[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39092-39093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19312]
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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.
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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 (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
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Annual
21 CFR Section No. of Recordkeepers Frequency per Total Annual Hours per Total Hours
Recordkeeping Records Recordkeeper
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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
[[Page 39093]]
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
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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 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
