Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance, 81550-81551 [2015-32781]
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Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10415]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by January 29, 2016.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
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SUMMARY:
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3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Generic
Clearance for the Collection Customer
Satisfaction Surveys; Use: This
collection of information is necessary to
enable the Agency to garner customer
and stakeholder feedback in an efficient,
timely manner, in accordance with our
commitment to improving service
delivery. The information collected
from our customers and stakeholders
will help ensure that users have an
effective, efficient, and satisfying
experience with the Agency’s programs.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Collecting voluntary customer
feedback is the least burdensome, most
effective way for the Agency to
determine whether or not its public Web
sites are useful to and used by its
customers. Generic clearance is needed
to ensure that the Agency can
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continuously improve its Web sites
though regular surveys developed from
these pre-defined questions. Surveying
the Agency Web sites on a regular,
ongoing basis will help ensure that
users have an effective, efficient, and
satisfying experience on any of the Web
sites, maximizing the impact of the
information and resulting in optimum
benefit for the public. The surveys will
ensure that this communication channel
meets customer and partner priorities,
builds the Agency’s brands, and
contributes to the Agency’s health and
human services impact goals. Note that
the burden estimate for the collection
has increased from the figure published
in the 60-day notice (80 FR 66904). In
the 60-day notice, we did not account
for the currently approved burden that
will be retained and then add it to the
new burden for which we are seeking
approval. The total is now 50,000 hours.
Form Number: CMS–10415 (OMB
control number: 0938–1185); Frequency:
Occasionally; Affected Public:
Individuals and Households, Business
or other for-profits and Not-for-profit
institutions, State, Local or Tribal
Governments; Number of Respondents:
1,000,000; Total Annual Responses:
1,000,000; Total Annual Hours: 50,000.
(For policy questions regarding this
collection contact John Booth at 410–
786–6577.)
Dated: December 22, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–32633 Filed 12–29–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0434]
Acidified Foods; Draft Guidance for
Industry; Withdrawal of Draft Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA or we) is
announcing the withdrawal of a draft
guidance for industry, entitled ‘‘Draft
Guidance for Industry: Acidified
Foods.’’ The draft guidance was
intended to complement our regulations
regarding acidified foods (including
regulations for specific current good
manufacturing practice, establishment
registration, and process filing) by
helping commercial food processors
SUMMARY:
E:\FR\FM\30DEN1.SGM
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices
determine whether their food products
are subject to these regulations by
providing for voluntary submission of
process filings by processors of nonacidified foods (e.g., some acid foods or
fermented foods), and by helping
processors of acidified foods in ensuring
safe manufacturing, processing, and
packing processes and in employing
appropriate quality control procedures.
We are withdrawing the draft guidance,
in part, because many of the topics
addressed in the draft guidance are now
being addressed in other documents.
DATES: The withdrawal is effective
December 30, 2015.
FOR FURTHER INFORMATION CONTACT:
Michael Mignogna, Center for Food
Safety and Applied Nutrition (HFS–
302), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–1565.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
September 27, 2010 (75 FR 59268), we
announced the availability of a draft
guidance entitled ‘‘Draft Guidance for
Industry: Acidified Foods’’ and gave
interested parties an opportunity to
submit comments by December 27,
2010, for us to consider before
beginning work on the final version of
the guidance. The draft guidance was
intended to complement our regulations
regarding acidified foods (including
regulations for specific current good
manufacturing practice (21 CFR part
114), establishment registration (21 CFR
108.25(c)(1)), and process filing (21 CFR
108.25(c)(2)) by helping commercial
food processors in determining whether
their food products are subject to these
regulations and by providing for
voluntary submission of process filings
by processors who conclude that their
products are non-acidified foods (e.g.,
acid foods or fermented foods). The
draft guidance also was intended to help
processors of acidified foods in ensuring
safe manufacturing, processing, and
packing processes and in employing
appropriate quality control procedures.
We are withdrawing the draft
guidance, in part, because the
procedures for voluntary submission of
process filings by processors of nonacidified foods are addressed by our
recently issued guidance entitled
‘‘Submitting Form FDA 2541 (Food
Canning Establishment Registration)
and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food
Process Filing Forms) to FDA in
Electronic or Paper Format’’ (80 FR
60909, October 8, 2015). We also are
withdrawing the draft guidance, in part,
because we recently issued a final rule
entitled ‘‘Current Good Manufacturing
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17:59 Dec 29, 2015
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Practice, Hazard Analysis, and RiskBased Preventive Controls for Human
Food’’ (80 FR 55908, September 17,
2015), and that rule, along with
guidance documents we are developing
as a companion to that rule, should help
processors in ensuring safe
manufacturing, processing, and packing
processes and in employing appropriate
quality control procedures.
