[Federal Register: November 10, 2004 (Volume 69, Number 217)]
[Notices]               
[Page 65200-65201]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no04-119]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0244]

 
Agency Information Collection Activities: Submission for Office 
of Management and Budget Review; Comment Request, Current Good 
Manufacturing Practice Regulations for Type A Medicated Articles

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
December 10, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (PRA) (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 226 (OMB Control No. 0910-0154) Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351) (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 cGMP`s 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. Under 21 CFR 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 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.
    In the Federal Register of June 4, 2004 (69 FR 31615), the FDA 
published a 60-day notice, soliciting comment on the collection of 
information requirements. 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 65201]]



                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     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
----------------------------------------------------------------------------------------------------------------
226.102                          115                260             24,000               1.75             52,325
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226.110                          115                260             29,000               0.25              7,475
----------------------------------------------------------------------------------------------------------------
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.

    Dated: November 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24993 Filed 11-9-04; 8:45 am]

BILLING CODE 4160-01-S