[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39092-39093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0515]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

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: Submit written comments on the collection of information by 
August 20, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

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: In compliance with section 3507 of the 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 Part 226)--(OMB Control Number 0910-
0154--Reinstatement)

    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 under 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 required to establish, maintain, and retain 
records for Type A medicated articles, including records to document 
procedures required under the manufacturing process to ensure 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 ensure that their medicated articles meet the 
requirements of the act pertaining 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 and commercial 
feed mills.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1.--Estimated Annual Recordkeeping Burden<SUP>1                                
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                                                  Annual                                                        
  21 CFR Section      No. of Recordkeepers     Frequency per   Total Annual      Hours per        Total Hours   
                                               Recordkeeping      Records      Recordkeeper                     
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226.42              200                           120          24,000               0.75           18,000       
226.58              200                           120          24,000               1.75           42,000       
226.80              200                           120          24,000               0.75           18,000       
226.102             200                           120          24,000               1.75           42,000       

[[Page 39093]]

                                                                                                                
226.110             200                           120          24,000               0.25            6,000       
226.115             200                           120          24,000               1.00           24,000       
Total burden hours                                                                                150,000       
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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 times 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: July 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19312 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F