[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Notices]
[Pages 46087-46089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16087]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0306]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practice Regulations for 
Type A Medicated Articles

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

[[Page 46088]]

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 extension 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 current good manufacturing practice (cGMP) regulations for Type A 
medicated articles.

DATES: Submit written or electronic comments on the collection of 
information by October 15, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
Submit written comments on the collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should 
be identified with the 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: 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 extension 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 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 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.
    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:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of       Annual Frequency  of     Total Annual         Hours per
                    21 CFR Section                       Recordkeepers        Recordkeeping          Records          Recordkeeper           Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42                                                               115                   260             29,000                0.75             22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.58                                                               115                   260             29,000                1.75             52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.80                                                               115                   260             29,000                0.75             22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.102                                                              115                   260             24,000                1.75             52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.110                                                              115                   260             29,000                0.25              7,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.115                                                              115                    10              1,150                0.5                 575
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                           157,550
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 46089]]

    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: August 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16087 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S