48756 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Rules and Regulations

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1014

Privacy Act of 1974; Specific

Exemptions

AGENCY: Consumer Product Safety

Commission.

ACTION: Final rule.

SUMMARY: The Consumer Product Safety

Commission (‘‘Commission’’) is issuing

a rule to exempt a system of records

from certain provisions of the Privacy

Act of 1974, 5 U.S.C. 552a (‘‘Privacy

Act’’), to the extent that the system

contains investigatory material

pertaining to the enforcement of

criminal laws or compiled for law

enforcement purposes.

DATES: Effective September 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Joseph F. Rosenthal, Office of the

General Counsel, Consumer Product

Safety Commission, Washington, DC

20207, telephone 301–504–0980.

SUPPLEMENTARY INFORMATION:

The Consumer Product Safety

Commission, under a variety of statutes,

is authorized to enforce its statutes and

regulations through administrative

actions and civil and criminal litigation.

Preparation for, and conduct of,

enforcement actions requires the

compilation of investigatory materials

such as memoranda, investigative

reports, correspondence, test reports,

injury reports, and the like in a manner

that facilitates easy retrieval. The two

offices of the Commission that conduct

enforcement actions, the Office of

Compliance and the Office of the

General Counsel, maintain such

documentation in a system of records,

identified as ‘‘Enforcement and

Litigation Files—CPSC–7.’’ Disclosure

of information in these investigatory

files or disclosure of the identity of

confidential sources could seriously

undermine the effectiveness of the

Commission’s enforcement actions. For

example, premature disclosure of

information in such files could enable

subjects of an enforcement action to

conceal or destroy evidence, or escape

prosecution. Premature disclosure of

this information could also lead to the

possible intimidation of, or harm to,

informants, witnesses, or Commission

personnel and their families. Further,

the imposition of certain Privacy Act

restrictions on the manner in which

information is collected, verified, or

retained could significantly impede the

effectiveness of an enforcement action.

Section (k)(2) of the Privacy Act, 5

U.S.C. 552a(k)(2), provides the authority

for agencies to exempt records

containing investigatory material

compiled for law enforcement purpose

from certain other provisions of the Act.

16 CFR 1014.12 currently exempts other

systems of records from certain

requirements of the Privacy Act. The

Commission proposed on June 2, 1997,

62 FR 29680, to add a new paragraph (c)

to § 1014.12 to exempt the enforcement

and litigation files from certain

requirements of the Privacy Act.

No comments have been received and

the Commission is now issuing the

proposal as a final rule.

Pursuant to section 605(b) of the

Regulatory Flexibility Act, 5 U.S.C.

605(b), the Commission certifies that

this rule will not have a significant

impact on a substantial number of small

entities. Since the rule does not require

any actions to be taken, the Commission

also certifies that this rule will have no

environmental impact, will not preempt

any state or local laws or regulations,

will have no impact on family

maintenance and well being, and no

implications for federalism.

List of Subjects in 16 CFR Part 1014

Privacy.

For the reason stated in the preamble,

Chapter II, Title 16 of the Code of

Federal Regulations is amended as

follows:

PART 1014—POLICIES AND

PROCEDURES IMPLEMENTING THE

PRIVACY ACT OF 1974

1. The authority citation for part 1014

continues to read as follows:

Authority: Privacy Act of 1974 (5 U.S.C.

552a).

§ 1014.12 [Amended]

2. Section 1014.12, Specific

exemptions, is amended by adding

paragraph (c) to read as follows:

* * * * *

(c) Enforcement and Litigation Files—

CPSC–7. All portions of this system of

records that fall within 5 U.S.C.

552a(k)(2) (investigatory materials

compiled for law enforcement purposes)

are exempt from 5 U.S.C. 552a(c)(3)

(mandatory accounting of disclosures); 5

U.S.C. 552a(d) (access by individuals to

records that pertain to them); 5 U.S.C.

552a(e)(1) (requirement to maintain only

such information as is relevant and

necessary to accomplish an authorized

agency purpose); 5 U.S.C. 552a(e)(4)(G)

(mandatory procedures to notify

individuals of the existence of records

pertaining to them); 5 U.S.C.

552a(e)(4)(H) (mandatory procedures to

notify individuals how they can obtain

access to and contest records pertaining

to them); 5 U.S.C. 552a(e)(4)(I)

(mandatory disclosure of records source

categories); and the Commission’s

regulations in 16 CFR part 1014 that

implement these statutory provisions.

Dated: September 12, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–24715 Filed 9–16–97; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Office of the

Commissioner

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

general redelegations of authority from

the Commissioner of Food and Drugs

(the Commissioner) to other officers of

FDA. The amendment delegates to the

Deputy Commissioner for Policy and the

Associate Commissioner for Policy

Coordination authority to certify that a

proposed or final rule, if issued, will not

have a significant economic impact on

a substantial number of small entities.

Furthermore, the Deputy Commissioner

for Policy has redelegated the

aformentioned authority to certain FDA

officials authorized to issue Federal

Register documents. These actions are

necessary to ensure the accuracy of the

regulations.

EFFECTIVE DATE: June 25, 1997.

FOR FURTHER INFORMATION CONTACT:

Edwin V. Dutra, Regulations Policy

and Management Staff (HF–26),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–3480, or

Loretta W. Davis, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

4809.

SUPPLEMENTARY INFORMATION: FDA is

amending its delegations of authority

regulations by revising 21 CFR 5.20 and

by adding § 5.100 to reflect additional

authorities under the Regulatory

Flexibility Act (5 U.S.C. 605(b)). On
Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Rules and Regulations 48757

November 8, 1996, the Commissioner

delegated to the Deputy Commissioner

for Policy and the Associate

Commissioner for Policy Coordination

his authority, as head of the agency

under the Regulatory Flexibility Act (5

U.S.C. 605(b)), to certify that a proposed

or final rule, if issued, will not have a

significant economic impact on a

substantial number of small entities.

