80 FR 81550 - Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 250 (December 30, 2015)

Page Range		81550-81551
FR Document		2015-32781

The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry, entitled ``Draft Guidance for Industry: Acidified Foods.'' The draft guidance was intended to complement our regulations regarding acidified foods (including regulations for specific current good manufacturing practice, establishment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 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 We are withdrawing the draft guidance, in part, because many of the topics addressed in the draft guidance are now being addressed in other documents.

Federal Register, Volume 80 Issue 250 (Wednesday, December 30, 2015)

[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81550-81551]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32781]


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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Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft 
Guidance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.

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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withdrawal of a draft guidance for industry, entitled ``Draft Guidance 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 The draft guidance was intended to 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

81550 Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices

DEPARTMENT OF HEALTH AND 3. Call the Reports Clearance Office at continuously improve its Web sites
HUMAN SERVICES (410) 786–1326. though regular surveys developed from
FOR FURTHER INFORMATION CONTACT: these pre-defined questions. Surveying
Centers for Medicare & Medicaid Reports Clearance Office at (410) 786– the Agency Web sites on a regular,
Services 1326. ongoing basis will help ensure that
[Document Identifiers: CMS–10415] users have an effective, efficient, and
SUPPLEMENTARY INFORMATION: Under the
satisfying experience on any of the Web
Paperwork Reduction Act of 1995 (PRA)
Agency Information Collection sites, maximizing the impact of the
(44 U.S.C. 3501–3520), federal agencies
Activities: Submission for OMB information and resulting in optimum
must obtain approval from the Office of
Review; Comment Request benefit for the public. The surveys will
Management and Budget (OMB) for each
ensure that this communication channel
ACTION: Notice. collection of information they conduct
meets customer and partner priorities,
or sponsor. The term ‘‘collection of
builds the Agency’s brands, and
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
contributes to the Agency’s health and
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
human services impact goals. Note that
an opportunity for the public to includes agency requests or
the burden estimate for the collection
comment on CMS’ intention to collect requirements that members of the public
has increased from the figure published
information from the public. Under the submit reports, keep records, or provide
in the 60-day notice (80 FR 66904). In
Paperwork Reduction Act of 1995 information to a third party. Section
the 60-day notice, we did not account
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. for the currently approved burden that
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies will be retained and then add it to the
concerning each proposed collection of to publish a 30-day notice in the new burden for which we are seeking
information, including each proposed Federal Register concerning each approval. The total is now 50,000 hours.
extension or reinstatement of an existing proposed collection of information, Form Number: CMS–10415 (OMB
collection of information, and to allow including each proposed extension or control number: 0938–1185); Frequency:
a second opportunity for public reinstatement of an existing collection Occasionally; Affected Public:
comment on the notice. Interested of information, before submitting the Individuals and Households, Business
persons are invited to send comments collection to OMB for approval. To or other for-profits and Not-for-profit
regarding the burden estimate or any comply with this requirement, CMS is institutions, State, Local or Tribal
other aspect of this collection of publishing this notice that summarizes Governments; Number of Respondents:
information, including any of the the following proposed collection(s) of 1,000,000; Total Annual Responses:
following subjects: (1) The necessity and information for public comment: 1,000,000; Total Annual Hours: 50,000.
utility of the proposed information 1. Type of Information Collection (For policy questions regarding this
collection for the proper performance of Request: Extension of a currently collection contact John Booth at 410–
the agency’s functions; (2) the accuracy approved collection; Title of 786–6577.)
of the estimated burden; (3) ways to Information Collection: Generic
enhance the quality, utility, and clarity Clearance for the Collection Customer Dated: December 22, 2015.
of the information to be collected; and Satisfaction Surveys; Use: This William N. Parham, III,
(4) the use of automated collection collection of information is necessary to Director, Paperwork Reduction Staff, Office
techniques or other forms of information enable the Agency to garner customer of Strategic Operations and Regulatory
technology to minimize the information and stakeholder feedback in an efficient, Affairs.
collection burden. timely manner, in accordance with our [FR Doc. 2015–32633 Filed 12–29–15; 8:45 am]
DATES: Comments on the collection(s) of commitment to improving service BILLING CODE 4120–01–P
information must be received by the delivery. The information collected
OMB desk officer by January 29, 2016. from our customers and stakeholders
will help ensure that users have an DEPARTMENT OF HEALTH AND
ADDRESSES: When commenting on the
effective, efficient, and satisfying HUMAN SERVICES
proposed information collections,
please reference the document identifier experience with the Agency’s programs. Food and Drug Administration
or OMB control number. To be assured This feedback will provide insights into
consideration, comments and customer or stakeholder perceptions, [Docket No. FDA–2010–D–0434]
recommendations must be received by experiences and expectations, provide
an early warning of issues with service, Acidified Foods; Draft Guidance for
the OMB desk officer via one of the
or focus attention on areas where Industry; Withdrawal of Draft Guidance
following transmissions: OMB, Office of
Information and Regulatory Affairs, communication, training or changes in AGENCY: Food and Drug Administration,
Attention: CMS Desk Officer, Fax operations might improve delivery of HHS.
Number: (202) 395–5806 or Email: products or services. These collections ACTION: Notice; withdrawal.
OIRA_submission@omb.eop.gov. will allow for ongoing, collaborative and
To obtain copies of a supporting actionable communications between the SUMMARY: The Food and Drug
statement and any related forms for the Agency and its customers and Administration (FDA or we) is
proposed collection(s) summarized in stakeholders. It will also allow feedback announcing the withdrawal of a draft
this notice, you may make your request to contribute directly to the guidance for industry, entitled ‘‘Draft
mstockstill on DSK4VPTVN1PROD with NOTICES

