82 FR 32834 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

The Food and Drug Administration (FDA or we) 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.

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32834-32835]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14996]


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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, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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: Fax written comments on the collection of information by August 
17, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0154. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 32835]]


FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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 (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 assure 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. 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.
    In the Federal Register of October 17, 2016 (81 FR 71513), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comment. FDA estimates the 
burden of this collection of information as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                Noumber of
               21 CFR section                    Number of      records per    Total annual        Average burden per  recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
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226.42, requires records be prepared and                  65             260          16,900  0.75 (45 minutes).........................          12,675
 maintained for 2 years with respect to
 components (drug and non-drug) used in the
 manufacture of the medicated premixes.
226.58, requires recordkeeping for                        65             260          16,900  1.75......................................          29,575
 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 of records for               65             260          16,900  0.75 (45 minutes).........................          12,675
 packaging and labeling of Type A medicated
 articles.
226.102, requires maintenance of master-                  65             260          16,900  1.75......................................          29,575
 formula and batch-production records for
 Type A medicated articles.
226.110, requires maintenance of                          65             260          16,900  .25 (15 minutes)..........................           4,225
 distribution records (2 years) for each
 shipment of Type A medicated articles for
 recall purposes.
226.115, requires maintenance of complaint                65              10             650  .5 (30 minutes)...........................             325
 files for Type A medicated articles for 2
 years.
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    Total...................................  ..............  ..............  ..............  ..........................................         76, 375
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We based our estimate of the time required for record preparation 
and maintenance on our communications with industry. We derived 
additional information needed to calculate the total burden hours 
(i.e., manufacturing sites, number of Type A medicated articles being 
manufactured, etc.) from our records and experience. The burden has not 
changed since the last OMB approval.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14996 Filed 7-17-17; 8:45 am]
 BILLING CODE 4164-01-P