Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption Regulation; Questions and Answers; Availability, 39263-39264 [2010-16548]

Download as PDF 39263 Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Respondents Baseline Questionnaire (for Children with asthma 7–12 years). Baseline Questionnaire (for Children 0–6 years) ............ Mothers of enrolled children. Mothers of enrolled children. Mothers of enrolled children/Pregnant Women. Mothers of enrolled children/Pregnant Women. Mothers of enrolled children/Pregnant Women. Mothers of enrolled children. Mothers of enrolled children. Mothers of enrolled children. Mothers of enrolled children. Mothers of enrolled children/Pregnant Women. Pregnant Women ............... 3- and 9-month Phone contact ....................................... 6- and 12-month Follow-up Questionnaire (for environment). 6- and 12-month Follow-up Questionnaire (for women) 6- and 12-month Follow-up Questionnaire (for Children with asthma 7–12 years). 6- and 12-month Follow-up Questionnaire (for children 0–6). Time/Activity form (for Children with asthma 7–12 years). Time/Activity form (for Children 0–6 years) .................... Time/Activity form (for Pregnant women or mothers) ..... Post-delivery questionnaire ............................................. Dated: June 30, 2010. Maryam I. Daneshvar, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–16601 Filed 7–7–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0434] Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption Regulation; Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Humanitarian Device Exemption (HDE) Regulation: Questions and Answers.’’ This guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs. DATES: Submit either electronic or written comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document VerDate Mar<15>2010 18:10 Jul 07, 2010 Jkt 220001 entitled ‘‘Humanitarian Device Exemption (HDE) Regulation: Questions and Answers’’ to the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA), 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 CDRH at 301–847– 8149. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the 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: Sheila Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1651, Silver Spring, MD 20993–0002, 301–796–6563, or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Number of responses per respondent Number of respondents Forms Average burden per response (in hours) 688 1 15/60 688 1 15/60 1,376 2 5/60 1,376 2 10/60 1,376 2 10/60 688 2 10/60 688 2 10/60 688 4 5/60 688 4 5/60 1,376 4 5/60 688 1 5/60 Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background This guidance answers commonly asked questions about HUDs and applications for HDE authorized by section 510(m)(2) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360(m)(2)). This update of the version issued in 2006 reflects additional requirements set forth in the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85). The Pediatric Medical Device Safety and Improvement Act of 2007 includes a provision requiring that all original HDE applications include both a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients (new section 515A(a)(2) of the act). It also amends section 520(m) of the act to exempt some HUDs from the prohibition on profit (new section 520(m)(6) of the act). Specifically, HDE applications indicated for use in pediatric patients that are approved on or after September 27, 2007, may be assigned an annual distribution number (ADN) and be sold for profit, subject to certain restrictions. Finally, the Pediatric Medical Device Safety and Improvement Act of 2007 includes a provision requiring that the agency provide guidance to Institutional Review Boards (IRBs) on the review of HUDs. This update of the HDE guidance E:\FR\FM\08JYN1.SGM 08JYN1 39264 Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / Notices includes 29 specific questions and answers for IRBs as well as guidance to HDE holders on whether and how they may become eligible to receive profit from the sale of their device. In the Federal Register of August 5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public comment. The comment period closed on November 3, 2008. FDA published a 30-day notice on September 30, 2009 (74 FR 50214), but republished a 30-day notice on February 18, 2010 (75 FR 7270), to provide a more descriptive response to the comments received in response to the August 5, 2008, notice. This document supersedes: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers, issued July 18, 2006. 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. (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) Dated: July 1, 2010. Nancy Stade, Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Significance of Guidance [FR Doc. 2010–16548 Filed 7–7–10; 8:45 am] This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on the ‘‘HDE Regulation: Questions and Answers.’’ 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. BILLING CODE 4160–01–S Health Resources and Services Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘HDE Regulation: Questions and Answers,’’ 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 1668 to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. srobinson on DSKHWCL6B1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 this guidance were approved under OMB control number 0910–0661, May 31, 2013, expiration date. VerDate Mar<15>2010 17:09 Jul 07, 2010 Jkt 220001 National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and 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 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 Child Health and Human Development Special Emphasis Panel: Therapeutic Application of Dyrk1A Inhibitors for Down Syndrome. Date: July 26, 2010. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Neelakanta Ravindranath, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5B01G, Bethesda, MD 20892–7510, (301) 435–6889, ravindrn@mail.nih.gov. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Dated: June 30, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–16472 Filed 7–7–10; 8:45 am] BILLING CODE 4140–01–P Centers for Disease Control and Prevention In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the CDC and HRSA announce the following committee meeting. Time and Date: 2 p.m.–3:30 p.m., July 29, 2010. Place: Teleconference. To participate, please dial (877) 952–1988 and enter passcode 2162797 for access. Status: Open to the public, limited only by availability of telephone ports. Purpose: This Committee is charged with advising the Director, CDC and the Administrator, HRSA, regarding activities related to prevention and control of HIV/ AIDS and other STDs, the support of health care services to persons living with HIV/ AIDS, and education of health professionals and the public about HIV/AIDS and other STDs. Matters To Be Discussed: The purpose of the teleconference is for CHACHSPT to deliberate and discuss the outcomes of a CDC/HRSA Advisory Committee workgroup that will convene on July 8, 2010. The workgroup will conduct a program review to provide information to CHACHSPT on the strategic realignment of funding to support priorities in sexual health and STD disparities among racial and ethnic minorities. The objectives of the workgroup are: (1) To identify to CHACHSPT future opportunities to accelerate the impact in health disparities through programs, policy, and research and public health ethics; (2) To provide information to CHACHSPT regarding potential use of realigned funding; and, (3) To provide key principles (e.g., program, policy, research) to be considered by CHACHSPT in the development of a new funding opportunity announcement for the use of realigned resources. For More Information Contact: Margie Scott-Cseh, CDC, National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 75, Number 130 (Thursday, July 8, 2010)]
[Notices]
[Pages 39263-39264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16548]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0434]


