65200 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 

The estimate of the time required for 

reporting requirements, record 

preparation and maintenance for this 

collection of information is based on 

agency communication with industry. 

Additional information needed to make 

a final calculation of the total burden 

hours (i.e. the number of respondents, 

the number of recordkeepers, the 

number of INAD applications received, 

etc.) is derived from agency records.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24991 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0481]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Food Additive Petitions

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Food Additive Petitions’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

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 the 

Federal Register of June 4, 2004 (69 FR 

31617), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0546. The 

approval expires on November 30, 2006. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24992 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0244]

Agency Information Collection 

Activities: Submission for Office of 

Management and Budget Review; 

Comment Request, Current Good 

Manufacturing Practice Regulations for 

Type A Medicated Articles

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: Fax written comments on the 

collection of information by December 

10, 2004.

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX 202–395–6974.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

4B–41, Rockville, MD 20857, 301–827–

1472.

SUPPLEMENTARY INFORMATION: In 

compliance with section 3507 of the 

Paperwork Reduction Act of 1995 (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 226 (OMB Control No. 

0910–0154) Extension

Under section 501 of the Federal 

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

351) (the act), 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 in 

part 226 (21 CFR part 226). Type A 

medicated articles which are not 

manufactured in accordance with these 

regulations are considered adulterated 

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

Under 21 CFR 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 assure 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 assure that their 

medicated articles meet the 

requirements of the act as to safety and 

also meet the articles, claimed identity, 

strength, quality and purity, as required 

by section 501(a)(2)(B) of the act as to 

safety and also meet the articles claimed 

identity, strength, quality, and purity, as 

required by section 501(a)(2)(B) of the 

act.

In the Federal Register of June 4, 2004 

(69 FR 31615), the FDA published a 60-

day notice, soliciting comment on the 

collection of information requirements. 

In response to that notice, no comments 

were received. The respondents for type 

A medicated articles are pharmaceutical 

firms that manufacture both human and 

veterinary drugs, those firms that 

produce only veterinary drugs and 

commercial feed mills.

FDA estimates the burden of this 

collection of information as follows: