[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10170-10171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03463]



[[Page 10170]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0598]


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 Type A 
Medicated Articles.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 21, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0598 for ``Current Good Manufacturing Practice Regulations 
for Type A Medicated Articles.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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)

[[Page 10171]]

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 (21 
U.S.C. 351) (the FD&C 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 cGMPs 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 FD&C Act (21 
U.S.C. 351(a)(2)(B). 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.
    The required records are used by both the respondents and FDA. The 
records are used by manufacturers of Type A medicated articles to 
verify that appropriate control measures have been maintained, or that 
appropriate corrective actions were taken if the control measures were 
not maintained. Such verification activities are essential to ensure 
that the cGMP system is working as planned. We review the records 
during the conduct of periodic plant inspections. This information is 
needed so that we can monitor drug usage and possible misformulation of 
Type A medicated articles. The information could also prove useful to 
us in investigating product defects when a drug is recalled. In 
addition, we 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 FD&C 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 FD&C Act.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                   Number of
          21 CFR part              Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
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226.42; requires records be                 65             260          16,900  0.75 (45                  12,675
 prepared and maintained for 2                                                   minutes).
 years with respect to
 components (drug and
 nondrug), used in the
 manufacture of the medicated
 premixes.
226.58; requires recordkeeping              65             260          16,900  1.75............          29,575
 for establishment of
 laboratory controls to ensure
 that adequate specifications
 and test procedures for the
 drug components and Type A
 medicated articles conform to
 appropriate standards of
 identity, strength, quality
 and purity.
226.80; requires maintenance                65             260          16,900  0.75 (45                  12,675
 of records for packaging and                                                    minutes).
 labeling of Type A medicated
 articles.
226.102; requires maintenance               65             260          16,900  1.75............          29,575
 of master-formula and batch-
 production records for Type A
 medicated articles.
226.110; requires maintenance               65             260          16,900  0.025 (15                  4,225
 of distribution records (2                                                      minutes).
 years), for each shipment of
 Type A medicated articles for
 recall purposes.
226.115; requires maintenance               65              10             650  0.5 (30 minutes)             325
 of complaint files for Type A
 medicated articles for 2
 years.
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    Total.....................  ..............  ..............  ..............  ................          89,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03463 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P


