Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Rules and Regulations 26825

List of Subjects in 16 CFR Part 1000

Organization and functions

(government agencies).

Accordingly, 16 CFR part 1000 is

amended as follows:

PART 1000—[AMENDED]

1. The authority citation for part 1000

continues to read as follows:

Authority: 5 U.S.C. 552(a).

2. Section 1000.12 is revised to read

as follows:

§ 1000.12 Organizational structure.

The Consumer Product Safety

Commission is composed of the

principal units listed in this section.

(a) The following units report directly

to the Chairman of the Commission:

(1) Office of the General Counsel;

(2) Office of Congressional Relations;

(3) Office of the Secretary;

(4) Office of the Inspector General;

(5) Office of Equal Employment

Opportunity and Minority Enterprise;

(6) Office of the Executive Director.

(b) The following units report directly

to the Executive Director of the

Commission:

(1) Office of the Budget;

(2) Office of Hazard Identification and

Reduction;

(3) Office of Information and Public

Affairs;

(4) Office of Compliance;

(5) Office of Planning and Evaluation;

(6) Office of Human Resources

Management;

(7) Office of Information Services;

(8) Directorate for Administration;

(9) Directorate for Field Operations.

(c) The following units report directly

to the Assistant Executive Director for

Hazard Identification and Reduction:

(1) Directorate for Epidemiology;

(2) Directorate for Economic Analysis;

(3) Directorate for Health Sciences;

(4) Directorate for Engineering

Sciences;

(5) Directorate for Laboratory

Sciences.

3. The heading of section 1000.24 is

revised to read as follows:

§ 1000.24 Office of Compliance.

* * * * *

4. Section 1000.26 is revised to read

as follows:

§ 1000.26 Office of Information Services.

The Office of Information Services,

which is managed by the Assistant

Executive Director for Information

Services, is responsible for general

policy, controlling and conducting

managerial activities and operations

relating to the collection, use, and

dissemination of information by the

agency. The Office manages the

Commission’s information system that

supports all its program activities. The

Office provides automated data

processing and operational support for

data collection, information retrieval,

report generation, electronic mail, and

statistical and mathematical operations

of the agency. The Office maintains the

agency’s local area networks and

develops and supports other network

applications. The Office develops plans

for improving agency operations

through the use of information

technology. The Office’s functional

responsibilities include planning,

organizing, and directing information

resources management (including

records management and related

requirements), and the managing of the

agency’s management directives system.

The Office manages the Commission’s

telecommunications services including

the agency’s toll-free Hotline by which

the public reports hazardous consumer

products and receives information about

product recalls and product hazards. It

also oversees operation of the

Commission’s Internet and fax-ondemand services.

5. Section 1000.32 is revised to read

as follows:

§ 1000.32 Directorate for Administration.

The Directorate for Administration,

which is managed by the Associate

Executive Director for Administration,

is responsible for formulating general

administrative policies supporting the

Commission in the areas of financial

management, procurement, and general

administrative support services

including property and space

management, physical security,

printing, and warehousing. The

Directorate is responsible for the

payment, accounting, and reporting of

all expenditures within the Commission

and for operating and maintaining the

Commission’s accounting system and

subsidiary Management Information

System which allocates staff work time

and costs to programs and projects.

§§ 1000.7, 1000.19 and 1000.24 [Amended]

6. Part 1000 is further amended by

removing the term ‘‘Compliance and

Enforcement’’ each time it appears and

inserting the term ‘‘Compliance’’ in its

place, in the following locations:

a. Section 1000.7(b) (two times).

b. Section 1000.19.

c. Section 1000.24 (two times).

Dated: May 15, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 95–12280 Filed 5–18–95; 8:45 am]

BILLING CODE 6335–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

covering the certification of true

documents and use of the Department

seal in order to update this authority to

reflect recent changes to organizational

structures within FDA.

EFFECTIVE DATE: May 19, 1995.

FOR FURTHER INFORMATION CONTACT:

L’Tonya Barnes, Division of

Management Systems and Policy (HFA–

340), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–4976.

SUPPLEMENTARY INFORMATION: FDA is

amending the regulations in § 5.22

Certification of true copies and use of

Department seal (21 CFR 5.22) in order

to update this authority to reflect recent

changes to organizational structures

within FDA. Revisions and deletions

have been made to reflect current titles.

Also, the following additions have been

made to bring the list of officials up-todate: the Deputy Commissioners; the

Director, Division of Management

Operations, and Chief, Administrative

Management Branch, Office of Resource

Management, Office of Regulatory

Affairs (ORA); the Director, FDA History

Staff, ORA; the Director, Office of

Policy, Planning, and Strategic

Initiatives, Center for Food Safety and

Applied Nutrition (CFSAN); the

Director, Office of Management

Systems, CFSAN; the Director, Office of

Cosmetics and Colors, CFSAN; the

Director, Office of Plant and Dairy

Foods and Beverages, CFSAN; the

Director, Office of Seafood, CFSAN; the

Director, Office of Special Nutritionals,

CFSAN; the Director, Office of Special

Research Skills, CFSAN; the Director,

Office of Constituent Operations,

CFSAN; the Director, Office of Field

Programs, CFSAN; the Director, Office

of Premarket Approval, CFSAN; the

Director, Office of Scientific Analysis

and Support, CFSAN; and the Director,

National Forensic Chemistry Center.

Further redelegation of the authority

delegated is not authorized at this time.

