Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices 21983 

or nominated by an organization to 

serve as a nonvoting industry 

representative. Nominations will be 

accepted for current vacancies effective 

with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by May 14, 2012, for the vacancy 

listed in this notice. Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

May 14, 2012. 

ADDRESSES: All letters of interest and 

nominations should be submitted in 

writing to Bryan Emery (see: FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Bryan Emery, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike (HFM–71), Rockville, MD 20852– 

1448, 301–827–1277, Fax: 301–827– 

0294, email: bryan.emery@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative to the following 

advisory committee: 

I. Blood Products Advisory Committee 

for the Center for Biologics Evaluation 

and Research 

Members are selected by the 

Commissioner of Food and Drugs (the 

Commissioner) or designee from among 

authorities knowledgeable in the fields 

of clinical and administrative medicine, 

hematology, immunology, blood 

banking, surgery, internal medicine, 

biochemistry, engineering, biological 

and physical sciences, biotechnology, 

computer technology, statistics, 

epidemiology, sociology/ethics, and 

other related professions. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

III. Application Procedure 

Individuals may self nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current curriculum vitae, 

and the name of the committee of 

interest should be sent to the FDA 

contact person (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this document (see 

DATES). FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. Specifically, in this 

document, nominations for nonvoting 

representatives of industry interests are 

encouraged from the blood and blood 

products manufacturing industry. 

This notice is issued under the 

Federal Advisory Committee Act 

(5 U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: April 9, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8823 Filed 4–11–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities; Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Notification of Intent To Use 

Schedule III, IV, or V Opioid Drugs for 

the Maintenance and Detoxification 

Treatment of Opiate Addiction Under 

21 U.S.C. 823(g)(2) (OMB No. 0930– 

0234)—Extension 

The Drug Addiction Treatment Act of 

2000 (‘‘DATA,’’ Pub. L. 106–310) 

amended the Controlled Substances Act 

(21 U.S.C. 823(g)(2)) to permit 

practitioners (physicians) to seek and 

obtain waivers to prescribe certain 

approved narcotic treatment drugs for 

the treatment of opiate addiction. The 

legislation sets eligibility requirements 

and certification requirements as well as 

an interagency notification review 

process for physicians who seek 

waivers. The legislation was amended 

in 2005 to eliminate the patient limit for 

physicians in group practices, and in 

2006, to permit certain physicians to 

treat up to 100 patients. 

To implement these provisions, 

SAMHSA developed a notification form 

(SMA–167) that facilitates the 

submission and review of notifications. 

The form provides the information 

necessary to determine whether 

practitioners (i.e., independent 

physicians) meet the qualifications for 

waivers set forth under the new law. 

Use of this form will enable physicians 

to know they have provided all 

information needed to determine 

whether practitioners are eligible for a 

waiver. 

However, there is no prohibition on 

use of other means to provide requisite 

information. The Secretary will convey 

notification information and 

determinations to the Drug Enforcement 

Administration (DEA), which will 

assign an identification number to 

qualifying practitioners; this number 

will be included in the practitioner’s 

registration under 21 U.S.C. 823(f). 

Practitioners may use the form for 

three types of notification: (a) New, (b) 

immediate, and (c) to notify of their 

intent to treat up to 100 patients. Under 

‘‘new’’ notifications, practitioners may 

make their initial waiver requests to 

SAMHSA. ‘‘Immediate’’ notifications 

inform SAMHSA and the Attorney 

General of a practitioner’s intent to 

prescribe immediately to facilitate the 

treatment of an individual (one) patient 

under 21 U.S.C. 823(g)(2)(E)(ii). Finally, 

the form may be used by physicians 

with waivers to certify their need and 

intent to treat up to 100 patients. 

The form collects data on the 

following items: Practitioner name; state 

medical license number and DEA 

registration number; address of primary 

location, telephone and fax numbers; 

email address; name and address of 

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21984 Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices 

group practice; group practice employer 

identification number; names and DEA 

registration numbers of group 

practitioners; purpose of notification 

new, immediate, or renewal; 

certification of qualifying criteria for 

treatment and management of opiate 

dependent patients; certification of 

capacity to refer patients for appropriate 

counseling and other appropriate 

ancillary services; certification of 

maximum patient load, certification to 

use only those drug products that meet 

the criteria in the law. The form also 

notifies practitioners of Privacy Act 

considerations, and permits 

practitioners to expressly consent to 

disclose limited information to the 

SAMHSA Buprenorphine Physician 

Locator. 

