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Rule
Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments
A Rule by the Food and Drug Administration on 06/01/2011
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 06/01/2011
- Agencies:
- Food and Drug Administration
- Dates:
- This rule is effective June 1, 2011.
- Effective Date:
- 06/01/2011
- Document Type:
- Rule
- Document Citation:
- 76 FR 31468
- Page:
- 31468-31470 (3 pages)
- CFR:
- 21 CFR 5
- 21 CFR 10
- 21 CFR 14
- 21 CFR 19
- 21 CFR 20
- 21 CFR 21
- 21 CFR 314
- 21 CFR 350
- 21 CFR 516
- 21 CFR 814
- Agency/Docket Number:
- Docket No. FDA-2011-N-0318
- Document Number:
- 2011-13488
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- 149
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- Docket Number:
- FDA-2011-N-0318
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- AGENCY:
- ACTION:
- SUMMARY:
- DATES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- List of Subjects
- 21 CFR Part 5
- 21 CFR Part 10
- 21 CFR Part 14
- 21 CFR Part 19
- 21 CFR Part 20
- 21 CFR Part 21
- 21 CFR Part 314
- 21 CFR Part 350
- 21 CFR Part 516
- 21 CFR Part 814
- PART 5—ORGANIZATION
- PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES
- PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
- PART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
- PART 20—PUBLIC INFORMATION
- PART 21—PROTECTION OF PRIVACY
- PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
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Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
DATES:
This rule is effective June 1, 2011.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Fred Sadler, Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 301-796-8975.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
FDA is making technical amendments in the Agency's regulations under 21 CFR parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 as a result of a recent office move. The former address, telephone number, and fax number was: rm. 6-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, telephone: 301-827-6567, FAX: 301-443-1726. The new address is: Division of Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, telephone: 301-796-3900, FAX: 301-796-9267. The Division of Freedom of Information Public Reading Room number is 1050.
Publication of this document constitutes final action of these changes under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors.
Start List of SubjectsList of Subjects
- Authority delegations (Government agencies)
- Imports
- Organization and functions (Government agencies)
- Administrative practice and procedure
- Advisory committees
- Color additives
- Drugs
- Radiation protection
- Administrative practice and procedure
- Confidential business information
- Drugs
- Reporting and recordkeeping requirements
- Administrative practice and procedure
- Animal drugs
- Confidential business information
- Reporting and recordkeeping requirements
- Administrative practice and procedure
- Confidential business information
- Medical devices
- Medical research
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 are amended as follows:
Start PartPART 5—ORGANIZATION
End Part Start Amendment Part1. The authority citation for
End Amendment Part Start AuthorityAuthority: 5 U.S.C. 552; 21 U.S.C. 301-397.
End Authority Start Amendment Part2. Revise § 5.1110(b) to read as follows:
End Amendment Part(b) Division of Freedom of Information. The Division of Freedom of Information Public Reading Room is located in rm. 1050, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; Telephone: 301-796-3900.
PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES
End Part Start Amendment Part3. The authority citation for
End Amendment Part Start AuthorityAuthority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
End Authority4. In § 10.85(d)(4), remove “Freedom of Information Staff (HFI-35)” and in its place add “Division of Freedom of Information (ELEM-1029)”.
End Amendment Part5. In § 10.90(d), remove “Freedom of Information Staff (HFI-35),” and in its place add “Division of Freedom of Information (ELEM-1029)”.
End Amendment Part6. In § 10.95, remove “Freedom of Information Staff” and “Freedom of Information Staff (HFI-35)” everywhere they appear and in their places add “Division of Freedom of Information (ELEM-1029)”.
End Amendment Part Start PartPART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
End Part Start Amendment Part7. The authority citation for
End Amendment Part Start AuthorityAuthority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.
End Authority8. In § 14.65(c), remove “Freedom of Information Staff (HFI-35)” and in its place add “Division of Freedom of Information (ELEM-1029)”.
End Amendment Part Start PartPART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
End Part Start Amendment Part9. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 371.
End Authority10. In § 19.10(d) introductory text, remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”.
