[Federal Register: February 9, 2001 (Volume 66, Number 28)]
[Notices]
[Page 9706-9707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe01-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0048]
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
(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 written or electronic comments on the collection of
information by April 10, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 reinstatement 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: (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 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 CGMP's for Type A medicated articles
have been codified in 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
[[Page 9707]]
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 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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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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226.42 115 260 29,900 0.75 22,425
226.58 115 260 29,900 1.75 52,325
226.80 115 260 29,900 0.75 52,325
226.102 115 260 29,900 1.75 52,325
226.110 115 260 29,900 0.25 7,475
226.115 115 10 1,150 0.5 575
Total 187,450
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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: February 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3348 Filed 2-8-01; 8:45 am]
BILLING CODE 4160-01-F