800
Total10,800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 7—Estimated Annual Total Reporting Burden for All Centers 1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
25.15(a) and (d)3,58613,998108,300
25.40(a) and (c)19019080,130
Total188,430
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: February 14, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-03836 Filed 2-19-13; 8:45 am]

BILLING CODE 4160-01-P