Since July 2002, SAMHSA has 

received over 25,000 notifications and 

has certified almost 27,000 physicians. 

Fifty-one percent of the notifications 

were submitted by mail or by facsimile, 

with approximately forty-one percent 

submitted through the Web based online 

system. Approximately 60 percent of the 

certified physicians have consented to 

disclosure on the SAMHSA 

Buprenorphine Physician Locator. 

Respondents may submit the form 

electronically, through a dedicated Web 

page that SAMHSA will establish for the 

purpose, as well as via U.S. mail. 

There are no changes to the forms and 

burden hours. 

The following table summarizes the 

estimated annual burden for the use of 

this form. 

Purpose of 

submission 

Number of 

respondents 

Responses per 

respondent 

Burden per 

response 

(hr.) 

Total Burden 

(hrs.) 

Initial Application for Waiver ............................................................ 1,500 1 .083 125 

Notification to Prescribe Immediately .............................................. 50 1 .083 4 

Notice to Treat up to 100 patients ................................................... 500 1 .040 20 

Total ................................................................................................. 2,050 ............................ ............................ 149 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by May 14, 2012, to the 

SAMHSA Desk Officer at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB). To ensure timely receipt of 

comments, and to avoid potential delays 

in OMB’s receipt and processing of mail 

sent through the U.S. Postal Service, 

commenters are encouraged to submit 

their comments to OMB via email to: 

OIRA_Submission@omb.eop.gov. 

Although commenters are encouraged to 

send their comments via email, 

commenters may also fax their 

comments to: 202–395–7285. 

Commenters may also mail them to: 

Office of Management and Budget, 

Office of Information and Regulatory 

Affairs, New Executive Office Building, 

Room 10102, Washington, DC 20503. 

Summer King, 

Statistician. 

[FR Doc. 2012–8797 Filed 4–11–12; 8:45 am] 

BILLING CODE 4162–20–P 

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: Minority AIDS 

Initiative (MAI) Rapid HIV Testing 

Clinical Information Form (OMB No. 

0930–0295)—Revision 

This request is for a three-year generic 

clearance to continue rapid HIV testing 

data collection among 63 TCE–HIV 

Grantees and their clients and the 

additional 11 MAI–HIV Grantees and 

their clients. The primary purpose of the 

MAI Rapid HIV Testing Clinical 

Information Form is to use a 

standardized data collection instrument 

to fully capture essential clinical 

information to enhance preventive 

services for those who test HIV-negative 

and refer to quality treatment/medical 

care those who test HIV-positive. 

The aim of the project is to implement 

and increase rapid HIV testing among 

racial and ethnic minorities and collect 

rapid HIV testing data using the MAI 

Rapid HIV Testing Clinical Information 

Form. To meet this requirement, all 

Grantees must offer their clients rapid 

HIV preliminary antibody testing during 

outreach, pretreatment, or program 

enrollment. In addition, rapid HIV 

testing may be made available to the 

sexual and/or injection partners of 

clients. Grantees must provide onsite 

rapid HIV testing in accordance with 

their respective State and local 

requirements. If a client requests an offsite rapid HIV test, the Grantee must 

provide a referral to a rapid HIV testing 

site certified by the local health 

department. 

Grantees are currently using the MAI 

Rapid HIV Testing Clinical Information 

Form in the field to systematically 

collect information from clients on 

demographics, previous rapid HIV test 

results, substance use and sexual risk 

behaviors, current rapid HIV test results, 

types of services received, and 

confirmatory HIV test result. Once a 

client is offered a rapid HIV test, the 

Grantee staff completes the MAI Rapid 

HIV Testing Clinical Information Form 

with the client present and then enters 

the data into a secure Web site that 

allows for real-time data submission. 

The estimated annualized burden is 

summarized below. 

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