The Commissioner authorized the

Deputy Commissioner for Policy and the

Associate Commissioner for Policy

Coordination to redelegate this

authority.

Moreover, in a memorandum dated

June 25, 1997, the Deputy

Commissioner for Policy redelegated to

certain FDA officials authorized to issue

Federal Register documents the

authority to make a certification under

5 U.S.C. 605(b) for any notice of

proposed rulemaking and for any final

rule that such official is authorized to

issue. Authority delegated to a position

by title may be exercised by a person

officially designated to serve in such

position in an acting capacity or on a

temporary basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; secs. 2–12 of the Fair Packaging

and Labeling Act (15 U.S.C. 1451–1461); 21

U.S.C. 41–50, 61–63, 141–149, 467f, 679(b),

801–886, 1031–1309; secs. 201–903 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321–394); 35 U.S.C. 156; secs. 301,

302, 303, 307, 310, 311, 351, 352, 361, 362,

1701–1706, 2101 of the Public Health Service

Act (42 U.S.C. 241, 242, 242a, 242l, 242n,

243, 262, 263, 264, 265, 300u-300u-5, 300aa1); 42 U.S.C. 1395y, 3246b, 4332, 4831(a),

10007–10008; E.O. 11490, 11921, and 12591.

2. Section 5.20 is amended by adding

paragraph (f)(4) to read as follows:

§ 5.20 General redelegations of authority

from the Commissioner to other officers of

the Food and Drug Administration.

(f) * * *

(4) The Deputy Commissioner for

Policy and the Associate Commissioner

for Policy Coordination are authorized

under the Regulatory Flexibility Act (5

U.S.C. 605(b)) to certify that a proposed

or final rule, if issued, will not have a

significant economic impact on a

substantial number of small entities.

The delegation excludes the authority to

submit reports to Congress.

* * * * *

3. Section 5.100 is added to subpart

C to read as follows:

§ 5.100 Officials authorized to make

certification under 5 U.S.C. 605(b) for any

proposed and final rules.

The following officials are authorized

to perform all the functions of the

Commissioner of Food and Drugs with

regard to decisions made under the

Regulatory Flexibility Act (5 U.S.C.

605(b)), to certify that a proposed or

final rule, if issued, will not have a

significant economic impact on a

substantial number of small entities:

(a) The Associate Commissioner for

Regulatory Affairs (ACRA).

(b) The Director, Center for Biologics

Evaluation and Research (CBER).

(c) The Director, Center for Drug

Evaluation and Research (CDER).

(d) The Director, Center for Devices

and Radiological Health (CDRH).

(e) The Director, Center for Food

Safety and Applied Nutrition (CFSAN).

(f) The Director, Center for Veterinary

Medicine (CVM).

(g) Other FDA Officials Authorized to

Issue Federal Register Documents.

Dated: September 9, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24582 Filed 9–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 171

[Public Notice No. 2588]

Office of Information Resources

Management Programs and Services;

Access to Information—Freedom of

Information Provisions

AGENCY: Office of Information Resources

Management Programs and Services,

Department of State.

ACTION: Interim rule with request for

comment.

SUMMARY: The Department of State is

hereby promulgating interim rules and

soliciting comments prior to adoption of

final rules to implement its obligations

under the Freedom of Information Act

relating to requests for expeditious

processing of requests.

DATES: The interim rule is effective on

October 2, 1997. Comments must be

submitted on or before November 17,

1997.

ADDRESSES: Written comments may be

mailed or delivered to the Information

and Privacy Coordinator, Office of

Information Resources Management

Programs and Services, Room 1239,

Department of State, 2201 C Street,

N.W., Washington, D.C. 20520–1239.

FOR FURTHER INFORMATION CONTACT:

Margaret P. Grafeld, Acting Director,

Office of Information Resources

Management Programs and Services,

Room 1239, Department of State, 2201

C Street, NW, Washington, D.C. 20520–

1239; telephone (202) 647–7740;

facsimile (202) 647–5094.

SUPPLEMENTARY INFORMATION: This

document promulgates interim rules

and seeks public comment. The agency

is compelled to comply with the

mandates of the Electronic Freedom of

Information Act (E–FOIA) Amendments

of 1996 legislation, and applicable

deadlines, which require new

procedures to become effective October

2, 1997. This interim rule revises 22

CFR 171.12 to bring these regulations

into conformity with the new statutory

provisions set forth in the (E–FOIA)

Amendments related to time limits for

response and consideration of requests

for expedited processing of Freedom of

Information Act inquiries. Therefore,

the agency waives publication of a

proposed rule in accordance with the

‘‘good cause’’ provision of the

Administrative Procedure Act, 5 U.S.C.

553. The rule is not expected to have a

significant impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

Nor does it impose unfunded mandates

under the Unfunded Mandates Reform

Act. This rule does not alter

substantially any existing rights of

members of the public. In addition, the

rule does not impose information

collection requirements under the

provisions of the Paperwork Reduction

Act of 1980. The rule is exempt from

review under E.O. 12866, but has been

reviewed internally by the Department

to ensure consistency with the

objectives thereof.

List of Subjects in 22 CFR Part 171

Administrative practice and

procedure, Classified information,

Confidential business information,

Freedom of information, Privacy.

For the reasons set forth in the

preamble, 22 CFR part 171 is amended

as follows: