Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 44875-44876 [2016-16349]
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44875
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Information to Support a Claim of
Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Device’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400057 to
identify the guidance you are
requesting.
information in 21 CFR part 814, subpart
H have been approved under OMB
control number 0910–0332. The
collections of information in the
guidance document ‘‘Guidance for HDE
Holders, Institutional Review Boards
(IRBs), Clinical Investigators, and FDA
Staff—Humanitarian Device Exemption
(HDE) Regulation: Questions and
Answers’’ have been approved under
OMB control number 0910–0661.
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
[FR Doc. 2016–16350 Filed 7–8–16; 8:45 am]
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
IV. 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
21 CFR part 814 have been approved
under OMB control number 0910–0231.
The collections of information in 21
CFR part 807, subpart E have been
approved under OMB control number
0910–0120. The collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078. The collections of
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–N–0221; FDA–
2012–N–0559; FDA–2015–N–3287; FDA–
2015–N–3815; FDA–2007–D–0429; FDA–
2012–N–0447; FDA–2011–D–0597; FDA–
2011–D–0164; FDA–2013–N–0013; FDA–
2011–N–0146; FDA–2014–N–1533; FDA–
2011–N–0921; FDA–2015–N–2163]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
sradovich on DSK3GDR082PROD with NOTICES
Food Labeling: Notification Procedures for Statements on Dietary Supplements ..................................................
PHS Guideline on Infectious Disease Issues in Xenotransplantation ....................................................................
MDUFMA Small Business Qualification Certification ..............................................................................................
Electronic Submission of Medical Device Registration and Listing ........................................................................
Guidance for Industry on Q & A Regarding Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement & Nonprescription Drug Consumer
Protection Act .......................................................................................................................................................
Antimicrobial Animal Drug Distribution Reports and Recordkeeping ......................................................................
Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring .................
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic
Act ........................................................................................................................................................................
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ...........
Sanitary Transportation of Human and Animal Food ..............................................................................................
National Panel of Tobacco Consumer Studies .......................................................................................................
Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption ...............
Hearing, Aging, and Direct-to-Consumer Television Advertisements .....................................................................
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16349 Filed 7–8–16; 8:45 am]
BILLING CODE 4164–01–P
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Date approval
expires
0910–0331
0910–0456
0910–0508
0910–0625
6/30/2019
6/30/2019
6/30/2019
6/30/2019
0910–0641
0910–0659
0910–0733
6/30/2019
6/30/2019
6/30/2019
0910–0734
0910–0750
0910–0773
0910–0815
0910–0816
0910–0818
6/30/2019
6/30/2019
6/30/2019
6/30/2019
6/30/2019
6/30/2019
44876
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0242]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs
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 August 10,
2016.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0667 and
title ‘‘Current Good Manufacturing
Practice for Positron Emission
Tomography Drugs.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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.
SUMMARY:
sradovich on DSK3GDR082PROD with NOTICES
Current Good Manufacturing Practice
for Positron Emission Tomography
Drugs OMB Control Number 0910–
0667—Extension
Positron emission tomography is a
medical imaging modality involving the
use of a unique type of
radiopharmaceutical drug product.
FDA’s Current Good Manufacturing
Practice (CGMP) regulations at 21 CFR
part 212 are intended to ensure that
positron emission tomography (PET)
drug products meet the requirements of
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the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) regarding safety,
identity, strength, quality, and purity.
The CGMP requirements for PET drugs
are issued under the provisions of the
Food and Drug Administration
Modernization Act of 1997 (the
Modernization Act). These CGMP
requirements are designed to take into
account the unique characteristics of
PET drugs, including their short halflives, and the fact that most PET drugs
are produced at locations that are very
close to the patients to whom the drugs
are administered.
The CGMP regulations are intended to
ensure that approved PET drugs meet
the requirements of the FD&C Act as to
safety, identity, strength, quality, and
purity. The regulations address the
following matters: Personnel and
resources; quality assurance; facilities
and equipment; control of components,
in-process materials, and finished
products; production and process
controls; laboratory controls; acceptance
criteria; labeling and packaging controls;
distribution controls; complaint
handling; and recordkeeping.
The CGMP regulations establish
several recordkeeping requirements and
a third-party disclosure requirement for
the production of PET drugs. In making
our estimates of the time spent in
complying with these information
collection requirements, we relied on
informal communications we have had
with PET producers, visits by our staff
to PET facilities, and our familiarity
with both PET and general
pharmaceutical manufacturing
practices.
In the Federal Register of December
29, 2015 (80 FR 81332), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information and the estimated annual
burden for recordkeeping and third
party disclosure. In response to the
notice, FDA received several comments.