Authority delegated to a position by title

may be exercised by a person officially
26826 Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Rules and Regulations

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, 354, 361,

362, 1701–1706; 2101, 2125, 2127, 2128 of

the Public Health Service Act (42 U.S.C. 241,

242, 242a, 242l, 242n, 243, 262, 263, 263b,

264, 265, 300u–300u–5, 300aa–1, 300aa–25,

300aa–27, 300aa–28); 42 U.S.C. 1395y,

3246b, 4332, 4831(a), 10007–10008; E.O.

11490, 11921, and 12591; secs. 312, 313, 314

of the National Childhood Vaccine Injury Act

of 1986, Pub. L. 99–660 (42 U.S.C. 300aa–1

note).

2. Section 5.22 is amended by revising

paragraphs (a)(1) through (a)(13) and by

adding new paragraph (a)(14), by

revising paragraphs (b)(1) and (b)(2),

and by adding new paragraph (b)(3) to

read as follows:

§ 5.22 Certification of true copies and use

of Department seal.

(a) * * *

(1) The Deputy Commissioners.

(2) The Associate and Deputy

Associate Commissioners.

(3)(i) The Director, Office of Executive

Operations.

(ii) The Director, Executive

Secretariat.

(iii) The Director, Program

Management Staff.

(4) The Executive Assistant to the

Commissioner, Office of the

Commissioner.

(5)(i) The Director and Deputy

Director, Office of Enforcement, Office

of Regulatory Affairs (ORA).

(ii) The Director and Deputy Director,

Office of Regional Operations, ORA.

(iii) The Director and Deputy Director,

Office of Resource Management, ORA.

(iv) The Director, Division of

Management Operations, and Chief,

Administrative Management Branch,

Office of Resource Management, ORA.

(v) The Director, FDA History Staff,

ORA.

(6)(i) The Director, Division of

Management Systems and Policy, Office

of Management (OM).

(ii) The Chief, Dockets Management

Branch, Division of Management

Systems and Policy, OM.

(7) The Director, Freedom of

Information Staff, Office of Public

Affairs.

(8)(i) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(ii) The Director, Office of

Management, CBER.

(iii) The Directors and Deputy

Directors of the Office of Compliance,

CBER.

(iv) The Director of Congressional and

Public Affairs Staff, Office of the Center

Director, CBER.

(v) The Chief, Surveillance and Policy

Branch and Consumer Safety Officers,

Office of Compliance, CBER.

(9)(i) The Director and Deputy

Directors, Center for Food Safety and

Applied Nutrition (CFSAN).

(ii) The Director, Office of Policy,

Planning, and Strategic Initiatives,

CFSAN.

(iii) The Director, Office of

Management Systems, CFSAN.

(iv) The Director, Office of Cosmetics

and Colors, CFSAN.

(v) The Director, Office of Plant and

Dairy Foods Beverages, CFSAN.

(vi) The Director, Office of Seafood,

CFSAN.

(vii) The Director, Office of Special

Nutritional, CFSAN.

(viii) The Director, Office of Special

Research Skills, CFSAN.

(ix) The Director, Office of

Constituent Operations, CFSAN.

(x) The Director, Office of Field

Programs, CFSAN.

(xi) The Director, Office of Premarket

Approval, CFSAN.

(xii) The Director, Office of Scientific

Analysis and Support, CFSAN.

(10)(i) The Director and Deputy

Director, Center for Devices and

Radiological Health (CDRH).

(ii) The Director, Office of

Management Services, CDRH.

(iii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iv) The Director and Deputy Director,

Division of Compliance Programs,

CDRH.

(v) The Director and Deputy Director,

Office of Standards and Regulations,

CDRH.

(11)(i) The Director and Deputy

Directors, Center for Veterinary

Medicine (CVM).

(ii) The Director and Deputy Director,

Office of Management, CVM.

(iii) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(iv) The Director, Division of

Compliance, Office of Surveillance and

Compliance, CVM.

(v) The Chief, Case Guidance Branch,

Division of Compliance, Office of

Surveillance and Compliance, CVM.

(12)(i) The Director and Deputy

Director, National Center for

Toxicological Research (NCTR).

(ii) The Director, Office of Research

Support, NCTR.

(13)(i) The Director and Deputy

Director, Center for Drug Evaluation and

Research (CDER).

(ii) The Directors and Deputy

Directors of the Offices of Management,

Epidemiology and Biostatistics,

Compliance, Drug Evaluation I, Drug

Evaluation II, Research Resources,

Generic Drugs, and Over-the-Counter

Drug Evaluation, CDER.

(iii) The Chief and Freedom of

Information Officers, Freedom of

Information Staff, Office of

Management, CDER.

(iv) The Director, Division of

Management and Budget, Office of

Management, CDER.

(v) The Directors of the Divisions of

Drug Labeling Compliance, Drug

Quality Evaluation, Manufacturing and

Product Quality, and Scientific

Investigations, Office of Compliance,

CDER.

(14)(i) Regional Food and Drug

Directors.

(ii) District Directors.

(iii) The Director, St. Louis Branch.

(iv) The Director, New York

Laboratory Division, Northeast Region.

(v) The Director, Southeast Regional

Laboratory, Southeast Region.

(vi) The Director, National Forensic

Chemistry Center.

(b) * * *

(1) Deputy Commissioners.

(2) The Associate and Deputy

Associate Commissioners.

(3) The Director, Office of Human

Resources Management, Office of

Management.

* * * * *

Dated: May 9, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–12398 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Chlortetracycline Soluble Powder

Concentrate

AGENCY: Food and Drug Administration,

HHS.