Agency Information Collection Activities; Submission for OMB Review; Comment Request, 21983-21984 [2012-8797]
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Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices
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:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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16:27 Apr 11, 2012
Jkt 226001
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
21983
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
E:\FR\FM\12APN1.SGM
12APN1
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
Purpose of
submission
Number of
respondents
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.
Burden per
response
(hr.)
Responses per
respondent
Total Burden
(hrs.)
Initial Application for Waiver ............................................................
Notification to Prescribe Immediately ..............................................
Notice to Treat up to 100 patients ...................................................
1,500
50
500
1
1
1
.083
.083
.040
125
4
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
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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16:27 Apr 11, 2012
Jkt 226001
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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\12APN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Pages 21983-21984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8797]
-----------------------------------------------------------------------
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
[[Page 21984]]
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.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Burden per Total Burden
Purpose of submission respondents respondent response (hr.) (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