The comments raised a number of issues
that are discussed as follows.
(Comment 1) The comment disagreed
with FDA’s estimate that 129 PET drug
production facilities are required to
comply with part 212. Based on its
records, the comment said that
approximately 150 facilities are subject
to the PET CGMP requirements.
(Response) We have revised the
burden estimates to account for 150 PET
drug production facilities.
(Comment 2) The comment disagreed
with FDA’s statement in section I of the
December 29, 2015, Federal Register
notice, ‘‘Investigational and Research
PET Drugs.’’ The comment said that PET
facilities devote resources to comply
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with USP 32 Chapter 823, and that FDA
should estimate the recordkeeping
burden under USP 32 Chapter 823.
(Response) FDA agrees with the
comment that facilities incur a burden
to comply with USP 32 Chapter 823.
However, compliance with USP
provisions is beyond the scope of this
information collection, which only
pertains to the requirements under part
212.
(Comment 3) The comment said FDA
‘‘averages’’ the burden across different
categories of respondents and responses,
and that this approach results in lower
burden estimates. For example, the
comment said that most recordkeeping
will continue to be with a paper-based
system and not an electronic system,
and that the costs are different for each
system. In addition, there are
differences between the costs incurred
by commercial and academic facilities.
(Response) All commercial PET drug
facilities are currently utilizing
electronic records for recordkeeping as
well as paper-based records.
Commercial PET drug manufacturers
comprise approximately 90 percent of
the manufacturing sites. Many academic
PET facilities still use paper-based
records. However, academic PET sites
produce fewer batches for clinical use
compared to commercial sites, and have
fewer records. Sufficient resources and
personnel are needed to perform the
PET drug production activities, and
academic PET drug sites limited in
personnel and resources do bear more of
the regulatory burden. After a firm’s
recordkeeping process is established,
the burdens are generally the same for
entering records into an electronic
system or a paper-based system. We
question whether it is worthwhile to
prepare separate estimates for
commercial versus academic sites
because academic sites are a small
percentage of the total. Also, providing
an average estimate is consistent with
PRA requirements and, based on our
calculations, the number of academic
sites that apply for drug applications
represents a small percentage.
(Comment 4) The comment
questioned FDA’s methodology for
determining the burden estimates,
especially in table 2 where the actual
burden may be underestimated ‘‘by a
factor of 10 to 100.’’
(Response) In estimating the time to
comply with these information
collection requirements, we relied on
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]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44875-44876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16349]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-N-0221; FDA-2012-N-0559; FDA-2015-N-3287; FDA-
2015-N-3815; FDA-2007-D-0429; FDA-2012-N-0447; FDA-2011-D-0597; FDA-
2011-D-0164; FDA-2013-N-0013; FDA-2011-N-0146; FDA-2014-N-1533; FDA-
2011-N-0921; FDA-2015-N-2163]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Food Labeling: Notification Procedures 0910-0331 6/30/2019
for Statements on Dietary Supplements..
PHS Guideline on Infectious Disease 0910-0456 6/30/2019
Issues in Xenotransplantation..........
MDUFMA Small Business Qualification 0910-0508 6/30/2019
Certification..........................
Electronic Submission of Medical Device 0910-0625 6/30/2019
Registration and Listing...............
Guidance for Industry on Q & A Regarding 0910-0641 6/30/2019
Labeling of Nonprescription Human Drug
Products Marketed Without an Approved
Application as Required by the Dietary
Supplement & Nonprescription Drug
Consumer Protection Act................
Antimicrobial Animal Drug Distribution 0910-0659 6/30/2019
Reports and Recordkeeping..............
Guidance for Industry on Oversight of 0910-0733 6/30/2019
Clinical Investigations: A Risk-Based
Approach to Monitoring.................
Guidance for Industry on Safety Labeling 0910-0734 6/30/2019
Changes; Implementation of the Federal
Food, Drug, and Cosmetic Act...........
Accreditation of Third Party 0910-0750 6/30/2019
Certification Bodies to Conduct Food
Safety Audits and Issue Certifications.
Sanitary Transportation of Human and 0910-0773 6/30/2019
Animal Food............................
National Panel of Tobacco Consumer 0910-0815 6/30/2019
Studies................................
Standards for the Growing, Harvesting, 0910-0816 6/30/2019
Packaging, and Holding of Produce for
Human Consumption......................
Hearing, Aging, and Direct-to-Consumer 0910-0818 6/30/2019
Television Advertisements..............
------------------------------------------------------------------------
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16349 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P