Dated: December 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32781 Filed 12–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
January meeting, the Advisory Council
will review the process for developing
recommendations and developing the
National Plan to Address Alzheimer’s
Disease, discuss updates to work on
Goals 2 and 3 of the National Plan, and
hear updates on a future summit on
care.
DATES: The meeting will be held on
January 25, 2016 from 9:30 a.m. to 5:00
p.m. EDT.
ADDRESSES: The meeting will be held in
Room 6, Building 31 of the National
Institutes of Health, 9000 Rockville
Pike, Bethesda, Maryland 20892.
Comments: Time is allocated in the
afternoon on the agenda to hear public
comments. The time for oral comments
will be limited to two (2) minutes per
individual. In lieu of oral comments,
formal written comments may be
submitted for the record to Rohini
Khillan, ASPE, 200 Independence
Avenue SW., Room 424E, Washington,
DC 20201. Comments may also be sent
to napa@hhs.gov. Those submitting
written comments should identify
themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Rohini Khillan (202) 690–5932,
SUMMARY:
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81551
rohini.khillan@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘January 25
Meeting Attendance’’ in the Subject line
by Friday, January 15, so that their
names may be put on a list of expected
attendees and forwarded to the security
officers at the National Institutes of
Health. Any interested member of the
public who is a non-U.S. citizen should
include this information at the time of
registration to ensure that the
appropriate security procedure to gain
entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting:
During the January meeting, the
Advisory Council will review the
process for developing
recommendations and developing the
National Plan to Address Alzheimer’s
Disease, discuss updates to work on
Goals 2 and 3 of the National Plan, and
hear updates on a future summit on
care.
Procedure and Agenda: This meeting
is open to the public. Please allow 45
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section
2(e)(3) of the National Alzheimer’s
Project Act. The panel is governed by
provisions of Public Law 92–463, as
amended (5 U.S.C. Appendix 2), which
sets forth standards for the formation
and use of advisory committees.
Dated: December 21, 2015.
Richard G. Frank,
Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2015–32890 Filed 12–29–15; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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]]>Agencies
[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81550-81551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32781]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0434]
Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft
Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal of a draft guidance for industry, entitled ``Draft Guidance
for Industry: Acidified Foods.'' The draft guidance was intended to
complement our regulations regarding acidified foods (including
regulations for specific current good manufacturing practice,
establishment registration, and process filing) by helping commercial
food processors
[[Page 81551]]
determine whether their food products are subject to these regulations
by providing for voluntary submission of process filings by processors
of non-acidified foods (e.g., some acid foods or fermented foods), and
by helping processors of acidified foods in ensuring safe
manufacturing, processing, and packing processes and in employing
appropriate quality control procedures. We are withdrawing the draft
guidance, in part, because many of the topics addressed in the draft
guidance are now being addressed in other documents.
DATES: The withdrawal is effective December 30, 2015.
FOR FURTHER INFORMATION CONTACT: Michael Mignogna, Center for Food
Safety and Applied Nutrition (HFS-302), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1565.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 27, 2010 (75 FR 59268), we announced the
availability of a draft guidance entitled ``Draft Guidance for
Industry: Acidified Foods'' and gave interested parties an opportunity
to submit comments by December 27, 2010, for us to consider before
beginning work on the final version of the guidance. The draft guidance
was intended to complement our regulations regarding acidified foods
(including regulations for specific current good manufacturing practice
(21 CFR part 114), establishment registration (21 CFR 108.25(c)(1)),
and process filing (21 CFR 108.25(c)(2)) by helping commercial food
processors in determining whether their food products are subject to
these regulations and by providing for voluntary submission of process
filings by processors who conclude that their products are non-
acidified foods (e.g., acid foods or fermented foods). The draft
guidance also was intended to help processors of acidified foods in
ensuring safe manufacturing, processing, and packing processes and in
employing appropriate quality control procedures.
We are withdrawing the draft guidance, in part, because the
procedures for voluntary submission of process filings by processors of
non-acidified foods are addressed by our recently issued guidance
entitled ``Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g
(Food Process Filing Forms) to FDA in Electronic or Paper Format'' (80
FR 60909, October 8, 2015). We also are withdrawing the draft guidance,
in part, because we recently issued a final rule entitled ``Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food'' (80 FR 55908, September 17, 2015), and that
rule, along with guidance documents we are developing as a companion to
that rule, should help processors in ensuring safe manufacturing,
processing, and packing processes and in employing appropriate quality
control procedures.
Dated: December 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32781 Filed 12-29-15; 8:45 am]
BILLING CODE 4164-01-P
