59718 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Rules and Regulations

List of Subjects in 21 CFR Part 73

Color additives, Cosmetics, Drugs,

Foods, Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321,

341, 342, 343, 348, 351, 352, 355, 361,

362, 371, 379e) and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10), notice is given

that no objections or requests for a

hearing were filed in response to the

July 6, 2000, final rule. Accordingly, the

amendments issued thereby became

effective August 8, 2000.

Dated: September 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25703 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. 97N–0165]

Regulations Requiring Manufacturers

to Assess the Safety and Effectiveness

of New Drugs and Biological Products

in Pediatric Patients; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

biologics regulations to reincorporate a

regulation that was inadvertently

omitted. This action is being taken to

improve the accuracy of the regulations.

DATES: This rule is effective October 6,

2000.

FOR FURTHER INFORMATION CONTACT:

Stephen M. Ripley, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: FDA has

discovered that an error has caused an

omission in the agency’s codified

regulations for part 601 (21 CFR part

601). In the Federal Register of May 17,

1999 (64 FR 26657), FDA published a

final rule that inadvertently omitted

§ 601.37 when subpart D was revised.

Accordingly, § 601.37, which was added

in the Federal Register of December 2,

1998 (63 FR 66672), is being

reincorporated into the regulations and

redesignated as § 601.28. In addition,

FDA is removing subpart B and

reorganizing subpart C in part 601.

Accordingly, current § 601.28 is

redesignated as § 601.15. This document

corrects those errors. Publication of this

document constitutes final action under

the Administrative Procedure Act (5

U.S.C. 553). FDA has determined that

notice and public comment are

unnecessary because this amendment is

nonsubstantive.

List of Subjects in 21 CFR Part 601

Administrative practice and

procedure, Biologics, Confidential

business information.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR part 601 is amended

as follows:

PART 601—LICENSING

1. The authority citation for 21 CFR

part 601 continues to read as follows:

Authority: 15 U.S.C. 1451–1561; 21 U.S.C.

321, 351, 352, 353, 355, 360, 360c–360f,

360h–360j, 371, 374, 379e, 381; 42 U.S.C.

216, 241, 262, 263; sec. 122, Pub. L. 105–115,

111 Stat. 2322 (21 U.S.C. 355 note).

§ 601.12 [Redesignated to subpart C]

2. Section 601.12 Changes to an

approved application is redesignated

from subpart B to subpart C.

Subpart B [Removed and Reserved]

3. Subpart B is removed and reserved.

Subpart C—Biologics Licensing

4. The heading for subpart C is

revised to read as set forth above.

§ 601.28 [Redesignated as § 601.15]

5. Section 601.28 is redesignated as

§ 601.15 in subpart C, and a new

§ 601.28 is added to subpart C to read

as follows:

§ 601.28 Annual reports of postmarketing

pediatric studies.

Sponsors of licensed biological

products shall submit the following

information each year within 60 days of

the anniversary date of approval of the

license to the Director, Center for

Biologics Evaluation and Research:

(a) Summary. A brief summary stating

whether labeling supplements for

pediatric use have been submitted and

whether new studies in the pediatric

population to support appropriate

labeling for the pediatric population

have been initiated. Where possible, an

estimate of patient exposure to the drug

product, with special reference to the

pediatric population (neonates, infants,

children, and adolescents) shall be

provided, including dosage form.

(b) Clinical data. Analysis of available

safety and efficacy data in the pediatric

population and changes proposed in the

labeling based on this information. An

assessment of data needed to ensure

appropriate labeling for the pediatric

population shall be included.

(c) Status reports. A statement on the

current status of any postmarketing

studies in the pediatric population

performed by, or on behalf of, the

applicant. The statement shall include

whether postmarketing clinical studies

in pediatric populations were required

or agreed to, and if so, the status of these

studies, e.g., to be initiated, ongoing

(with projected completion date),

completed (including date), completed

and results submitted to the biologics

license application (including date).

Dated: September 29, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25705 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Part 4

[T.D. ATF–431; Ref: Notice Nos. 890 and

895]

RIN: 1512–AB86

Labeling of Flavored Wine Products

(98R–317P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Final rule, Treasury decision.

SUMMARY: The Bureau of Alcohol,

Tobacco and Firearms (ATF) is

amending the regulations to prohibit the

use of any varietal designation, type

designation of varietal significance,

semi-generic geographic type

designation, or geographic distinctive

designation in statements of

composition for flavored wines and

other wine specialty products. The

regulations are also being amended to

provide that references on labels to such

designations in the brand name, product

name, or fanciful name are limited to

standard grape wines. ATF believes that

the final regulations will ensure that

consumers are not misled as to the

identity of the products they purchase.