[Federal Register Volume 63, Number 3 (Tuesday, January 6, 1998)]
[Notices]
[Pages 564-565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 reinstatement 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 comments on the collection of information by 
March 9, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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 listed below.
    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 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 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 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 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.

[[Page 565]]

    The respondents for Type A medicated articles are pharmaceutical 
firms that manufacture human and veterinary drugs, veterinary drugs, 
and commercial feed mills.
    FDA estimate the burden of this collection of information as 
follows:

                                Table 1.--Estimated Annual Recordkeeping Burden1                                
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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                                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       
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: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-151 Filed 1-5-98; 8:45 am]
BILLING CODE 4160-01-F