[Federal Register Volume 72, Number 231 (Monday, December 3, 2007)]
[Notices]
[Pages 67941-67942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23351]


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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 [email protected]. 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