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Draft Guidance for Industry and Food 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. 

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availability of the draft guidance 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 This draft guidance is 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 This draft guidance is not final 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comments on this draft guidance by 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single copies of the draft guidance 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 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 http:// 

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 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

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 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

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 

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. 

Proposed Project: Independent 

Evaluation of the Substance Abuse 

Prevention and Treatment Block Grant 

Program—NEW 

The Substance Abuse and Mental 

Health Services Administration 

(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.Not less than 35 percent of SAPT BG funding.* 

Prevention and treatment activities regarding 

other drugs.

Not less than 35 percent of SAPT BG funding.* 

Primary prevention programs ............................. Not less than 20 percent of SAPT BG funding. 

Pregnant women and women with dependent 

children.

Not less than amount equal to expenditure in FY1994. 

Tuberculosis services ......................................... No set amount but services must be provided to receive SAPT BG funds. 

HIV services b ..................................................... No more than 5 percent increase over State allotment for HIV services in FY 1991. 

Prohibition of sale of tobacco to individuals 

under age of 18 (Synar amendment).

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. 

Maintenance of effort (MOE) for State expenditures.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. 

Administrative expenses .................................... Limited to 5 percent of SAPT BG funding. 

aThese 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. bFor 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

GOAL #1: Continuum of substance abuse treatment services.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)). 

GOAL #2: Spending on primary prevention programs.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)). 


sroberts on PROD1PC70 with NOTICES