Published 60 Day FRN

21630

Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices

Dated: April 16, 2010.
Judith Sparrow,
Office of Programs and Coordination Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2010–9578 Filed 4–23–10; 8:45 am]
BILLING CODE 4150–45–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology; HIT
Policy Committee’s Workgroup
Meetings; Notice of Meetings
AGENCY: Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meetings.

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This notice announces forthcoming
subcommittee meetings of a Federal
advisory committee of the Office of the
National Coordinator for Health
Information Technology (ONC). The
meetings will be open to the public via
dial-in access only.
Name of Committees: HIT Policy
Committee’s Workgroups: Meaningful Use,
Privacy & Security Policy, Strategic Plan,
Adoption/Certification, and Nationwide
Health Information Infrastructure (NHIN)
workgroups.
General Function of the Committee: To
provide recommendations to the National
Coordinator on a policy framework for the
development and adoption of a nationwide
health information technology infrastructure
that permits the electronic exchange and use
of health information as is consistent with
the Federal Health IT Strategic Plan and that
includes recommendations on the areas in
which standards, implementation
specifications, and certification criteria are
needed.
Date and Time: The HIT Policy Committee
Workgroups will hold the following public
meetings during May 2010: May 4th
Meaningful Use Workgroup, 10 a.m. to 12
p.m./ET; May 7th Privacy & Security Policy
Workgroup, 2 p.m. to 4 p.m./ET; May 10th
NHIN Workgroup, 10 a.m. to 1 p.m./ET; and
May 11th Strategic Plan Workgroup, 9 a.m.
to 11 a.m./ET.
Location: All workgroup meetings will be
available via webcast; for instructions on
how to listen via telephone or Web visit
http://healthit.hhs.gov. Please check the ONC
Web site for additional information as it
becomes available.
Contact Person: Judy Sparrow, Office of the
National Coordinator, HHS, 330 C Street,
SW., Washington, DC 20201, 202–205–4528,
Fax: 202–690–6079, e-mail:
[email protected]. Please call the contact
person for up-to-date information on these
meetings. A notice in the Federal Register
about last minute modifications that affect a
previously announced advisory committee
meeting cannot always be published quickly
enough to provide timely notice.

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Agenda: The workgroups will be
discussing issues related to their specific
subject matter, e.g., meaningful use, the
NHIN, privacy and security policy, adoption/
certification, or strategic planning. If
background materials are associated with the
workgroup meetings, they will be posted on
ONC’s Web site prior to the meeting at
http://healthit.hhs.gov.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
workgroups. Written submissions may be
made to the contact person on or before two
days prior to the workgroups’ meeting date.
Oral comments from the public will be
scheduled at the conclusion of each
workgroup meeting. Time allotted for each
presentation will be limited to three minutes.
If the number of speakers requesting to
comment is greater than can be reasonably
accommodated during the scheduled open
public session, ONC will take written
comments after the meeting until close of
business on that day.
If you require special accommodations due
to a disability, please contact Judy Sparrow
at least seven (7) days in advance of the
meeting.
ONC is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at http://healthit.hhs.gov
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (Pub. L. 92–
463, 5 U.S.C., App. 2).
Dated: April 16, 2010.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2010–9579 Filed 4–23–10; 8:45 am]
BILLING CODE 4150–45–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–09BC]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Maryam Daneshvar, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an e-mail to [email protected].

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Comments are invited on: (a) Whether
the proposed collection of information
is 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Exploring HIV Prevention
Communication Among Black Men Who
Have Sex with Men In New York City:
Project BROTHA—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and Tuberculosis Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is requesting OMB approval to
administer a survey, conduct interviews
and offer HIV rapid testing in Black Men
who have sex with Men (BMSM) and
other Men who have Sex with Men
(MSM) in New York City. The purpose
of the proposed study is to assess how
interpersonal communication within
BMSM social networks may be related
to risk for HIV infection and attitudes
towards HIV testing.
Data collection will occur over the
course of 2–3 years. After screening for
eligibility, a total of 300 BMSM and
other MSM in their social networks will
be enrolled in 2 phases: (1) 350 BMSM
will be recruited and screened to find
100 eligible BMSM participants, and (2)
the 100 first phase participants will then
recruit 200 other MSM within their
social networks to participate in the
second phase. Quantitative surveys will
be administered by computers and
personal interviews will be conducted
to collect qualitative data (at baseline
and 3-month follow-up). Participants in
both phases will be offered rapid HIV
testing, and declining an HIV test will
not negatively impact their study
participation. The research questions
being explored are relevant for
understanding how interpersonal
communication with members of one’s
social networks are related to risk for
contracting HIV infection and attitudes
towards HIV testing.
This study will provide important
epidemiologic information useful for the
development of HIV prevention

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21631

Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices
interventions for BMSM. Men will
complete a 5-minute eligibility
screening interview. The baseline
computer-based survey will take 45
minutes. The qualitative interview will
take approximately 75 minutes. The

number of respondents who will accept
HIV testing is estimated to be 200
(accounting for those who did not test
at baseline and those who do not
consent to test at follow-up). HIV
counseling and rapid testing will take

45 minutes. The 3-month follow-up
survey will take approximately 30
minutes; the follow-up qualitative
interview will take approximately 45
minutes. There is no cost to the
respondents other than their time.

ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of responses per
respondent

Screening interview ..........................
ACASI survey interview ...................

750
300

1
1

5/60
45/60

63
225

Qualitative interview .........................
HIV testing & counseling ..................
ACASI survey interview ...................

300
200
300

1
1
1

1.25
45/60
30/60

375
150
150

Qualitative interview .........................
HIV testing & counseling ..................

300
200

1
1

45/60
45/60

225
150

Total Burden Hours ..........................

........................

........................

........................

1338

Form name

BMSM respondents only ...................
BMSM and other MSM respondents:
Baseline.
BMSM and other MSM respondents:
3 month follow-up.

Dated: April 19, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–9606 Filed 4–23–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0070]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Agreement for
Shipment of Devices for Sterilization
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 26,
2010.

To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
[email protected]. All
comments should be identified with the

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ADDRESSES:

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16:56 Apr 23, 2010

Average
burden per
response
(in hours)

Number of respondents

Respondents

Jkt 220001

OMB control number 0910–0131. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, [email protected].
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150(e) (OMB
Control Number 0910–0131)—Extension
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations in § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms. Under § 801.150(e)(1),
manufacturers and sterilizers may sign
an agreement containing the following:
(1) Instructions for maintaining
accountability of the number of units in
each shipment; (2) acknowledgment that
the devices that are nonsterile are being
shipped for further processing; and (3)

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Total burden
(in hours)

specifications for sterilization
processing. This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices (§ 801.150(a)(2)). The
respondents to this collection of
information are device manufacturers
and contact sterilizers. FDA’s estimate
of the reporting burden is based on
actual data obtained from industry over
the past several years where there are
approximately 90 firms subject to this
requirement. It is estimated that each of
these firms on the average prepares 20
written agreements each year. This
estimate varies greatly, from 1 to 100,
because some firms provide sterilization
services on a part time basis for only
one customer while others are large
facilities with many customers. The
average time required to prepare each
written agreement is estimated to be 4
hours. This estimate varies depending
on whether the agreement is the initial
agreement or an annual renewal, on the
format each firm elects to use, and on
the length of time required to reach
agreement. The estimate applies only to
those portions of the written agreement
that pertain to the requirements
imposed by this regulation. The written
agreement generally also includes
contractual agreements that are a
customary and usual business practice.
On the average, the total annual
recordkeeping burden is 7,200 hours (90
firms x 20 agreements x 4 hours). The

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