Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability, 78670-78671 [2011-32368]

Download as PDF 78670 Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Notices Tosylate injection, 50 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list Bretylium Tosylate injection, 50 mg/mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to Bretylium Tosylate injection, 50 mg/ mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: December 12, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–32367 Filed 12–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 19, 2012. Submit written requests for single copies of the draft guidance document entitled ‘‘Evaluation of Sex Differences in Medical Device Clinical Studies’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. 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 Submit electronic comments on the draft guidance to https:// www.regulations.gov.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: FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2011–D–0817] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability Kathryn O’Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1546, Silver Spring, MD 20993–0002, (301) 796–6349. SUPPLEMENTARY INFORMATION: Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Evaluation of Sex Differences in Medical Device Clinical Studies.’’ This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific focus on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed in clinical trials. 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 emcdonald on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:31 Dec 16, 2011 Jkt 226001 I. Background The purpose of this guidance is to outline the Center for Devices and Radiological Health’s (CDRH’s) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and consistency of available data regarding the performance of medical devices in women. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others. The specific objectives of this guidance are to: (1) Better communicate the balance of risks and benefits of FDA-approved or cleared medical devices; (2) identify sexspecific questions for further study; and (3) encourage the consideration of sex and associated covariates (e.g., body size, plaque morphology, etc.) during the trial design stage. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on ‘‘Evaluation of Sex Differences in Medical Device Clinical Studies.’’ 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 https://www.regulations.gov. To receive ‘‘Evaluation of Sex Differences in Medical Device Clinical Studies,’’ 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 1727 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 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 812.25(c) have been approved under OMB control number 0910–0078; 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 814 Subparts B and E have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 814 Subpart H have been approved under OMB control number 0910–0332; the collections of information in 21 CFR part 822 have been approved under OMB control number 0910–0449. 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. E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Notices 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: December 13, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting 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 meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. emcdonald on DSK5VPTVN1PROD with NOTICES [FR Doc. 2011–32459 Filed 12–16–11; 8:45 am] National Institute on Drug Abuse; Notice of Closed Meetings BILLING CODE 4140–01–P National Institute of Mental Health; Notice of Closed Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute of Child Health and Human Development; Special Emphasis Panel. Folic Acid Supplementation and Semen Quality Trial. Date: January 10, 2012. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 435–6680, skandasa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) 19:31 Dec 16, 2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4160–01–P VerDate Mar<15>2010 Dated: December 13, 2011. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2011–32368 Filed 12–16–11; 8:45 am] Jkt 226001 78671 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 meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel, NIMH K22 Review. Date: January 5, 2012. Time: 12 p.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard Rockville, MD 20852 (Telephone Conference Call). Contact Person: David M. Armstrong, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center/ Room 6138/MSC 9608, 6001 Executive Boulevard Bethesda, MD 20892–9608, (301) 443–3534, armstrda@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: December 12, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–32425 Filed 12–16–11; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 National Institutes of Health 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. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Drugged Driving: Future Research Directions (5569). Date: January 11, 2012. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard Rockville, MD 20852 (Telephone Conference Call). Contact Person: Gerald L. McLaughlin, Ph.D. Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd. Room 4238, MSC 9550, Bethesda, MD 20892–9550, (301) 402–6626, gm145a@nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Feasibility of Development of RNAi-based Therapeutics for Treatment of HIV and HVC Infections in Drug Abusing Populations (8907). Date: January 13, 2012. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard Rockville, MD 20852 (Telephone Conference Call). Contact Person: Minna Liang, Ph.D., Scientific Review Officer, Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd. Room 4226, MSC 9550, Bethesda, MD 20892–9550, (301) 435–1432, liangm@nida.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Development of a Solid Dosage Form for Fenobam (8906). Date: January 18, 2012. Time: 11 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78670-78671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32368]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0817]

Draft Guidance for Industry and Food and Drug Administration
Staff; Evaluation of Sex Differences in Medical Device Clinical
Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Evaluation of Sex
Differences in Medical Device Clinical Studies.'' This document
provides guidance on the study and evaluation of sex differences in
medical device clinical trials, with a specific focus on addressing
potential differences in study design, conduct, outcomes, and
interpretation that should be considered to ensure sex-specific issues
are adequately addressed in clinical trials. 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 of 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 March 19, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Evaluation of Sex Differences in Medical
Device Clinical Studies'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. 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: Kathryn O'Callaghan, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1546, Silver Spring, MD 20993-0002,
(301) 796-6349.

SUPPLEMENTARY INFORMATION:

I. Background

The purpose of this guidance is to outline the Center for Devices
and Radiological Health's (CDRH's) expectations regarding sex-specific
patient enrollment, data analysis, and reporting of study information.
The intent is to improve the quality and consistency of available data
regarding the performance of medical devices in women. This information
can be of benefit to patients and their medical providers, as well as
clinical researchers and others. The specific objectives of this
guidance are to: (1) Better communicate the balance of risks and
benefits of FDA-approved or cleared medical devices; (2) identify sex-
specific questions for further study; and (3) encourage the
consideration of sex and associated covariates (e.g., body size, plaque
morphology, etc.) during the trial design stage.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ``Evaluation
of Sex Differences in Medical Device Clinical Studies.'' 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 https://www.regulations.gov. To receive
``Evaluation of Sex Differences in Medical Device Clinical Studies,''
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 1727 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

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 812.25(c) have been approved under
OMB control number 0910-0078; 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 814 Subparts B and
E have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814 Subpart H have been
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 822 have been approved under OMB control
number 0910-0449.

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.

[[Page 78671]]

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: December 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32368 Filed 12-16-11; 8:45 am]
BILLING CODE 4160-01-P

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