39092 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

presentation on early warning from

representatives of the Advisory Council

on Governmental Audit Standards.

Any interested person may attend the

meeting as an observer. Board

discussions and reviews are open to the

public.

FOR FURTHER INFORMATION CONTACT:

Wendy Comes, Executive Director, 441

G St., NW., Room 3B18, Washington, DC

20548, or call (202) 512–7350.

Authority: Federal Advisory Committee

Act. Pub. L. No. 92–463, Section 10(a)(2), 86

Stat. 770, 774 (1972) (current version at 5

U.S.C. app. section 10(a)(2) (1988); 41 CFR

101–6.1015 (1990).

Dated: July 16, 1998.

Wendy M. Comes,

Executive Director.

[FR Doc. 98–19417 Filed 7–20–98; 8:45 am]

BILLING CODE 1610–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Citizens Advisory Committee on Public

Health Service Activities and Research

at Department of Energy Sites: Notice

of Charter Renewal

This gives notice under the Federal

Advisory Committee Act (Public Law

92–463) of October 6, 1972, that the

Citizens Advisory Committee on Public

Health Service Activities and Research

at Department of Energy Sites of the

Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services, has been renewed

for a 2-year period beginning July 7,

1998 through July 7, 2000.

For further information, contact the

Management Analysis and Services

Office, Committee Management and

Program Panels Activity, CDC, Mailstop

E–72, 1600 Clifton Road, NE, Atlanta,

Georgia 30333, telephone 404–639–6389

or fax 404–639–6290.

Dated: July 13, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–19326 Filed 7–20–98; 8:45 am]

BILLING CODE 4861–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0515]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by August 20,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Current Good Manufacturing Practice

Regulations for Type A Medicated

Articles—(21 CFR Part 226)—(OMB

Control Number 0910–0154—

Reinstatement)

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (CGMP)

regulations for drugs, including Type A

medicated articles. A Type A medicated

article is a feed product containing a

concentrated drug diluted with a feed

carrier substance. A Type A medicated

article is intended solely for use in the

manufacture of another Type A

medicated article or a Type B or Type

C medicated feed. Medicated feeds are

administered to animals for the

prevention, cure, mitigation, or

treatment of disease or for growth

promotion and feed efficiency.

Statutory requirements for CGMP’s for

Type A medicated articles have been

codified under part 226 (21 CFR part

226). Type A medicated articles that are

not manufactured in accordance with

these regulations are considered

adulterated under section 501(a)(2)(B) of

the act. Under part 226, a manufacturer

is required to establish, maintain, and

retain records for Type A medicated

articles, including records to document

procedures required under the

manufacturing process to ensure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e., batch and stability testing),

and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of Type A medicated

articles. The information could also

prove useful to FDA in investigating

product defects when a drug is recalled.

In addition, FDA will use the CGMP

criteria in part 226 to determine

whether or not the systems used by

manufacturers of Type A medicated

articles are adequate to ensure that their

medicated articles meet the

requirements of the act pertaining to

safety and also meet the articles,

claimed identity, strength, quality and

purity, as required by section

501(a)(2)(B) of the act.

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture both human and

veterinary drugs and commercial feed

mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 200 120 24,000 0.75 18,000

226.58 200 120 24,000 1.75 42,000

226.80 200 120 24,000 0.75 18,000

226.102 200 120 24,000 1.75 42,000
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39093

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.110 200 120 24,000 0.25 6,000

226.115 200 120 24,000 1.00 24,000

Total burden hours 150,000

1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: July 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19312 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0546]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food And Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by August 20,

1998.

ADDRESSES: Submit written comments

on the proposed collection of

information to the Office of Information

and Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following collection of

information to OMB for review and

clearance.

Food Labeling Regulations (21 CFR

Parts 101, 102, 104, and 105)

FDA regulations in parts 101, 102,

104, and 105 (21 CFR parts 101, 102,

104, and 105) require food producers to

disclose to consumers and others

specific information about themselves

or their products on the label or labeling

of their products. Certain of these

regulations also require that food

producers retain records establishing

the basis for the information contained

in the label or labeling of their products

and provide those records to regulatory

officials. Finally, certain regulations

provide for submissions of information

to FDA in the form of petitions or

notices. These regulations were issued

under the authority of sections 4, 5, and

6 of the Fair Packaging and Labeling Act

(FPLA) (15 U.S.C. 1453, 1454, and 1455)

and of sections 201, 301, 402, 403, 409,

411, 701, and 721 of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 321, 331, 342, 343, 348, 350, 371,

and 379e). Most of these regulations

derive from section 403 of the act,

which provides that a food product

shall be misbranded if, among other

things, its label or labeling fails to bear

certain required information concerning

the food product, is false or misleading

in any particular, or bears certain types

of unauthorized claims. The disclosure

requirements and other collections of

information in the regulations in parts

101, 102, 104, and 105 are necessary to

ensure that food products sold in the

United States are in compliance with

the labeling provisions of the act and

the FPLA. One purpose of this

submission to OMB under the PRA is to

consolidate all of the information

collection provisions in these

regulations into one submission to OMB

for its review and approval.

Section 101.3 of FDA’s food labeling

regulations requires that the label of a

food product in packaged form bear a

statement of identity (i.e., the name of

the product), including, as appropriate,

the form of the food or the name of the

food imitated. Section 101.4 prescribes

the requirements for the declaration of

ingredients on the label or labeling of

food products in packaged form. Section

101.5 requires that the label of a food

product in packaged form specify the

name and place of business of the

manufacturer, packer, or distributor

and, if the food producer is not the

manufacturer of the food product, its

connection with the food product.

Section 101.9 requires that nutrition

information be provided for all food

products intended for human

consumption and offered for sale, unless

an exemption in § 101.9(j) applies to the

product. Section 101.9(g)(9) provides for

the submission to FDA of requests for

alternative approaches to nutrition

labeling. Finally, § 101.9(j)(18) provides

for the submission to FDA of notices

from firms claiming the small business

exemption from nutrition labeling.

Section 101.10 requires that restaurants

provide nutrition information, upon

request, for any food or meal for which

a nutrient content claim or health claim

is made. Section 101.12(e) provides that

a manufacturer that adjusts the

reference amount customarily

consumed (RACC) of an aerated food for

the difference in density of the aerated

food relative to the density of the

appropriate nonaerated reference food

must be prepared to show FDA detailed

protocols and records of all data that

were used to determine the densityadjusted RACC. Section 101.12(g)

requires that the label or labeling of a

food product disclose the serving size

that is the basis for a claim made for the

product if the serving size on which the

claim is based differs from the RACC.

Section 101.12(h) provides for the

submission of petitions to FDA to

request changes in the reference

amounts defined by regulation.

Section 101.13 requires that nutrition

information be provided in accordance

with the provisions of § 101.9 for any

food product for which a nutrient

content claim is made. Under some

circumstances, § 101.13 also requires

the disclosure of other types of

information as a condition for the use of

a nutrient content claim. For example,

under § 101.13(j), if the claim compares