68114 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Rules and Regulations 

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. 

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 

■ 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. 

■ 2. In § 5.1110, revise paragraph (b) to 

read as follows: 

§ 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 

■ 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. 

§ 10.85 [Amended] 

■ 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)’’. 

§ 10.90 [Amended] 

■ 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)’’. 

§ 10.95 [Amended] 

■ 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 

■ 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. 

§ 14.65 [Amended] 

■ 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 

■ 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. 

§ 20.3 [Amended] 

■ 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.’’ 

■ 11. In § 20.26, revise paragraph (b) to 

read as follows: 

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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Rules and Regulations 68115 

§ 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. 

§ 20.30 [Amended] 

■ 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.’’ 

■ 13. In § 20.40, revise paragraph (a) to 

read as follows: 

§ 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. 

* * * * * 

§ 20.107 [Amended] 

■ 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.’’ 

■ 15. In § 20.120, revise paragraph (a) to 

read as follows: 

§ 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 

■ 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. 

§ 21.32 [Amended] 

■ 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)’’. 

§ 21.40 [Amended] 

■ 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)’’. 

§ 21.41 [Amended] 

■ 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)’’. 

§ 21.43 [Amended] 

■ 20. Section 21.43 is amended in 

paragraph (a)(2) by removing ‘‘at the 

address shown in § 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)’’. 

§ 21.52 [Amended] 

■ 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 

■ 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. 

■ 23. In § 314.53, in paragraph (e), 

revise the last sentence to read as 

follows: 

§ 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-THECOUNTER HUMAN USE 

■ 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. 

§ 350.60 [Amended] 

■ 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 

■ 26. The authority citation for part 516 

continues to read as follows: 

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

371. 

■ 27. In § 516.157, revise paragraph (a) 

to read as follows: 

§ 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 

■ 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. 

■ 29. In § 814.45, revise paragraph (d)(2) 

to read as follows: 

§ 814.45 Denial of approval of a PMA. 

* * * * * 

(d) * * * 

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68116 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Rules and Regulations 

(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 

DEPARTMENT OF STATE 

22 CFR Part 181 

[Public Notice 8921] 

RIN 1400–AD53 

Publication, Coordination, and 

Reporting of International Agreements 

ACTION: Final rule. 

SUMMARY: The Department of State 

(‘‘Department’’) finalizes a proposed 

rule to add additional categories of 

international agreements to be exempted 

from the requirement to publish in the 

Treaties and Other International Acts 

Series (TIAS). The TIAS is the official 

treaty series of the United States and 

serves as evidence of the treaties, and 

international agreements other than 

treaties, in all courts of law and equity 

and of maritime jurisdiction, and in all 

the tribunals and public offices of the 

United States and of the several States, 

without any need of further proof or 

authentication. Certain international 

agreements may be exempted from 

publication in TIAS if the Department of 

State provides notice in its regulations. 

This rule adds three categories of 

international agreements that are not 

required to be published in TIAS. 

DATES: This rule is effective on 

November 14, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mattler, Treaty Affairs, Office 

of the Legal Adviser, Department of 

State, Washington, DC 20520, (202) 

647–1345, or at treatyoffice@state.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 1 U.S.C. 112a, the Secretary of State 

is required to cause to be published 

annually a compilation of all treaties 

and international agreements to which 

the United States is a party that were 

signed, proclaimed, or ‘‘with reference 

to which any other final formality ha[d] 

been executed’’ during the calendar 

year. 

The Secretary of State, however, may 

determine that publication of particular 

categories of agreements is not required 

if certain criteria are met, which are 

listed in 1 U.S.C. 112a(b). The three 

categories of international agreements 

that are exempted by this rule (and 

which are now included in 22 CFR 

181.8) are: 

(1) Bilateral acquisition and cross 

servicing agreements and logistics 

support agreements governing the 

mutual exchange of logistics support, 

supplies and services with the military 

of certain countries or international 

organizations. 

(2) Bilateral agreements relating to the 

provision of health care to military 

personnel on a reciprocal basis. 

(3) Bilateral agreements for the 

reduction of intergovernmental debts. 

Further description of these types of 

international agreements is included in 

the notice of proposed rulemaking. In 

addition to these changes, the 

Department amends 22 CFR 181.8(a)(9) 

to refer to the newer Executive Order 

dealing with classified information. 

The Department of State received no 

comments on the proposed rule. 

Regulatory Analysis 

For the complete regulatory analysis 

regarding this rulemaking, please refer 

to the analysis included in the notice of 

proposed rulemaking, which is adopted 

herein. 

List of Subjects in 22 CFR Part 181 

Treaties. 

For the reasons set forth above, 22 

CFR part 181 is amended as follows: 

PART 181—[AMENDED] 

■ 1. The authority citation for part 181 

continues to read as follows: 

Authority: 1 U.S.C. 112a, 112b; and 22 

U.S.C. 2651a. 

■ 2. Amend § 181.8 by: 

■ a. Revising paragraphs (a)(9), (12), and 

(13) and adding paragraphs (a)(14), (15), 

and (16); and 

■ b. Revising paragraph (b). 

The revisions and additions read as 

follows: 

§ 181.8 Publication. 

(a) * * * 

(9) Agreements that have been given 

a national security classification 

pursuant to Executive Order No. 13526, 

its predecessors, or its successors; 

* * * * * 

(12) Bilateral agreements that apply to 

specified education and leadership 

development programs designed to 

acquaint U.S. and foreign armed forces, 

law enforcement, homeland security, or 

related personnel with limited, 

specialized aspects of each other’s 

practices or operations; 

(13) Bilateral agreements between 

aviation agencies governing specified 

aviation technical assistance projects for 

the provision of managerial, operational, 

and technical assistance in developing 

and modernizing the civil aviation 

infrastructure; 

(14) Bilateral acquisition and cross 

servicing agreements and logistics 

support agreements; 

(15) Bilateral agreements relating to 

the provision of health care to military 

personnel on a reciprocal basis; and 

(16) Bilateral agreements for the 

reduction of intergovernmental debts. 

(b) In addition to those listed in 

paragraph (a) of this section, the 

following categories of agreements will 

not be published in United States 

Treaties and Other International 

Agreements: 

(1) Agreements on the subjects listed 

in paragraphs (a)(1) through (9) of this 

section that had not been published as 

of February 26, 1996; 

(2) Agreements on the subjects listed 

in paragraphs (a)(10) through (13) of this 

section that had not been published as 

of September 8, 2006; and 

(3) Agreements on the subjects listed 

in paragraphs (a)(14) through (16) of this 

section that had not been published as 

of November 14, 2014. 

* * * * * 

Dated: November 5, 2014. 

Michael J. Mattler, 

Assistant Legal Adviser for Treaty Affairs, 

Department of State. 

[FR Doc. 2014–27006 Filed 11–13–14; 8:45 am] 

BILLING CODE 4710–08–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Pension Benefit Guaranty Corporation’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans to 

prescribe interest assumptions under 

the regulation for valuation dates in 

December 2014. The interest 

assumptions are used for paying 

benefits under terminating singleemployer plans covered by the pension 

insurance system administered by 

PBGC. 

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