Draft Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval-The Premarket Approval Supplement Decision-Making Process; Availability, 14282-14283 [E7-5572]

Download as PDF 14282 Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cathy Groupe at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 20, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–5506 Filed 3–26–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0083] Draft Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval—The Premarket Approval Supplement Decision-Making Process; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. I. Background The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)— The PMA Supplement Decision-Making Process.’’ This draft guidance is intended to help the regulated industry determine whether submitting a PMA supplement or other notification to FDA is required for class III devices subject to PMA. This draft guidance is not final nor is it in effect at this time. DATES: Submit written or electronic comments on this draft guidance by June 25, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—The PMA Supplement Decision-Making Process’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., sroberts on PROD1PC70 with NOTICES SUMMARY: VerDate Aug<31>2005 16:38 Mar 26, 2007 Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 240–276–3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For general questions: Thinh Nguyen, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240– 276–4010. For questions about the 30-day notice program or regarding manufacturing site changes: Christy Foreman, Center for Devices and Radiological Health (HFZ–340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240–276–0120. For biologics issues: Leonard Wilson, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301– 827–0373. SUPPLEMENTARY INFORMATION: Jkt 211001 This draft guidance is intended to help the regulated industry determine whether submitting a PMA supplement or other notification to FDA is required for class III devices subject to PMA. FDA developed this draft guidance to address modifications to device design, device labeling, and the device manufacturing process. This guidance also can be applied when a legally marketed class III device is the subject of a recall or field corrective action and the manufacturer needs to change the device to assure its safety and effectiveness. This draft guidance is intended to apply to the device portion of combination products such as drug/ device or biologic/device combinations. 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 modifications to devices subject to PMA applications. It does not create or PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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. To receive ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—The PMA Supplement Decision-Making Process,’’ 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 240–276–3151 to receive a hard copy. Please use the document number 1584 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This draft 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 USC 3501–3520) (the PRA). The collections of information addressed in the draft guidance document have been approved by OMB in accordance with the PRA under the regulations governing PMA applications (21 CFR part 814, OMB control number 0910– 0231). V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that E:\FR\FM\27MRN1.SGM 27MRN1 Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices Agency Information Collection Activities: Proposed Collection; Comment Request Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Proposed Project: Independent Evaluation of the Substance Abuse Prevention and Treatment Block Grant Program—NEW The Substance Abuse and Mental Health Services Administration individuals may submit one paper copy. Comments are to be identified 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: March 16, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–5572 Filed 3–26–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration 14283 (SAMHSA), Center for Substance Abuse Treatment (CSAT), Division of State and Community Assistance administers the Substance Abuse Prevention and Treatment Block Grant (SAPT BG) in collaboration with the Center for Substance Abuse Prevention (CSAP), Division of State Programs. The Substance Abuse Prevention and Treatment Block Grant is funded by Congress to provide monies to States, Territories, and one Native American Tribe for the purpose of planning, carrying out, and evaluating activities to prevent and treat substance abuse and other allowable activities. The SAPT BG constitutes approximately 40 percent of all States budgets for substance abuse prevention and treatment services and activities, and is the primary Federal source of funding. States have flexibility in determining how funds should be allocated, but there are specific set-aside and maintenance of effort requirements that must be met in order to receive funding. These requirements, introduced by both the ADAMHA Reorganization Act of 1992 and the Children’s Health Act of 2000, are listed below: TABLE 1.—SAPT BG SET-ASIDE PROVISIONS a Category Set-aside provision Prevention and treatment activities regarding alcohol. Prevention and treatment activities regarding other drugs. Primary prevention programs ............................. Pregnant women and women with dependent children. Tuberculosis services ......................................... HIV services b ..................................................... Prohibition of sale of tobacco to individuals under age of 18 (Synar amendment). Maintenance of effort (MOE) for State expenditures. Administrative expenses .................................... Not less than 35 percent of SAPT BG funding.* Not less than 35 percent of SAPT BG funding.* Not less than 20 percent of SAPT BG funding. Not less than amount equal to expenditure in FY1994. No set amount but services must be provided to receive SAPT BG funds. No more than 5 percent increase over State allotment for HIV services in FY 1991. State must enforce law against sale of tobacco to underage individuals to receive SAPT BG funds—noncompliance leads to a 10 percent reduction in funds the first applicable fiscal year; 20 percent, the second year; 30 percent, the third year; and 40 percent, the fourth year. State will maintain funding at no less than the average level of expenditures for the 2 years preceding the fiscal year for which the State is applying. Limited to 5 percent of SAPT BG funding. a These set-asides shown in this table were included in the 1992 SAPT BG authorizing legislation 42 U.S.C. 300x–21 to 42 U.S.C. 300x–62). In the Children’s Health Act of 2000 (Pub. L. 106–310) Sec. 3303(a)(1)), however, the set-asides marked with asterisks were removed. b For designated States whose rate of AIDS cases is 10 or more per 100,000 individuals as confirmed by the Centers for Disease Control and Prevention. In addition to the set-asides, the SAPT BG Program has identified 17 goals which must be met by States in order to receive this Federal funding: TABLE 2.—FEDERAL GOALS FOR THE SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT sroberts on PROD1PC70 with NOTICES GOAL #1: Continuum of substance abuse treatment services. GOAL #2: Spending on primary prevention programs. VerDate Aug<31>2005 16:38 Mar 26, 2007 Jkt 211001 The State shall expend block grant funds to maintain a continuum of substance abuse treatment services that meet these needs for the services identified by the state (see 42 U.S.C. 300x–21(b) and 45 CFR 96.122(f)(g)). The State agrees to spend not less than 20 percent on primary prevention programs for individuals who do not require treatment for substance abuse, specifying the activities proposed for each of the six strategies (see 42 U.S.C. 300x–22(b)(1) and 45 CFR 96.124(b)(1)). PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1

