[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6281-6283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01862]


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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, Agency, or we) 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 the collection of information regarding Type A Medicated Articles.

DATES: Either electronic or written comments on the collection of 
information must be submitted by April 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 3, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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, 240-402-7500.
     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

[[Page 6282]]

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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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) 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

    Section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 351), gives us the 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 are 
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. 
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.
    Description of Respondents: Manufacturers of Type A medicated 
articles.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
     21 CFR part; activity         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 non-
 drug), used in the
 manufacture of the medicated
 premixes.

[[Page 6283]]

 
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  0.25 (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: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01862 Filed 1-30-23; 8:45 am]
BILLING CODE 4164-01-P


