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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:
PDF
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 10
21 CFR 14
21 CFR 19
21 CFR 20
21 CFR 21
21 CFR 314
21 CFR 350
21 CFR 516
21 CFR 5
21 CFR 814
Agency/Docket Number:
Docket No. FDA-2011-N-0318
Document Number:
2011-13488
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Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Docket Number:
FDA-2011-N-0318
Enhanced Content
Published Document

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Start Preamble

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 Info

FOR 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 Information

SUPPLEMENTARY 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 Subjects

List of Subjects

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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:

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PART 5—ORGANIZATION

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1. The authority citation for

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Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.

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2. Revise § 5.1110(b) to read as follows:

End Amendment Part
FDA public information offices.
* * * * *

(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.

* * * * *
Start Part

PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES

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3. The authority citation for

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Authority: 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.

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[Amended]
Start Amendment Part

4. In § 10.85(d)(4), remove “Freedom of Information Staff (HFI-35)” and in its place add “Division of Freedom of Information (ELEM-1029)”.

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[Amended]
Start Amendment Part

5. In § 10.90(d), remove “Freedom of Information Staff (HFI-35),” and in its place add “Division of Freedom of Information (ELEM-1029)”.

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[Amended]
Start Amendment Part

6. 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 Part

PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

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7. The authority citation for

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Authority: 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.

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[Amended]
Start Amendment Part

8. 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 Part

PART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

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9. The authority citation for

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Authority: 21 U.S.C. 371.

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[Amended]
Start Amendment Part

10. 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 Part

PART 20—PUBLIC INFORMATION

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11. The authority citation for

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Authority: 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.

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12. Revise § 20.3(b) to read as follows:

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Certification and authentication of Food and Drug Administration records.
* * * * *

(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.

Start Amendment Part

13. Revise § 20.26(b), to read as follows:

End Amendment Part
Indexes of certain records.
* * * * *

(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.

Start Amendment Part

14. Revise § 20.30 to read as follows:

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Food and Drug Administration Division of Freedom of Information.

(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.

Start Amendment Part

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
Filing a request for records.

(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.

* * * * *
[Amended]
Start Amendment Part

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 Part
[Amended]
Start Amendment Part

17. In § 20.44(e), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”.

End Amendment Part Start Amendment Part

18. In § 20.107(a), revise the second sentence to read as follows:

End Amendment Part
Food and Drug Administration manuals.

(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. * * *

* * * * *
Start Amendment Part

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 Part

20. In § 20.120, revise paragraph (a); paragraph (b) introductory text; and paragraph (b)(4) to read as follows:

End Amendment Part
Records available in Food and Drug Administration Public Reading Rooms.

(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

* * * * *
Start Part

PART 21—PROTECTION OF PRIVACY

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21. The authority citation for

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Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.

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[Amended]
Start Amendment Part

22. In 21.32(b)(2), remove “(HFI-30)” and in its place add “(ELEM-1029)”.

End Amendment Part
[Amended]
Start Amendment Part

23. 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 Part
[Amended]
Start Amendment Part

24. 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 Part
[Amended]
Start Amendment Part

25. 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 Part

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

End Part Start Amendment Part

26. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.

End Authority Start Amendment Part

27. In § 314.53(e), revise the last two sentences to read as follows:

End Amendment Part
Submission of patent information.
* * * * *

(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.

* * * * *
Start Part

PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

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28. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

End Authority
[Amended]
Start Amendment Part

29. 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 Part

PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

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30. The authority citation for part 516 continues to read as follows:

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Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

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[Amended]
Start Amendment Part

31. 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 Part

PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

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32. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.

End Authority
[Amended]
Start Amendment Part

33. 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 Signature

Dated: May 18, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2011-13488 Filed 5-31-11; 8:45 am]

BILLING CODE 4160-01-P

Published Document