Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 6142-6143 [2011-2355]
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6142
Federal Register / Vol. 76, No. 23 / Thursday, February 3, 2011 / Notices
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.
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: Fax written comments on the
collection of information by March 7,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. 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.
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
SUMMARY:
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, Juanmanuel.vilela@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 (the
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 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.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of type A
medicated articles. The information
could also prove useful to FDA in
investigating product defects when a
drug is recalled. In addition, FDA 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 November
26, 2010 (75 FR 72827), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Annual frequency
per recordkeeping
Total annual
records
Hours per record
Total hours
226.42 ....................................................
226.58 ....................................................
226.80 ....................................................
226.102 ..................................................
226.110 ..................................................
226.115 ..................................................
115
115
115
115
115
115
260
260
260
260
260
10
29,900
29,900
29,900
29,900
29,900
1,150
.75
1.75
.75
1.75
.25
.5
22,425
52,325
22,425
52,325
7,475
575
Total ................................................
..............................
..............................
..............................
..............................
157,550
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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15:31 Feb 02, 2011
Jkt 223001
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03FEN1
Federal Register / Vol. 76, No. 23 / Thursday, February 3, 2011 / Notices
The estimate of the time required for
record preparation and maintenance is
based on Agency communications with
industry. Other information needed to
calculate the total burden hours (i.e.,
manufacturing sites, number of type A
medicated articles being manufactured,
etc.) are derived from Agency records
and experience.
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Angela Clarke, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8318;
e-mail: angela.clarke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
I. Background
FDA is announcing the availability of
a draft guidance for industry (#215)
entitled ‘‘Target Animal Safety and
Effectiveness Protocol Development and
Submission.’’ The purpose of this
document is to provide sponsors
guidance in preparation of study
protocols for review by the CVM,
ONADE, to reduce the time to protocol
concurrence. This guidance makes
recommendations to aid in the
preparation of protocols used to
generate data to support new animal
drug applications, specifically target
animal safety and substantial evidence
of effectiveness.
[FR Doc. 2011–2355 Filed 2–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0023]
Draft Guidance for Industry on ‘‘Target
Animal Safety and Effectiveness
Protocol Development and
Submission,’’ Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (#215) entitled ‘‘Target Animal
Safety and Effectiveness Protocol
Development and Submission.’’
The purpose of this document is to
provide sponsors guidance in
preparation of study protocols for
review by the Center for Veterinary
Medicine (CVM), Office of New Animal
Drug Evaluation (ONADE), to reduce the
time to protocol concurrence.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 19, 2011.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
jdjones on DSK8KYBLC1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:31 Feb 02, 2011
Jkt 223001
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB Control No. 0910–0032 (expiration
date 04/30/2011).
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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6143
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2315 Filed 2–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–1542; formerly
Docket No. 00D–0892]
Draft Guidance on Positron Emission
Tomography Drug Applications—
Content and Format for New Drug
Applications and Abbreviated New
Drug Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘PET Drug Applications—Content and
Format for NDAs and ANDAs.’’ The
draft guidance is intended to assist
manufacturers of certain positron
emission tomography (PET) drugs in
submitting new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs) in accordance
with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and FDA
regulations. This draft guidance revises
the draft guidance entitled ‘‘Draft
Guidance for Industry on the Content
and Format of New Drug Applications
and Abbreviated New Drug
Applications for Certain Positron
Emission Tomography Drug Products;
Availability,’’ issued on March 10, 2000.
Elsewhere in this issue of the Federal
Register, FDA is announcing a public
meeting to assist applicants in preparing
NDAs or ANDAs for fludeoxyglucose
(FDG) 18 injection, ammonia N 13
injection, and sodium fluoride F 18
injection used in PET imaging.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 4, 2011.
SUMMARY:
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6142-6143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2355]
[[Page 6142]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by March
7, 2011.
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 e-mailed to oira_submission@omb.eop.gov. 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.
FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@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 (the
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
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.
This information is needed so that FDA can monitor drug usage and
possible misformulation of type A medicated articles. The information
could also prove useful to FDA in investigating product defects when a
drug is recalled. In addition, FDA 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 November 26, 2010 (75 FR 72827), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual frequency Total annual
21 CFR Section recordkeepers per recordkeeping records Hours per record Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42................................................... 115 260 29,900 .75 22,425
226.58................................................... 115 260 29,900 1.75 52,325
226.80................................................... 115 260 29,900 .75 22,425
226.102.................................................. 115 260 29,900 1.75 52,325
226.110.................................................. 115 260 29,900 .25 7,475
226.115.................................................. 115 10 1,150 .5 575
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. ................. ................. 157,550
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 6143]]
The estimate of the time required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to calculate the total burden hours (i.e.,
manufacturing sites, number of type A medicated articles being
manufactured, etc.) are derived from Agency records and experience.
Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2355 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P
