Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability, 50483-50484 [2011-20652]

Download as PDF Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–20646 Filed 8–12–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Application Requirements for the Low Income Home Energy Assistance Program (LIHEAP) Residential Energy Assistance Challenge Program (REACH) Model Plan. OMB No.: 0970–0348. Description: States, including the District of Columbia, Tribes, Tribal organizations and Territories applying for LIHEAP REACH funds must Submit an annual application prior to receiving Federal funds. The Human Services Amendments of 1994 (Pub. L. 103–252) amended the LIHEAP statute to add Section 2607B, which established the REACH program. REACH was funded for the first time in FY 1996 and is intended to: (1) Minimize health and safety risks that result from high energy burdens on low-income Americans; (2) reduce home energy vulnerability and prevent homelessness as a result of the inability to pay energy bills; (3) increase 50483 the efficiency of energy usage by lowincome families, helping them achieve energy self-sufficiency; and (4) target energy assistance to individuals who are most in need. The REACH Model Plan clarifies the information being requested and ensures the submission of all the information required by statute. The form facilitates our response to numerous queries each year concerning the information that should be included in the REACH application. Submission of a REACH application and use of the REACH Model Plan is voluntary. Grantees have the option to use another format. Respondents: State Governments, Tribal governments, Insular Areas, the District of Columbia, and the Commonwealth of Puerto Rico. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Reach model plan ............................................................................ srobinson on DSK4SPTVN1PROD with NOTICES Instrument 51 1 72 3,672 Estimated Total Annual Burden Hours: 3,672. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–20613 Filed 8–12–11; 8:45 am] BILLING CODE 4184–01–P VerDate Mar<15>2010 16:05 Aug 12, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0577] Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.’’ The recommendations in this guidance are intended to provide greater clarity on FDA’s decisionmaking process with regard to benefit-risk determinations in the premarket review of medical devices. This draft guidance is not final nor is it in effect at this time. 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 electronic or written comments on the draft guidance by November 14, 2011. SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Submit written requests for single copies of the draft guidance document entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. 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 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: For Devices Regulated by CDRH: Rachel Turow, Center for Devices and ADDRESSES: E:\FR\FM\15AUN1.SGM 15AUN1 50484 Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993–0002, 301–796–5094. For Devices Regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: Making Benefit-Risk Determinations in Medical Device Premarket Review’’ from CDRH, you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1772 to identify the guidance you are requesting. I. Background There are many factors that go into weighing the probable benefit of a device versus its probable risk. This draft guidance sets out the factors FDA considers when making this determination and explains them in detail. This draft guidance also gives examples of how the factors interrelate and how they may affect FDA’s decisions. By clarifying FDA’s decisionmaking process in this way, we hope to improve the predictability, consistency, and transparency of the review process for applicable devices. This draft guidance also includes for public comment a draft worksheet that reviewers may use in making benefitrisk determinations. The worksheet is attached as appendix A to the guidance. This level of documentation is very helpful to maintaining the consistency of review across the different review divisions and better assuring that an appropriate decision is reached. FDA tentatively concludes that this draft guidance contains no new collections of information. This draft guidance refers to currently 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 807, subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231. srobinson on DSK4SPTVN1PROD with NOTICES II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the Agency’s current thinking on factors to consider when making benefit-risk determinations in medical device premarket review. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at either https://www.regulations.gov or https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Factors to Consider When VerDate Mar<15>2010 16:05 Aug 12, 2011 Jkt 223001 IV. Paperwork Reduction Act of 1995 V. 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. Dated: August 10, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–20652 Filed 8–12–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0567] Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00034 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Design Considerations for Pivotal Clinical Investigations for Medical Devices.’’ This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time. SUMMARY: 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 November 14, 2011. DATES: Submit written requests for single copies of the draft guidance document entitled ‘‘Design Considerations for Pivotal Clinical Investigations for Medical Devices’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002, or to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. 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 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. ADDRESSES: Greg Campbell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2110, Silver Spring, MD 20993–0002, 301–796–5750. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50483-50484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20652]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0577]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Review; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance document entitled ``Factors to 
Consider When Making Benefit-Risk Determinations in Medical Device 
Premarket Review.'' The recommendations in this guidance are intended 
to provide greater clarity on FDA's decisionmaking process with regard 
to benefit-risk determinations in the premarket review of medical 
devices. This draft guidance is not final nor is it in effect at this 
time.

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 electronic or written comments on the draft guidance 
by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Factors to Consider When Making Benefit-
Risk Determinations in Medical Device Premarket Review'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health (CDRH), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002; or to the Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    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 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: For Devices Regulated by CDRH: Rachel 
Turow, Center for Devices and

[[Page 50484]]

Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002, 301-796-5094.
    For Devices Regulated by CBER: Stephen Ripley, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    There are many factors that go into weighing the probable benefit 
of a device versus its probable risk. This draft guidance sets out the 
factors FDA considers when making this determination and explains them 
in detail. This draft guidance also gives examples of how the factors 
interrelate and how they may affect FDA's decisions. By clarifying 
FDA's decisionmaking process in this way, we hope to improve the 
predictability, consistency, and transparency of the review process for 
applicable devices.
    This draft guidance also includes for public comment a draft 
worksheet that reviewers may use in making benefit-risk determinations. 
The worksheet is attached as appendix A to the guidance. This level of 
documentation is very helpful to maintaining the consistency of review 
across the different review divisions and better assuring that an 
appropriate decision is reached.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the Agency's current thinking on factors 
to consider when making benefit-risk determinations in medical device 
premarket review. 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 statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at either https://www.regulations.gov or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Review'' from CDRH, you may either send an e-
mail request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1772 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no new 
collections of information. This draft guidance refers to currently 
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 
807, subpart E have been approved under OMB control number 0910-0120; 
and the collections of information in 21 CFR part 814 have been 
approved under OMB control number 0910-0231.

V. 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.

    Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20652 Filed 8-12-11; 8:45 am]
BILLING CODE 4160-01-P
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