Agency Information Collection Activities: Proposed Collection Comment Request, 33233-33234 [E7-11557]
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33233
Federal Register / Vol. 72, No. 115 / Friday, June 15, 2007 / Notices
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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.
Label Comprehension Study (U.S.C.
393(d)(2)(C))
FDA issued the ‘‘Draft Guidance for
Industry and FDA Staff: Class II Special
Controls Guidance Document: Labeling
for Male Condoms Made of Natural
Rubber Latex’’ on November 14, 2005
(70 FR 69156). Section 21 U.S.C.
393(d)(2)(C) of the Federal Food, Drug
and Cosmetic Act (the act) states that
the Secretary, through the
Commissioner, shall be responsible to
conduct research relating to * * *
devices in carrying out this chapter. In
order to evaluate the understandability
of the condom labeling language
currently on the market and the labeling
language proposed in this draft
guidance, as well as a future revised
version of the labeling, FDA plans to
evaluate readers’ comprehension of
three versions of condom labeling
through a label comprehension study.
The proposed label comprehension
study will measure current and
potential condom consumers’
understanding of the current market
labeling and the proposed condom
labeling in the draft guidance of the
retail package, foil and package insert of
condom labeling, as well as a future
revised version of the labeling. The label
comprehension study will follow a
sequential design, first testing both the
current market labeling (Part A) and the
draft labeling in the guidance (Part B) in
Stage 1, and then a revised version of
the labeling in Stage 2.
FDA will conduct a label
comprehension study via a mall
intercept/central location intercept
methodology with pre-screened
participants. The FDA will administer a
screening instrument, the Rapid
Estimate of Adult Literacy in Medicine
(REALM) test, an informed consent, and
a questionnaire with approximately 20
questions related to the condom labeling
language to a total of 1,200 participants:
400 participants for Part A of Stage 1,
400 participants for Part B of Stage 1,
and 400 participants for Stage 2 of the
study. Results of the study will be
considered in FDA’s condom labeling
recommendations to provide important
risk/benefit and use information
associated with condoms in an easily
understood language.
In the Federal Register of February
16, 2007 (72 FR 7661), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Screening Tool
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
3,300
1
3,300
.05
165
Stage 1: Part A REALM test; Informed Consent;
Read Labeling;
Questionnaire
400
1
400
.45
180
Stage 1: Part B REALM test; Informed Consent;
Read Labeling;
Questionnaire
400
1
400
.45
180
Stage 2 - REALM
test; Informed
Consent; Read
Labeling; Questionnaire
400
1
400
.45
180
Total
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1 There
705
are no capital costs or operating and maintenance costs associated with this collection of information.
This was based on similar types of
FDA studies conducted in the past. FDA
has conducted both focus group studies
and label comprehension studies, where
similar participant activities, such as
reading the labeling, taking the REALM
test, signing the informed consent, and
answering questions on a selfadministered questionnaire took place.
In order to achieve the 1,200
participants for the condom label
comprehension study, FDA estimates
screening 3,300 to achieve 1,200
interviews.
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19:26 Jun 14, 2007
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Dated: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11528 Filed 6–14–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
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33234
Federal Register / Vol. 72, No. 115 / Friday, June 15, 2007 / Notices
L. 104–13), the Health Resources and
Services Administration (HRSA) will
publish periodic summaries of proposed
projects being developed for submission
to OMB under the Paperwork Reduction
Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans, call the HRSA Reports Clearance
Officer on (301) 443–1129.
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
of other forms of information
technology.
Proposed Project: The Nursing
Education Loan Repayment Program
Application (OMB No. 0915–0140)—
Revision
This is a request for revision of the
Nursing Education Loan Repayment
Program (NELRP) application and
participant monitoring forms. The
NELRP was originally authorized by 42
U.S.C. 297b(h) (section 836(h) of the
Public Health Service Act) as amended
by Public Law 100–607, November 4,
1988. The NELRP is currently
authorized by 42 U.S.C. 297n (section
846 of the Public Health Service Act) as
amended by Public Law 107–205,
August 1, 2002.
Under the NELRP, registered nurses
are offered the opportunity to enter into
a contractual agreement with the
Secretary to receive loan repayment for
Responses
per
respondents
Number of
respondents
Form
Estimates of Annualized Hour Burden are as Follows for
Applicants:
NELRP Application .....................................................
Loan Verification Form ...............................................
Applicant Employment Verification Form ...................
Payment Information Form .........................................
Application Checklist ...................................................
Pre-Award Confirmation Checklist ..............................
up to 85 percent of their qualifying
educational loan balance as follows: 30
percent each year for the first 2 years
and 25 percent for the third year. In
exchange, the nurses agree to serve fulltime as a registered nurse for 2 or 3
years at a health care facility with a
critical shortage of nurses.
