Browse: Departments   Dates   Agencies  

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. 2007N-0306]

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles

DATES: Fax written comments on the collection of information by January 2, 2008.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

SUMMARY: Agency information collection activities; proposals, submissions, and approvals,

SUPPLEMENTAL INFORMATION

In compliance with 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 Articles21 CFR Part 226 (OMB Control Number 09100154)Extension

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 cGMPs for Type A medicated articles have been codified under 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 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 under 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 article's claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the act.

In the Federal Register of August 16, 2007 (72 FR 46087), FDA published a 60day notice soliciting public comment on the proposed collection of information provisions. 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:
[[Page 67942]]
Table 1.Estimated Annual Recordkeeping Burden\1\ No. of Annual Frequency of Total Annual Hours per 21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total 226.42 115 260 29,000 0.75 22,425 226.58 115 260 29,000 1.75 52,325 226.80 115 260 29,000 0.75 22,425 226.102 115 260 24,000 1.75 52,325 226.110 115 260 29,000 0.25 7,475 226.115 115 10 1,150 0.5 575 Total 157,550 \1\There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the time 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: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E723351 Filed 113007; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Denver Presley Jr., Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271472.