using one of following: improvement of program management. Guidance for Industry: Acidified
1. Access CMS’ Web site address at Collecting voluntary customer Foods.’’ The draft guidance was
http://www.cms.hhs.gov/Paperwork feedback is the least burdensome, most intended to complement our regulations
ReductionActof1995. effective way for the Agency to regarding acidified foods (including
2. Email your request, including your determine whether or not its public Web regulations for specific current good
address, phone number, OMB number, sites are useful to and used by its manufacturing practice, establishment
and CMS document identifier, to customers. Generic clearance is needed registration, and process filing) by
Paperwork@cms.hhs.gov. to ensure that the Agency can helping commercial food processors

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Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices 81551

determine whether their food products Practice, Hazard Analysis, and Risk- rohini.khillan@hhs.gov. Note: Seating
are subject to these regulations by Based Preventive Controls for Human may be limited. Those wishing to attend
providing for voluntary submission of Food’’ (80 FR 55908, September 17, the meeting must send an email to
process filings by processors of non- 2015), and that rule, along with napa@hhs.gov and put ‘‘January 25
acidified foods (e.g., some acid foods or guidance documents we are developing Meeting Attendance’’ in the Subject line
fermented foods), and by helping as a companion to that rule, should help by Friday, January 15, so that their
processors of acidified foods in ensuring processors in ensuring safe names may be put on a list of expected
safe manufacturing, processing, and manufacturing, processing, and packing attendees and forwarded to the security
packing processes and in employing processes and in employing appropriate officers at the National Institutes of
appropriate quality control procedures. quality control procedures. Health. Any interested member of the
We are withdrawing the draft guidance, Dated: December 23, 2015. public who is a non-U.S. citizen should
in part, because many of the topics include this information at the time of
Leslie Kux,
addressed in the draft guidance are now registration to ensure that the
Associate Commissioner for Policy.
being addressed in other documents. appropriate security procedure to gain
[FR Doc. 2015–32781 Filed 12–29–15; 8:45 am]
DATES: The withdrawal is effective entry to the building is carried out.
BILLING CODE 4164–01–P Although the meeting is open to the
December 30, 2015.
FOR FURTHER INFORMATION CONTACT: public, procedures governing security
Michael Mignogna, Center for Food and the entrance to Federal buildings
DEPARTMENT OF HEALTH AND
Safety and Applied Nutrition (HFS– may change without notice. If you wish
HUMAN SERVICES
302), Food and Drug Administration, to make a public comment, you must
5100 Paint Branch Pkwy., College Park, Advisory Council on Alzheimer’s note that within your email.
MD 20740, 240–402–1565. Research, Care, and Services; Meeting SUPPLEMENTARY INFORMATION: Notice of
SUPPLEMENTARY INFORMATION: In a notice these meetings is given under the
published in the Federal Register of AGENCY: Assistant Secretary for Federal Advisory Committee Act (5
September 27, 2010 (75 FR 59268), we Planning and Evaluation, HHS. U.S.C. App. 2, section 10(a)(1) and
announced the availability of a draft ACTION: Notice of meeting. (a)(2)). Topics of the Meeting:
guidance entitled ‘‘Draft Guidance for SUMMARY: This notice announces the During the January meeting, the
Industry: Acidified Foods’’ and gave public meeting of the Advisory Council Advisory Council will review the
interested parties an opportunity to on Alzheimer’s Research, Care, and process for developing
submit comments by December 27, Services (Advisory Council). The recommendations and developing the
2010, for us to consider before Advisory Council on Alzheimer’s National Plan to Address Alzheimer’s