End Amendment Part Start PartPART 20—PUBLIC INFORMATION
End Part Start Amendment Part11. The authority citation for
End Amendment Part Start AuthorityAuthority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
End Authority Start Amendment Part12. Revise § 20.3(b) to read as follows:
End Amendment Part(b) A request for certified copies of records or for authentication of records shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
13. Revise § 20.26(b), to read as follows:
End Amendment Part(b) Each such index will be made available through the Internet at http://www.fda.gov. A printed copy of each index is available by writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, at the same address.
14. Revise § 20.30 to read as follows:
End Amendment Part(a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
(b) All requests for Agency records shall be sent in writing to this office.
15. In § 20.40, revise paragraph (a); and in paragraph (c), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information” to read as follows:
End Amendment Part(a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; or by faxing it to 301-796-9267. All requests must contain the postal address and telephone number of the requester and the name of the person responsible for payment of any fees that may be charged.
16. In § 20.41 paragraph (a), paragraph (b) introductory text, and paragraph (c), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”.
End Amendment Part17. In § 20.44(e), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”.
End Amendment Part Start Amendment Part18. In § 20.107(a), revise the second sentence to read as follows:
End Amendment Part(a) * * * An index of all such manuals is available by writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; or by visiting the Division of Freedom of Information Public Reading Room, Start Printed Page 31470located in rm. 1050, at the same address. * * *
19. In § 20.108, remove “Freedom of Information Public Room” everywhere it appears and in its place add “Division of Freedom of Information Public Reading Room”.
End Amendment Part Start Amendment Part20. In § 20.120, revise paragraph (a); paragraph (b) introductory text; and paragraph (b)(4) to read as follows:
End Amendment Part(a) The Food and Drug Administration operates two public reading rooms. The Division of Freedom of Information Public Reading Room is located in rm. 1050, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; the telephone number is 301-796-3900. The Division of Dockets Management Public Reading Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852; the telephone number is 301-827-6860. Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays.
(b) The following records are available at the Division of Freedom of Information Public Reading Room:
(4) Indexes of records maintained in the Division of Freedom of Information Public Reading Room; and
PART 21—PROTECTION OF PRIVACY
End Part Start Amendment Part21. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
End Authority22. In 21.32(b)(2), remove “(HFI-30)” and in its place add “(ELEM-1029)”.
End Amendment Part23. In § 21.40(b), remove “(HFI-30), Food and Drug Administration, 5600 Fishers Lane,” and in its place add “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”.
End Amendment Part24. In § 21.41, remove “Freedom of Information Staff” everywhere it appears and in its place add “Division of Freedom of Information (ELEM-1029)”; and remove “(HFI-30)” everywhere it appears.
End Amendment Part25. In § 21.43(a)(2), remove “Freedom of Information Staff public room” and in its place add “Division of Freedom of Information Public Reading Room”.
End Amendment Part Start PartPART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
End Part Start Amendment Part26. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.
End Authority Start Amendment Part27. In § 314.53(e), revise the last two sentences to read as follows:
End Amendment Part(e) * * * Patent information received by the Agency between monthly publication of supplements to the list will be placed on public display in FDA's Division of Freedom of Information. A request for copies of the file shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
End Part Start Amendment Part28. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
End Authority29. In § 350.60, in the last sentence, remove “FOI Staff (HFI-35), 5600 Fishers Lane, rm. 12A-16,” and in its place add “Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”.
End Amendment Part Start PartPART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
End Part Start Amendment Part30. The authority citation for part 516 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
End Authority31. In § 516.157(a), remove “Freedom of Information Staff or by visiting the FDA Freedom of Information Public Reading Room” and in its place add “Division of Freedom of Information or by visiting FDA's Division of Freedom of Information Public Reading Room”.
End Amendment Part Start PartPART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
End Part Start Amendment Part32. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.
End Authority33. In § 814.45(d)(2), remove “Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane,” and in its place add “Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”.
End Amendment Part Start SignatureDated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13488 Filed 5-31-11; 8:45 am]
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