[Federal Register: June 15, 2001 (Volume 66, Number 116)]
[Notices]
[Page 32628-32629]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn01-72]
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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
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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