[Federal Register: June 4, 2004 (Volume 69, Number 108)]
[Notices]               
[Page 31615-31617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn04-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0244]

 
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 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.

[[Page 31616]]


DATES: Submit written or electronic comments on the collection of 
information by August 3, 2004.

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.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 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 Management 
Programs (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 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 
act), 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 act (21 U.S.C. 
351(a)(2)(B). 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 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.
    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 Frequency     Total Annual     Hours per
    21 CFR Section      No. of Recordkeepers   of Recordkeeping       Records      Recordkeeper    Total Hours
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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.

    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.


[[Page 31617]]


    Dated: May 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12685 Filed 6-3-04; 8:45 am]

BILLING CODE 4160-01-S