[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32628-32629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15080]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0048]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Current Good Manufacturing Practice 
Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

DATES: Submit written comments on the collection of information by July 
16, 2001.

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: 
Wendy Taylor, 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 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 No. 0910-0154)--
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 at part 266 (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 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.
    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:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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   21 CFR           No. of         Annual Frequency      Total Annual          Hours per
   Section       Recordkeepers     of Recordkeeping         Records          Recordkeeper         Total Hours
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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

[[Page 32629]]

 
 
226.115             115                  10               1,150                   0.5               575
                                                                                             -------------------
  Total                                                                                         157,550
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\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.) is derived from agency records and experience.

    Dated: June 8, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15080 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-01-S