[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72827-72829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29687]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0598]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for manufacturers of type A medicated articles.
DATES: Submit either electronic or written comments on the collection
of information by January 25, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets
[[Page 72828]]
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
FD&C 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 in 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 FD&C 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 FD&C 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 FD&C 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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Annual
No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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21 CFR Section:
226.42...................... 115 260 29,900 .75 22,425
226.58...................... 115 260 29,900 1.75 52,325
226.80...................... 115 260 29,900 .75 22,425
226.102..................... 115 260 29,900 1.75 52,325
226.110..................... 115 260 29,900 .25 7,475
226.115..................... 115 10 1,150 .5 575
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.............. .............. .............. .............. 157,550
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 72829]]
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
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manufactured, etc.) are derived from Agency records and experience.
Dated: November 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29687 Filed 11-24-10; 8:45 am]
BILLING CODE 4160-01-P