[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
