Draft Guidance for Industry on Acrylamide in Foods; Availability, 68852-68853 [2013-27362]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES 68852 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices achieve community benefits such as improved services for their communities (especially Medicare beneficiaries), meet their individual strategic goals, and improve the financial solvency and viability of the participating hospitals. In addition, the evaluation will determine if it is feasible and advisable to create a new payment category of rural hospitals. To achieve this objective, the evaluation will examine how RCHD hospitals responded to payment options and assess how the costs to Medicare under RCHD compare to existing alternative payment options. The evaluation will also summarize the characteristics of the markets served by RCHD hospitals, including beneficiaries’ proximity to inpatient providers and competition among providers in the area. The information will be used to assess the implications of expanding the RCHD payment system to hospitals in various market environments. In addition, the evaluation will examine the potential costs of expanding the RCHD payment methodology, accounting for alternative approaches to targeting rural hospitals. Form Number: CMS–10508 (OCN: 0938–NEW); Frequency: Annually; Affected Public: State, Local or Tribal Governments, Private sector—Business or other for-profit and Not-for-profit organizations; Number of Respondents: 57; Total Annual Responses: 101; Total Annual Hours: 245. (For policy questions regarding this collection contact Woolton Lee at 410–786–4942.) 2. Title of Information Collection: State-based Marketplace Annual Report (SMAR); Type of Information Collection Request: New collection (Request for a new OMB control number); Use: The annual report is the primary vehicle to insure comprehensive compliance with all reporting requirements contained in the Affordable Care Act. It is specifically called for in section 1313(a)(1) of the Act which requires an State-based Marketplace (SBM) to keep an accurate accounting of all activities, receipts, and expenditures, and to submit a report annually to the Secretary concerning such accounting. We will use the information collected from states to assist in determining if a state is maintaining a compliant operational Exchange. It will also provide a mechanism to collect innovative approaches to meeting challenges encountered by the SBMs during the preceding year. Additionally, it will provide information to us regarding potential changes in priorities and approaches for the upcoming year. Form Number: CMS–10507 (OCN: 0938– NEW); Frequency: Annually; Affected Public: State, Local, or Tribal VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 governments; Number of Respondents: 19; Number of Responses: 19; Total Annual Hours: 1,482. (For policy questions regarding this collection, contact Shelley Bain at 301–492–4453.) 3. Title of Information Collection: Medicare Enrollment Application: Medicare Part A Institutional Providers; Type of Information Collection Request: Revision of a currently approved collection ; Use: We are revising the CMS–855 Medicare Enrollment Applications information collection request to remove the CMS–855I, CMS– 855B and CMS–855R applications from its collection. We have found that the regulations governing the enrollment requirements for health care facilities occur at intervals separate from the other provider and supplier types reimbursed by Medicare. Consequently, we may need to revise and submit the CMS–855A enrollment application for OMB approval at intervals separate from the other enrollment applications which include the CMS–855B, CMS–855I and CMS–855R enrollment applications. The ability to revise the CMS–855A separately from the other CMS–855 enrollment applications will lessen the burden on us and OMB as well as the public during the Federal Register notice period, as only one subset of provider or suppliers will be effected by CMS–855A revisions. We intend to maintain the continuity of the CMS–855 enrollment applications by using the same formats and lay-out of the current CMS–855 enrollment applications, regardless of the separation of the CMS 855A from the collective enrollment application package. At this time we are also using this opportunity to make editorial and clerical corrections to the CMS–855A to simplify and clarify the current data collection and to remove obsolete requirements and data collection. The sections and sub-sections within the form are also being re-numbered and resequenced to create a more logical flow of the data collection. In addition, we are adding a data collection for an address to mail the periodic request for the revalidation of enrollment information (only if it differs from other addresses currently collected). More specific information regarding types of Home Health Agency sub-units will also be collected. Other than the information above, new data being collected in this revision package is information on, if applicable, where the supplier stores its patient records electronically. Form Number: CMS–855A (OCN: 0938–0685); Frequency: Annually; Affected Public: State, Local, or Tribal governments; Number of Respondents: 18,000; Number of Responses: 18,000; PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Total Annual Hours: 78,000. (For policy questions regarding this collection, contact Kim McPhillips at 410–786– 5374.) Dated: November 8, 2013. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2013–27305 Filed 11–14–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0715] Draft Guidance for Industry on Acrylamide in Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Acrylamide in Foods.’’ The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 14, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS– 300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. SUMMARY: E:\FR\FM\15NON1.SGM 15NON1 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices FOR FURTHER INFORMATION CONTACT: emcdonald on DSK67QTVN1PROD with NOTICES Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1639. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Acrylamide in Foods.’’ We are issuing this draft guidance as a Level 1 draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on acrylamide in foods. 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. The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking, and is a concern because it can cause cancer in laboratory animals at high doses, and is reasonably anticipated to be a human carcinogen. Reducing acrylamide in foods may mitigate potential human health risks from exposure to acrylamide. The draft guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches. In particular, the draft guidance is intended to give information to manufacturers on selecting and handling raw materials, modifying processing practices, and choosing ingredients, so as to reduce acrylamide in potato-based foods (such as fries, sliced potato chips, and fabricated potato chips) and cereal-based foods (such as cookies, crackers, and breads). The draft guidance also discusses acrylamide reduction in coffee. The draft guidance also is intended to give information to manufacturers for placing preparation and cooking instructions on frozen French fry packages. Lastly, the draft guidance is intended to give information for food service operations on preparation of potato-based and cereal-based foods. II. Paperwork Reduction Act of 1995 This draft guidance contains proposed information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 (the PRA) (44 U.S.C. 3501–3520). ‘‘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. Federal law at 44 U.S.C. 3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice of the proposed collection of information in a future issue of the Federal Register. III. Comments Interested persons may submit either electronic comments regarding the draft guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the draft guidance. Dated: November 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27362 Filed 11–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1306] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 68853 Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the diverse international regulatory requirements of medical devices quality management systems and other specific regulatory requirements of the regulatory authorities participating in the pilot program. FDA will be participating in the MDSAP and will accept the resulting audit reports as a substitute for routine Agency inspections. ADDRESSES: Submit electronic comments on the MDSAP International Coalition Pilot Program to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Kimberly A. Trautman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5400, Silver Spring, MD 20993–0002, 301– 796–5515, Kimberly.Trautman@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The International Medical Device Regulators Forum (IMDRF) was conceived in 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world, which includes FDA, who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices. The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence. See http://www.imdrf .org/. The IMDRF recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group (WG) to develop specific documents for advancing the concept of the MDSAP. See http://www.imdrf.org/. This global approach opens possibilities and pathways to support the development of an international initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68852-68853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0715]


