Attachment E - 60-Day Notice

1790

Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–0217]

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 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
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

States and the Federal government. This
data collection, authorized by 42 U.S.C.
242k, has been carried out by NCHS
since it was created in 1960.
NCHS assists in achieving the
comparability needed for combining
data from all States into national
statistics, by conducting a training
program for State and local vital
statistics staff to assist in developing
expertise in all aspects of vital
registration and vital statistics. The
training offered under this program
includes courses for registration staff,
statisticians, and coding specialists, all
designed to bring about a high degree of
uniformity and quality in the data
provided by the States. This training
program is authorized by 42 U.S.C.
242b, section 304(a). In order to offer the
types of training that would be most
useful to vital registration staff
members, NCHS requests information
from State and local vital registration
officials about their projected needs for
training. NCHS also asks individual
candidates for training to submit an
application form containing name,
address, occupation, work experience,
education, and previous training. These
data enable NCHS to determine those
individuals whose needs can best be
met through the available training
resources. NCHS is requesting 3 years of
OMB clearance for this project.
There is no cost to respondents in
providing these data.

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
Vital Statistics Training Application,
(OMB No. 0920–0217 exp. 7/31/2010)—
Extension—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
In the United States, legal authority
for the registration of vital events, i.e.,
births, deaths, marriages, divorces, fetal
deaths, and induced terminations of
pregnancy, resides individually with the
States (as well as cities in the case of
New York City and Washington, DC)
and Puerto Rico, the Virgin Islands,
Guam, American Samoa, and the
Commonwealth of the Northern Mariana
Islands. These governmental entities are
the full legal proprietors of vital records
and the information contained therein.
As a result of this State authority, the
collection of registration-based vital
statistics at the national level, referred
to as the U.S. National Vital Statistics
System (NVSS), depends on a
cooperative relationship between the

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

State, local, and Territory Registration Officials ..............................................
Training applicants ...........................................................................................

Number of
responses per
respondent

57
100

1
1

Total ..........................................................................................................

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2010–510 Filed 1–12–10; 8:45 am]

[Docket No. FDA–2009–D–0605]

srobinson on DSKHWCL6B1PROD with NOTICES

Food and Drug Administration

Draft Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors: IRB Continuing Review
After Clinical Investigation Approval;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled,

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Total burden
hours
19
25
44

Dated: January 7, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
BILLING CODE 4163–18–P

Average
burden per
response
(in hours)

‘‘Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB
Continuing Review After Clinical
Investigation Approval.’’ The draft
guidance announced in this notice is
intended to assist institutional review
boards (IRBs) in carrying out their
continuing review responsibility by
providing recommendations regarding
the criteria, process, and frequency of
continuing review to assure the
protection of the rights and welfare of
subjects in clinical investigations. The
draft guidance should also help clinical
investigators and sponsors better
understand their responsibilities related
to continuing review.

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