[Federal Register: December 3, 2007 (Volume 72, Number 231)]
[Notices]
[Page 67941-67942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de07-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0306]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 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.
DATES: Fax written comments on the collection of information by January
2, 2008.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0154. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of the
Chief Information Officer (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 Number 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 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 60-day 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\
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No. of Annual Frequency of Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total
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226.42 115 260 29,000 0.75 22,425
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226.58 115 260 29,000 1.75 52,325
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226.80 115 260 29,000 0.75 22,425
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226.102 115 260 24,000 1.75 52,325
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226.110 115 260 29,000 0.25 7,475
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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.) are derived from agency records and experience.
Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23351 Filed 11-30-07; 8:45 am]
BILLING CODE 4160-01-S