NELRP requires the following
information:
1. Applicants must provide
information on their nursing education,
employment, and proposed service site;
2. Applicants must provide
information on their outstanding
nursing educational loans;
3. Applicants must provide banking
information from their financial
institution; and
4. Employers must provide
information on the health care facility
and on the employment status of
applicants and participants.
Total
responses
Hours per
response
Total burden
hours
5,000
5,000
5,000
5,000
5,000
600
1
3
1
1
1
1
5,000
15,000
5,000
5,000
5,000
600
1.5
1
.5
1
.5
.25
7,500
15,000
2,500
5,000
2,500
150
Total .....................................................................
Estimates of Annualized Hour Burden are as Follows for
Participants:
Participant Semi-Annual Employment Verification
Form ........................................................................
5,000
........................
35,600
..........................
32,650
1,300
2
2,600
.5
1,300
Total .....................................................................
1,300
2
2,600
.5
1,300
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33 Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857. Written comments should be
received with 60 days of this notice.
Dated: June 11, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–11557 Filed 6–14–07; 8:45 am]
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BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission of Childhood
Vaccines; Request for Nominations for
Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill three
vacancies on the Advisory Commission
on Childhood Vaccines (ACCV). The
ACCV was established by Title XXI of
the Public Health Service Act (the Act),
as enacted by Public Law (Pub. L.) 99–
660 and as subsequently amended, and
advises the Secretary of Health and
VerDate Aug<31>2005
19:26 Jun 14, 2007
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Human Services (the Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP).
DATES: The agency must receive
nominations on or before July 16, 2007.
ADDRESSES: All nominations are to be
submitted to the Director, Division of
Vaccine Injury Compensation,
Healthcare Systems Bureau (HSB),
HRSA, Parklawn Building, Room 11C–
26, 5600 Fishers Lane, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Ms.
Delia Jones, Principal Staff Liaison,
Policy Analysis Branch, Division of
Vaccine Injury Compensation, HSB,
HRSA at (301) 443–6593 or e-mail:
djones2@hrsa.gov.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the ACCV,
the Federal Advisory Committee Act of
October 6, 1972 (Pub. L. 92–463) and
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]]>Agencies
[Federal Register Volume 72, Number 115 (Friday, June 15, 2007)]
[Notices]
[Pages 33233-33234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11557]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub.
[[Page 33234]]
L. 104-13), the Health Resources and Services Administration (HRSA)
will publish periodic summaries of proposed projects being developed
for submission to OMB under the Paperwork Reduction Act of 1995. To
request more information on the proposed project or to obtain a copy of
the data collection plans, call the HRSA Reports Clearance Officer on
(301) 443-1129.
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 of other
forms of information technology.
Proposed Project: The Nursing Education Loan Repayment Program
Application (OMB No. 0915-0140)--Revision
This is a request for revision of the Nursing Education Loan
Repayment Program (NELRP) application and participant monitoring forms.
The NELRP was originally authorized by 42 U.S.C. 297b(h) (section
836(h) of the Public Health Service Act) as amended by Public Law 100-
607, November 4, 1988. The NELRP is currently authorized by 42 U.S.C.
297n (section 846 of the Public Health Service Act) as amended by
Public Law 107-205, August 1, 2002.
Under the NELRP, registered nurses are offered the opportunity to
enter into a contractual agreement with the Secretary to receive loan
repayment for up to 85 percent of their qualifying educational loan
balance as follows: 30 percent each year for the first 2 years and 25
percent for the third year. In exchange, the nurses agree to serve
full-time as a registered nurse for 2 or 3 years at a health care
facility with a critical shortage of nurses.
NELRP requires the following information:
1. Applicants must provide information on their nursing education,
employment, and proposed service site;
2. Applicants must provide information on their outstanding nursing
educational loans;
3. Applicants must provide banking information from their financial
institution; and
4. Employers must provide information on the health care facility
and on the employment status of applicants and participants.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondents responses response hours
----------------------------------------------------------------------------------------------------------------
Estimates of Annualized Hour
Burden are as Follows for
Applicants:
NELRP Application........... 5,000 1 5,000 1.5 7,500
Loan Verification Form...... 5,000 3 15,000 1 15,000
Applicant Employment 5,000 1 5,000 .5 2,500
Verification Form..........
Payment Information Form.... 5,000 1 5,000 1 5,000
Application Checklist....... 5,000 1 5,000 .5 2,500
Pre-Award Confirmation 600 1 600 .25 150
Checklist..................
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Total................... 5,000 .............. 35,600 .............. 32,650
Estimates of Annualized Hour
Burden are as Follows for
Participants:
Participant Semi-Annual 1,300 2 2,600 .5 1,300
Employment Verification
Form.......................
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Total................... 1,300 2 2,600 .5 1,300
----------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville,
Maryland 20857. Written comments should be received with 60 days of
this notice.
Dated: June 11, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-11557 Filed 6-14-07; 8:45 am]
BILLING CODE 4165-15-P