Agencies

[Federal Register Volume 72, Number 58 (Tuesday, March 27, 2007)]
[Notices]
[Pages 14282-14283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0083]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Modifications to Devices Subject to Premarket Approval--The 
Premarket Approval Supplement Decision-Making Process; 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 ``Modifications to Devices 
Subject to Premarket Approval (PMA)--The PMA Supplement Decision-Making 
Process.'' This draft guidance is intended to help the regulated 
industry determine whether submitting a PMA supplement or other 
notification to FDA is required for class III devices subject to PMA. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
June 25, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Modifications to Devices Subject to 
Premarket Approval (PMA)--The PMA Supplement Decision-Making Process'' 
to the Division of Small Manufacturers, International, and Consumer 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For general questions: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010.
    For questions about the 30-day notice program or regarding 
manufacturing site changes: Christy Foreman, Center for Devices and 
Radiological Health (HFZ-340), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0120.
    For biologics issues: Leonard Wilson, Center for Biologics 
Evaluation and Research (HFM-25), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to help the regulated industry 
determine whether submitting a PMA supplement or other notification to 
FDA is required for class III devices subject to PMA. FDA developed 
this draft guidance to address modifications to device design, device 
labeling, and the device manufacturing process. This guidance also can 
be applied when a legally marketed class III device is the subject of a 
recall or field corrective action and the manufacturer needs to change 
the device to assure its safety and effectiveness. This draft guidance 
is intended to apply to the device portion of combination products such 
as drug/device or biologic/device combinations.

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 
modifications to devices subject to PMA applications. 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. To receive ``Modifications to Devices Subject 
to Premarket Approval (PMA)--The PMA Supplement Decision-Making 
Process,'' 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 
240-276-3151 to receive a hard copy. Please use the document number 
1584 to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft 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 USC 3501-3520) (the PRA). 
The collections of information addressed in the draft guidance document 
have been approved by OMB in accordance with the PRA under the 
regulations governing PMA applications (21 CFR part 814, OMB control 
number 0910-0231).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that

[[Page 14283]]

individuals may submit one paper copy. Comments are to be identified 
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: March 16, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-5572 Filed 3-26-07; 8:45 am]
BILLING CODE 4160-01-S

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