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.
Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Rules and Regulations 26827

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by the

American Cyanamid Co. The

supplemental NADA provides for the

safe and effective use of

chlortetracycline bisulfate (CTC

bisulfate) soluble powder concentrate in

the drinking water of chickens and

turkeys for control of certain bacterial

diseases susceptible to CTC, in the

drinking water of swine, and as a

drench in cattle for control and

treatment of certain bacterial diseases

susceptible to CTC. The approved

supplemental NADA reflects

compliance with findings of the

National Academy of Sciences/National

Research Council (NAS/NRC), Drug

Efficacy Study Group’s (DESI)

evaluation of related drug products’

effectiveness and FDA’s conclusions

concerning that evaluation.

EFFECTIVE DATE: May 19, 1995.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: American

Cyanamid Co., Berdan Ave., Wayne, NJ

07470, is the sponsor of NADA 55–020

which provides for use of Aureomycin

CTC (bisulfate) Soluble Powder

Concentrate (available in 1/4 and 10

pound packets) containing CTC

bisulfate equivalent to 102.4 grams of

CTC hydrochloride (CTC HCl) per

pound. The drug product is used to

medicate the drinking water of

chickens, turkeys, swine, calves, beef

cattle, and nonlactating dairy cattle in

accordance with § 520.445b(d)(4) (21

CFR 520.445b(d)(4)). The NADA was

originally approved on June 7, 1963.

American Cyanamid Co. filed a

supplement to NADA 55–020 revising

the product labeling to conform to that

approved for the firm’s supplemental

NADA’s 65–071 (Aureomycin (CTC

HCl) Soluble Powder) and 65–440

(Aureomycin (CTC HCl) Soluble

Powder Concentrate). Approval of those

supplemental NADA’s was published in

the Federal Register of August 3, 1994

(59 FR 39438). The approval reflects

compliance of the products’ labeling

with NAS/NRC findings and FDA’s

concurrence with those findings.

The NAS/NRC evaluation is

concerned only with the drugs’

effectiveness and safety to the treated

animal. It does not take into account the

safety for food use of food derived from

drug-treated animals. Nothing herein

will constitute a bar to further

proceedings with respect to questions of

safety of the drug or its metabolites in

food products derived from treated

animals.

Supplemental NADA 55–020 is

approved as of April 6, 1995, and the

regulations are amended by revising

§ 520.445b(d)(4) to reflect the approval.

The basis for this approval is discussed

in the freedom of information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food producing animals

does not qualify for marketing

exclusivity because the supplemental

application does not contain reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) and new human food safety

studies (other than bioequivalence or

residue studies) essential to the

approval and conducted or sponsored

by the applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.445b is amended by

revising paragraph (d)(4) introductory

text to read as follows:

§ 520.445b Chlortetracycline powder

(chlortetracycline hydrochloride or

chlortetracycline bisulfate).

* * * * *

(d) * * *

(4) The following uses of

chlortetracycline hydrochloride or

chlortetracycline bisulfate in drinking

water or drench were reviewed by the

National Academy of Sciences/National

Research Council (NAS/NRC) and found

effective:

* * * * * *

Dated: May 4, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–12291 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

36 CFR Part 1258

RIN 3095–AA63

Reproduction Services; Fee Schedule

AGENCY: National Archives and Records

Administration (NARA).

ACTION: Final rule; confirmation of

interim final rule.

SUMMARY: The National Archives and

Records Administration (NARA) is

adopting as a final rule the interim final

rule on NARA reproduction fees. The

interim rule corrected addresses and

removed certain photographic

reproductions and fees from the

published fee schedule. This rule will

affect Federal agencies and members of

the public who order reproductions

from NARA.

EFFECTIVE DATE: The effective date of

this rule is March 6, 1995.

FOR FURTHER INFORMATION CONTACT:

Mary Ann Hadyka or Nancy Allard on

(301)713–6730.

SUPPLEMENTARY INFORMATION: On

January 30, 1995, NARA issued an

interim final rule. The effective date of

the interim final rule was March 6,

1995. No comments were received

during the 60-day comment period

provided by the interim rule. Therefore,

we are confirming in this final rule the

correction of addresses and removal of

published fees for certain reproductions

in 36 CFR part 1258.

This rule is not a significant

regulatory action for purposes of

Executive Order 12866 of September 30,