[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Rules and Regulations]
[Pages 31468-31470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814

[Docket No. FDA-2011-N-0318]


Division of Freedom of Information; Change of Office Name, 
Address, Telephone Number, and Fax Number; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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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.

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.

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.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 19

    Conflict of interests.

21 CFR Part 20

    Confidential business information, Courts, Freedom of Information, 
Government employees.

[[Page 31469]]

21 CFR Part 21

    Privacy.

21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 350

    Labeling, Over-the-counter drugs.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Part 814

    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:

PART 5--ORGANIZATION

0
1. The authority citation for 21 CFR part 5 continues to read as 
follows:

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

0
2. Revise Sec.  5.1110(b) to read as follows:


Sec.  5.1110  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.
* * * * *

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
3. The authority citation for 21 CFR part 10 continues to read as 
follows:

    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.


Sec.  10.85  [Amended]

0
4. In Sec.  10.85(d)(4), remove ``Freedom of Information Staff (HFI-
35)'' and in its place add ``Division of Freedom of Information (ELEM-
1029)''.


Sec.  10.90  [Amended]

0
5. In Sec.  10.90(d), remove ``Freedom of Information Staff (HFI-35),'' 
and in its place add ``Division of Freedom of Information (ELEM-
1029)''.


Sec.  10.95  [Amended]

0
6. In Sec.  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)''.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
7. The authority citation for 21 CFR part 14 continues to read as 
follows:

    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.


Sec.  14.65  [Amended]

0
8. In Sec.  14.65(c), remove ``Freedom of Information Staff (HFI-35)'' 
and in its place add ``Division of Freedom of Information (ELEM-
1029)''.

PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

0
9. The authority citation for 21 CFR part 19 continues to read as 
follows:

    Authority:  21 U.S.C. 371.


Sec.  19.10  [Amended]

0
10. In Sec.  19.10(d) introductory text, remove ``Freedom of 
Information Staff'' and in its place add ``Division of Freedom of 
Information''.

PART 20--PUBLIC INFORMATION

0
11. The authority citation for 21 CFR part 20 continues to read as 
follows:

    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.

0
12. Revise Sec.  20.3(b) to read as follows:


Sec.  20.3  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.

0
13. Revise Sec.  20.26(b), to read as follows:


Sec.  20.26  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.

0
14. Revise Sec.  20.30 to read as follows:


Sec.  20.30  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.

0
15. In Sec.  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:


Sec.  20.40  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.
* * * * *


Sec.  20.41  [Amended]

0
16. In Sec.  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''.


Sec.  20.44  [Amended]

0
17. In Sec.  20.44(e), remove ``Freedom of Information Staff'' and in 
its place add ``Division of Freedom of Information''.

0
18. In Sec.  20.107(a), revise the second sentence to read as follows:


Sec.  20.107  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,

[[Page 31470]]

located in rm. 1050, at the same address. * * *
* * * * *

0
19. In Sec.  20.108, remove ``Freedom of Information Public Room'' 
everywhere it appears and in its place add ``Division of Freedom of 
Information Public Reading Room''.

0
20. In Sec.  20.120, revise paragraph (a); paragraph (b) introductory 
text; and paragraph (b)(4) to read as follows:


Sec.  20.120  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
* * * * *

PART 21--PROTECTION OF PRIVACY

0
21. The authority citation for 21 CFR part 21 continues to read as 
follows:

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


Sec.  21.32  [Amended]

0
22. In 21.32(b)(2), remove ``(HFI-30)'' and in its place add ``(ELEM-
1029)''.


Sec.  21.40  [Amended]

0
23. In Sec.  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.,''.


Sec.  21.41  [Amended]

0
24. In Sec.  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.


Sec.  21.43  [Amended]

0
25. In Sec.  21.43(a)(2), remove ``Freedom of Information Staff public 
room'' and in its place add ``Division of Freedom of Information Public 
Reading Room''.

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

0
26. The authority citation for 21 CFR part 314 continues to read as 
follows:

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


0
27. In Sec.  314.53(e), revise the last two sentences to read as 
follows:


Sec.  314.53  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.
* * * * *

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

0
28. The authority citation for 21 CFR part 350 continues to read as 
follows:

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


Sec.  350.60  [Amended]

0
29. In Sec.  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.,''.

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

0
30. The authority citation for part 516 continues to read as follows:

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


Sec.  516.157  [Amended]

0
31. In Sec.  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''.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
32. The authority citation for 21 CFR part 814 continues to read as 
follows:

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


Sec.  814.45  [Amended]

0
33. In Sec.  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.,''.

    Dated: 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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