
[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Rules and Regulations]
[Pages 68114-68116]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26914]



[[Page 68114]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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


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

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 change the Division of Freedom of Information's 
(FOI's) name, and remove the address, telephone number, fax number, and 
Public Reading Room fax number and room number and replace them with 
FOI's address located on the Agency's Web site. This action is 
editorial in nature and is intended to improve the accuracy of the 
Agency's regulations.

DATES: This rule is effective November 14, 2014.

FOR FURTHER INFORMATION CONTACT: Sarah Kotler, Freedom of Information 
Staff, Food and Drug Administration, 301-796-8975, address available on 
the Agency's Web site at http://www.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is making technical amendments in the 
Agency's regulations under 21 CFR parts 5, 10, 14, 20, 21, 314, 350, 
516, and 814 as a result of a recent office move. The office name and 
address was ``Division of Freedom of Information (ELEM-1029), 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857''. The new office name 
and address is listed on the Agency's Web site at http://www.fda.gov. 
The Freedom of Information Staff's new Public Reading Room number is 
listed on the Agency's Web site at http://www.fda.gov. 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 20

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

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, 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. In Sec.  5.1110, revise paragraph (b) to read as follows:


Sec.  5.1110  FDA public information offices.

* * * * *
    (b) Freedom of Information Staff. The Freedom of Information 
Staff's Public Reading Room is located at the address available on the 
Agency's Web site at http://www.fda.gov.
* * * * *

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. Section 10.85 is amended in paragraph (d)(4) by removing ``(ELEM-
1029)'' and adding in its place ``(the Freedom of Information Staff's 
address is available on the Agency's Web site at http://www.fda.gov)''.


Sec.  10.90  [Amended]

0
5. Section 10.90 is amended in paragraph (d) by removing ``(ELEM-
1029)'' and adding in its place ``(the Freedom of Information Staff's 
address is available on the Agency's Web site at http://www.fda.gov)''.


Sec.  10.95  [Amended]

0
6. Section 10.95 is amended in paragraphs (b)(2), (c)(2), (d)(2), 
(d)(7), and (d)(8) by removing ``(ELEM-1029)'' and adding in its place 
``(the Freedom of Information Staff's address is available on the 
Agency's Web site at http://www.fda.gov)''.

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, Pub. 
L. 113-54.


Sec.  14.65  [Amended]

0
8. Section 14.65 is amended in paragraph (c) by removing ``(ELEM-
1029)'' and by adding in its place ``(the Freedom of Information 
Staff's address is available on the Agency's Web site at http://www.fda.gov)''.

PART 20--PUBLIC INFORMATION

0
9. 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.


Sec.  20.3  [Amended]

0
10. Section 20.3 is amended in paragraph (b) by removing ``(ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857'' and adding in its place '' at the address located 
on the Agency's Web site at http://www.fda.gov.''
0
11. In Sec.  20.26, revise paragraph (b) to read as follows:

[[Page 68115]]

Sec.  20.26  Indexes of certain records.

* * * * *
    (b) Each such index will be made available by accessing the 
Agency's Web site at http://www.fda.gov. A printed copy of each index 
is available by writing or visiting the Freedom of Information Staff's 
address on the Agency's Web site at http://www.fda.gov.


Sec.  20.30  [Amended]

0
12. Section 20.30 is amended in paragraph (a) by removing ``(ELEM-
1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857'' and adding in its place ``at the address located 
on the Agency's Web site at http://www.fda.gov.''
0
13. In Sec.  20.40, revise paragraph (a) 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 Freedom of 
Information Staff at the address on the Agency's Web site at http://www.fda.gov or by faxing it to the fax number listed on the Agency's 
Web site at http://www.fda.gov. 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.  20.107  [Amended]

0
14. Section 20.107 is amended in paragraph (a) by removing ``(ELEM-
1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857'' and adding in its place ``at the address located 
on the Agency's Web site at http://www.fda.gov.''
0
15. In Sec.  20.120, revise paragraph (a) to read as follows:


Sec.  20.120  Records available in Food and Drug Administration Public 
Reading Rooms.

    (a) The Freedom of Information Staff and the Division of Dockets 
Management Public Reading Room are located at the same address. Both 
are located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The 
telephone number for the Division of Docket Management is 301-827-6860; 
the telephone number for the Freedom of Information Staff's Public 
Reading Room is located at the address on the Agency's Web site at 
http://www.fda.gov. Both public reading rooms are open from 9 a.m. to 4 
p.m., Monday through Friday, excluding legal public holidays.
* * * * *

PART 21--PROTECTION OF PRIVACY

0
16. 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
17. Section 21.32 is amended in paragraph (b)(2) in the second sentence 
by removing ``(HFA-400), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857'' and by adding in its place ``HR-BETHPL 
RM7114, HFA-705, 7700 Wisconsin Ave., 7th & 8th floors, Bethesda, MD 
20814'' and in the third sentence by removing ``(ELEM-1029)'' and by 
adding in its place ``(the Privacy Act Coordinator is part of the 
Freedom of Information Staff, the address for which is located on the 
Agency Web site at http://www.fda.gov)''.


Sec.  21.40  [Amended]

0
18. Section 21.40 is amended in paragraph (b) by removing ``(ELEM-
1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857'' and by adding in its place ``(address is located 
on the Agency Web site at http://www.gov.fda)''.


Sec.  21.41  [Amended]

0
19. Section 21.41 is amended in paragraphs (c) and (e) by removing 
``(ELEM-1029)'' and by adding in its place ``(address is located on the 
Agency Web site at http://www.gov.fda)''.


Sec.  21.43  [Amended]

0
20. Section 21.43 is amended in paragraph (a)(2) by removing ``at the 
address shown in Sec.  20.30 of this chapter'' and by adding in its 
place ``(address is located on the Agency's Web site at http://www.fda.gov)''.


Sec.  21.52  [Amended]

0
21. Section 21.52 is amended in paragraph (a) by removing ``, Rm. 14-
71, 5600 Fishers Lane, Rockville, MD 20857'' and by adding in its place 
``(see the address on the Agency's Web site at http://www.fda.gov)''.

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

0
22. 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
23. In Sec.  314.53, in paragraph (e), revise the last sentence to read 
as follows:


Sec.  314.53  Submission of patent information.

* * * * *
    (e) * * * A request for copies of the file shall be sent in writing 
to the Freedom of Information Staff at the address listed on the 
Agency's Web site at http://www.fda.gov.
* * * * *

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

0
24. 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
25. Section 350.60 is amended by removing ``(ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 
20857'' and adding in its place ``(address is located on the Agency's 
Web site at http://www.fda.gov.''

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

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

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

0
27. In Sec.  516.157, revise paragraph (a) to read as follows:


Sec.  516.157  Publication of the index and content of an index 
listing.

    (a) FDA will make the list of indexed drugs available through the 
FDA Web site at http://www.fda.gov. A printed copy can be obtained by 
writing to the Freedom of Information Staff or by visiting FDA's 
Freedom of Information Staff's Public Reading Room at the address 
listed on the Agency's Web site at http://www.fda.gov.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
28. 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.


0
29. In Sec.  814.45, revise paragraph (d)(2) to read as follows:


Sec.  814.45  Denial of approval of a PMA.

* * * * *
    (d) * * *

[[Page 68116]]

    (2) A request for copies of the current PMA approvals and denials 
document and copies of summaries of safety and effectiveness shall be 
sent in writing to the Freedom of Information Staff's address listed on 
the Agency's Web site at http://www.fda.gov.
* * * * *

    Dated: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26914 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P


