Agency Information Collection Activities: Proposed Collection Comment Request, 33233-33234 [E7-11557]

Download as PDF 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 Label Comprehension Study (U.S.C. 393(d)(2)(C)) FDA issued the ‘‘Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex’’ on November 14, 2005 (70 FR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understandability of the condom labeling language currently on the market and the labeling language proposed in this draft guidance, as well as a future revised version of the labeling, FDA plans to evaluate readers’ comprehension of three versions of condom labeling through a label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and potential condom consumers’ understanding of the current market labeling and the proposed condom labeling in the draft guidance of the retail package, foil and package insert of condom labeling, as well as a future revised version of the labeling.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 jlentini on PROD1PC65 with NOTICES 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. VerDate Aug<31>2005 19:26 Jun 14, 2007 Jkt 211001 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. Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1 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] jlentini on PROD1PC65 with NOTICES 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 Jkt 211001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 E:\FR\FM\15JNN1.SGM 15JNN1

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.

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                                     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..................
                                 -------------------------------------------------------------------------------
        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.......................
                                 -------------------------------------------------------------------------------
        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