beginning work on the final version of Research, Care, and Services provides Disease, discuss updates to work on
the guidance. The draft guidance was advice on how to prevent or reduce the Goals 2 and 3 of the National Plan, and
intended to complement our regulations burden of Alzheimer’s disease and hear updates on a future summit on
regarding acidified foods (including related dementias on people with the care.
regulations for specific current good disease and their caregivers. During the Procedure and Agenda: This meeting
manufacturing practice (21 CFR part January meeting, the Advisory Council is open to the public. Please allow 45
114), establishment registration (21 CFR will review the process for developing minutes to go through security and walk
108.25(c)(1)), and process filing (21 CFR recommendations and developing the to the meeting room. The meeting will
108.25(c)(2)) by helping commercial National Plan to Address Alzheimer’s also be webcast at www.hhs.gov/live.
food processors in determining whether Disease, discuss updates to work on Authority: 42 U.S.C. 11225; Section
their food products are subject to these Goals 2 and 3 of the National Plan, and 2(e)(3) of the National Alzheimer’s
regulations and by providing for hear updates on a future summit on Project Act. The panel is governed by
voluntary submission of process filings care. provisions of Public Law 92–463, as
by processors who conclude that their amended (5 U.S.C. Appendix 2), which
products are non-acidified foods (e.g., DATES: The meeting will be held on
sets forth standards for the formation
acid foods or fermented foods). The January 25, 2016 from 9:30 a.m. to 5:00
and use of advisory committees.
draft guidance also was intended to help p.m. EDT.
ADDRESSES: The meeting will be held in Dated: December 21, 2015.
processors of acidified foods in ensuring
safe manufacturing, processing, and Room 6, Building 31 of the National Richard G. Frank,
packing processes and in employing Institutes of Health, 9000 Rockville Assistant Secretary for Planning and
appropriate quality control procedures. Pike, Bethesda, Maryland 20892. Evaluation.
We are withdrawing the draft Comments: Time is allocated in the [FR Doc. 2015–32890 Filed 12–29–15; 8:45 am]
guidance, in part, because the afternoon on the agenda to hear public BILLING CODE 4150–05–P
procedures for voluntary submission of comments. The time for oral comments
process filings by processors of non- will be limited to two (2) minutes per
acidified foods are addressed by our individual. In lieu of oral comments, DEPARTMENT OF HEALTH AND
recently issued guidance entitled formal written comments may be HUMAN SERVICES
‘‘Submitting Form FDA 2541 (Food submitted for the record to Rohini
Khillan, ASPE, 200 Independence National Institutes of Health
Canning Establishment Registration)
Avenue SW., Room 424E, Washington,
mstockstill on DSK4VPTVN1PROD with NOTICES

and Forms FDA 2541d, FDA 2541e, National Institute of Allergy and
FDA 2541f, and FDA 2541g (Food DC 20201. Comments may also be sent
Infectious Diseases; Notice of Closed
Process Filing Forms) to FDA in to napa@hhs.gov. Those submitting
Meetings
Electronic or Paper Format’’ (80 FR written comments should identify
60909, October 8, 2015). We also are themselves and any relevant Pursuant to section 10(d) of the
withdrawing the draft guidance, in part, organizational affiliations. Federal Advisory Committee Act, as
because we recently issued a final rule FOR FURTHER INFORMATION CONTACT: amended (5 U.S.C. App.), notice is
entitled ‘‘Current Good Manufacturing Rohini Khillan (202) 690–5932, hereby given of the following meetings.

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Document Created: 2015-12-30 03:16:16
Document Modified: 2015-12-30 03:16:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; withdrawal.
Dates		The withdrawal is effective December 30, 2015.
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.
FR Citation		80 FR 81550

80 FR 81550 - Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 250 (December 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration