[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41596-41597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Current Good 
Manufacturing Practice Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 10, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0154. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 (FD&C 
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 cGMPs for Type A medicated articles have 
been codified in part 226 (21 CFR part 226). Type A medicated articles 
that 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.
    In the Federal Register of February 21, 2020 (85 FR 10170), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41597]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
        21 CFR section             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  0.25 (15                   4,225
 of distribution records (for                                                    minutes).
 2 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.
                               ---------------------------------------------------------------------------------
    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: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14796 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P


