[Federal Register Volume 66, Number 28 (Friday, February 9, 2001)]
[Notices]
[Pages 9706-9707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3348]


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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://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