Guidance for Humanitarian Device Exemption Holders, Institutional 
Review Boards, Clinical Investigators, and Food and Drug Administration 
Staff; Humanitarian Device Exemption Regulation; Questions and Answers; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Humanitarian Device Exemption 
(HDE) Regulation: Questions and Answers.'' This guidance answers 
commonly asked questions about Humanitarian Use Devices (HUDs) and 
applications for HDEs.

DATES:  Submit either electronic or written comments on this guidance 
at any time. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Humanitarian Device Exemption (HDE) Regulation: 
Questions and Answers'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (DSMICA), 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 CDRH at 301-847-8149. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the 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:  Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1651, Silver Spring, MD 20993-0002, 301-796-6563, 
or 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

    This guidance answers commonly asked questions about HUDs and 
applications for HDE authorized by section 510(m)(2) of the Federal 
Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360(m)(2)). This 
update of the version issued in 2006 reflects additional requirements 
set forth in the Pediatric Medical Device Safety and Improvement Act of 
2007 (Public Law 110-85). The Pediatric Medical Device Safety and 
Improvement Act of 2007 includes a provision requiring that all 
original HDE applications include both a description of any pediatric 
subpopulations that suffer from the disease or condition that the 
device is intended to treat, diagnose, or cure, and the number of 
affected pediatric patients (new section 515A(a)(2) of the act). It 
also amends section 520(m) of the act to exempt some HUDs from the 
prohibition on profit (new section 520(m)(6) of the act). Specifically, 
HDE applications indicated for use in pediatric patients that are 
approved on or after September 27, 2007, may be assigned an annual 
distribution number (ADN) and be sold for profit, subject to certain 
restrictions. Finally, the Pediatric Medical Device Safety and 
Improvement Act of 2007 includes a provision requiring that the agency 
provide guidance to Institutional Review Boards (IRBs) on the review of 
HUDs. This update of the HDE guidance

[[Page 39264]]

includes 29 specific questions and answers for IRBs as well as guidance 
to HDE holders on whether and how they may become eligible to receive 
profit from the sale of their device. In the Federal Register of August 
5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public 
comment. The comment period closed on November 3, 2008. FDA published a 
30-day notice on September 30, 2009 (74 FR 50214), but republished a 
30-day notice on February 18, 2010 (75 FR 7270), to provide a more 
descriptive response to the comments received in response to the August 
5, 2008, notice. This document supersedes: Humanitarian Device 
Exemption (HDE) Regulation: Questions and Answers, issued July 18, 
2006.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the ``HDE Regulation: Questions and 
Answers.'' 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 guidance may do so by 
using the Internet. To receive ``HDE Regulation: Questions and 
Answers,'' 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 
1668 to identify the guidance you are requesting. 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 or the CBER Internet site at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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 this guidance were approved under OMB 
control number 0910-0661, May 31, 2013, expiration date.

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: July 1, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for 
Devices and Radiological Health.
[FR Doc. 2010-16548 Filed 7-7-10; 8:45 am]
BILLING CODE 4160-01-S
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