Draft Guidance for Industry on Acrylamide in Foods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Acrylamide in Foods.'' The draft guidance is intended to provide 
information that may help growers, manufacturers, and food service 
operators reduce acrylamide in certain foods. Acrylamide is a chemical 
that can form in some foods during certain types of high-temperature 
cooking. The draft guidance is intended to suggest a range of possible 
approaches to acrylamide reduction and not to identify specific 
recommended approaches.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
January 14, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Food Safety, Center for Food Safety and 
Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive 
labels to assist that office in processing your request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 68853]]


FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1639.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance entitled 
``Guidance for Industry: Acrylamide in Foods.'' We are issuing this 
draft guidance as a Level 1 draft guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on acrylamide in foods. 
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.
    The draft guidance is intended to provide information that may help 
growers, manufacturers, and food service operators reduce acrylamide in 
certain foods. Acrylamide is a chemical that can form in some foods 
during certain types of high-temperature cooking, and is a concern 
because it can cause cancer in laboratory animals at high doses, and is 
reasonably anticipated to be a human carcinogen. Reducing acrylamide in 
foods may mitigate potential human health risks from exposure to 
acrylamide. The draft guidance is intended to suggest a range of 
possible approaches to acrylamide reduction and not to identify 
specific recommended approaches.
    In particular, the draft guidance is intended to give information 
to manufacturers on selecting and handling raw materials, modifying 
processing practices, and choosing ingredients, so as to reduce 
acrylamide in potato-based foods (such as fries, sliced potato chips, 
and fabricated potato chips) and cereal-based foods (such as cookies, 
crackers, and breads). The draft guidance also discusses acrylamide 
reduction in coffee. The draft guidance also is intended to give 
information to manufacturers for placing preparation and cooking 
instructions on frozen French fry packages. Lastly, the draft guidance 
is intended to give information for food service operations on 
preparation of potato-based and cereal-based foods.

II. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). ``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. Federal law at 44 U.S.C. 
3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in 
the Federal Register for each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, we will publish a 60-day notice of the proposed collection 
of information in a future issue of the Federal Register.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of 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, and will be posted to 
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the draft guidance.

    Dated: November 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27362 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P