Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 41596-41597 [2020-14796]
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41596
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER/FEEDERS) 1—Continued
Number of
recordkeepers
21 CFR section
Average
burden per
recordkeeper
Total annual
records
Total hours
225.180 requires identification, storage, and inventory
control of labeling in a manner that prevents label
mixups and assures that correct labels are used for
medicated feeds.
225.202 requires records of formulation, production,
and distribution of medicated feeds.
3,400
32
108,800
0.12 (7 minutes) ..
13,056
3,400
260
884,000
0.33 (20 minutes)
291,720
Total ........................................................................
........................
........................
........................
.............................
331,976
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects a
decrease of 65,265.20 hours. We
attribute this adjustment to a decrease in
the number of respondents for
Registered Licensed Commercial Feed
Mills. Medicated Feed Mill licensing is
voluntary. Firms may withdraw if they
go out of business or if they change the
source of the drug and a license is not
required.
Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14797 Filed 7–9–20; 8:45 am]
BILLING CODE 4164–01–P
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
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
records per
recordkeeper
VerDate Sep<11>2014
18:28 Jul 09, 2020
Jkt 250001
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
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\10JYN1.SGM
10JYN1
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
41597
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Total annual
responses
Average
burden per
response
Total hours
226.42; requires records be prepared and maintained for 2
years with respect to components (drug and nondrug)
used in the manufacture of the medicated premixes.
226.58; requires recordkeeping 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 of records for packaging
and labeling of Type A medicated articles.
226.102; requires maintenance of master-formula and
batch-production records for Type A medicated articles.
226.110; requires maintenance of distribution records (for
2 years) for each shipment of Type A medicated articles
for recall purposes.
226.115; requires maintenance of complaint files for Type
A medicated articles for 2 years.
65
260
16,900
0.75 (45 minutes).
12,675
65
260
16,900
1.75 ...............
29,575
65
260
16,900
12,675
65
260
16,900
0.75 (45 minutes).
1.75 ...............
65
260
16,900
65
10
650
Total ..............................................................................
........................
........................
........................
1 There
29,575
0.25 (15 minutes).
4,225
0.5 (30 minutes).
........................
325
89,050
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Purchased/Referred Care
Delivery Area Redesignation for the
Northwestern Band of the Shoshone
Nation
Indian Health Service, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
This Notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Northwestern Band of the Shoshone
Nation (NWBSN) in the State of Utah to
include the Utah counties of Box Elder,
Davis, Salt Lake, and Weber. The
current PRCDA for the NWBSN is Box
Elder County in the State of Utah. Tribal
members residing on the Fort Hall
Indian Reservation are provided health
services through the IHS direct care
facility in Fort Hall, Idaho, or by
Purchased/Referred Care (PRC) referrals
to private providers. NWBSN members
residing outside of the PRCDA are
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
18:28 Jul 09, 2020
Jkt 250001
eligible for direct care services,
however, they are not eligible for PRC
services. The sole purpose of this
expansion would be to authorize
additional Tribal members and
beneficiaries to receive PRC services.
DATES: Comments must be submitted
August 10, 2020.
ADDRESSES: In commenting, please refer
to FR Number 2020–14760. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Evonne Bennett, Acting
Director, Division of Regulatory and
Policy Coordination, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
09E70, Rockville, Maryland 20857.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above.
If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
CDR
John Rael, Director, Office of Resource
Access and Partnerships, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
10E85C, Rockville, Maryland 20857.
Telephone 301/443–0969 (This is not a
toll free number).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment.
Background: The IHS provides
services under regulations in effect as of
September 15, 1987, and republished at
42 CFR part 136, subparts A–C. Subpart
C defines a Contract Health Service
Delivery Area (CHSDA), now referred to
as a PRCDA, as the geographic area
within which PRC will be made
available by the IHS to members of an
identified Indian community who reside
in the PRCDA. Residence within a
PRCDA by a person who is within the
scope of the Indian health program, as
set forth in 42 CFR 136.12, creates no
legal entitlement to PRC but only
potential eligibility for services.
Services needed, but not available at an
IHS/Tribal facility, are provided under
the PRC program depending on the
availability of funds, the person’s
relative medical priority, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
The regulations at 42 CFR part 136,
subpart C, provide that, unless
otherwise designated, a PRCDA shall
consist of a county which includes all
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\10JYN1.SGM
10JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[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 (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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
