Agency Information Collection Activities: Proposed Collection: Comment Request, 16136-16137 [2010-7251]

Download as PDF 16136 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name Total .......................................................................................................... Total burden hours 190 Average hourly wage rate ** 722 NA Total cost burden 31,046 * Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept of Labor, Bureau of Labor Statistics’ May 2008 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—located at http://www.bls.gov/oes/current/oes_nat.htm. ** Wage rate of $43.00 is based on the mean hourly wages for Medical and Health Services Managers. Wage rate of $42.67 is the weighted mean hourly wage for: Medical and Health Services Managers ($42.67 × 2.6 hours = $110.95), Lawyers ($59.98 × .5 hours = $29.99), Chief Executives ($89.16 × .5 hours = $44.58), and Computer programmer ($35.32 × 4 hours = $141.28) [Weighted mean = ($110.95 + 29.99 + 44.58 = 141.28)/7.6 hours = $326.80/7.6 hours = $43.00/hour]. Estimated Annual Costs to the Federal Government Exhibit 3 shows the estimated annualized cost to the government for developing, maintaining and managing the Health Plan Database and analyzing the data and reporting results. The cost is estimated to be $260,000 annually. Annualized costs for collecting and processing the CAHPS Health Plan Database are based upon 10 years of historical project costs. Start-up costs were present in the early years of the database only. EXHIBIT 3—ESTIMATED ANNUALIZED COST Cost component Dated: March 19, 2010. Carolyn M. Clancy, Director. [FR Doc. 2010–6780 Filed 3–30–10; 8:45 am] BILLING CODE 4160–90–M 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)(A) of Title 44, United States Code, as amended by the Total ............................... 260,000 Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Request for Comments Services Administration (HRSA) In accordance with the above-cited publishes periodic summaries of Paperwork Reduction Act legislation, proposed projects being developed for comments on AHRQ’s information submission to Office of Management collection are requested with regard to and Budget (OMB) under the Paperwork any of the following: (a) Whether the Reduction Act of 1995. To request more proposed collection of information is information on the proposed project or necessary for the proper performance of to obtain a copy of the data collection AHRQ healthcare research and plans and draft instruments, call the healthcare information dissemination HRSA Reports Clearance Officer on functions, including whether the (301) 443–1129. information will have practical utility; Comments are invited on: (a) Whether (b) the accuracy of AHRQ’s estimate of the proposed collection of information burden (including hours and costs) of is necessary for the proper performance the proposed collection(s) of of the functions of the agency, including information; (c) ways to enhance the whether the information shall have quality, utility, and clarity of the practical utility; (b) the accuracy of the information to be collected; and (d) agency’s estimate of the burden of the ways to minimize the burden of the proposed collection of information; (c) collection of information upon the ways to enhance the quality, utility, and respondents, including the use of clarity of the information to be automated collection techniques or collected; and (d) ways to minimize the other forms of information technology. burden of the collection of information Comments submitted in response to on respondents, including through the this notice will be summarized and included in the Agency’s subsequent use of automated collection techniques request for OMB approval of the or other forms of information proposed information collection. All technology. Database Maintenance ......... Data Submission .................. Data Analysis and Reporting jlentini on DSKJ8SOYB1PROD with NOTICES Annualized cost comments will become a matter of public record. VerDate Nov<24>2008 19:40 Mar 30, 2010 $50,000 100,000 110,000 Jkt 220001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Proposed Project: The Health Education Assistance Loan (HEAL) Program: Physician’s Certification of Borrower’s Total and Permanent Disability Form (OMB No. 0915–0204)—Extension The Health Education Assistance Loan (HEAL) program provided federally-insured loans to students in schools of allopathic medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, allied health, or chiropractic, and graduate students in health administration or clinical psychology through September 30, 1998. Eligible lenders, such as banks, savings and loan associations, credit unions, pension funds, State agencies, HEAL schools, and insurance companies, made new refinanced HEAL loans which are insured by the Federal Government against loss due to borrower’s death, disability, bankruptcy, and default. The basic purpose of the program was to assure the availability of funds for loans to eligible students who needed to borrow money to pay for their educational loans. Currently, the program monitors the federal liability, and assists in default prevention activities. The HEAL borrower, the borrower’s physician, and the holder of the loan completes the Physician’s Certification form to certify that the HEAL borrower meets the total and permanent disability provisions. The Department uses this form to obtain detailed information about disability claims which includes the following: (1) The borrower’s consent to release medical records to the Department of Health and Human Services and to the holder of the borrower’s HEAL loans, (2) pertinent information supplied by the certifying physician, (3) the physician’s certification that the borrower is unable to engage in any substantial gainful activity because of a medically determinable impairment that is expected to continue for a long and indefinite period of time or to result in death, and (4) information from the E:\FR\FM\31MRN1.SGM 31MRN1 16137 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices lender on the unpaid balance. Failure to submit the required documentation will result in disapproval of a disability claim. No changes have been made to the current form. Number of respondents Type of respondent Responses per respondent The estimate of burden for the Physician’s Certification form is as follows: Number of responses Minutes per response Total burden hours Borrower ............................................................................... Physician .............................................................................. Loan Holder ......................................................................... 75 75 13 1 1 6 75 75 78 5 30 10 6 38 13 Total .............................................................................. 163 ........................ 228 ........................ 57 E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: March 25, 2010. Sahira Rafiullah, Director, Division of Policy and Information Coordination. [FR Doc. 2010–7251 Filed 3–30–10; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0161] Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates AGENCY: Food and Drug Administration, HHS. jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA-regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended. VerDate Nov<24>2008 19:40 Mar 30, 2010 Jkt 220001 DATES: Submit written or electronic comments on the collection of information by June 1, 2010. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.Capezzuto@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Export of Food and Drug Administration Regulated Products: Export Certificates (OMB Control Number 0910–0498)—Extension In April 1996, a law entitled ‘‘The FDA Export Reform & Enhancement Act of 1996’’ (FDAERA) amended sections 801(e) and 802 of the act (21 U.S.C. 381(e) and 382). It was designed to ease restrictions on exportation of unapproved pharmaceuticals, biologics, and devices regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of 801(e) and 802 or other requirements of the act. This section of the law requires FDA to issue certification within 20 days of receipt of the request and to charge firms up to $175 for the certifications. This new section of the act authorizes FDA to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the act. FDA has developed five types of certificates that satisfy the requirements of section 801(e)(4)(B) of the act: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, (4) NonClinical Research Use Only Certificates, and (5) Certificates of Free Sale. Table 1 of this document lists the different certificates and details their use: E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16136-16137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7251]


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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)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to Office of Management and Budget (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 and draft instruments, 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 or other 
forms of information technology.

Proposed Project: The Health Education Assistance Loan (HEAL) Program: 
Physician's Certification of Borrower's Total and Permanent Disability 
Form (OMB No. 0915-0204)--Extension

    The Health Education Assistance Loan (HEAL) program provided 
federally-insured loans to students in schools of allopathic medicine, 
osteopathic medicine, dentistry, veterinary medicine, optometry, 
podiatric medicine, pharmacy, public health, allied health, or 
chiropractic, and graduate students in health administration or 
clinical psychology through September 30, 1998. Eligible lenders, such 
as banks, savings and loan associations, credit unions, pension funds, 
State agencies, HEAL schools, and insurance companies, made new 
refinanced HEAL loans which are insured by the Federal Government 
against loss due to borrower's death, disability, bankruptcy, and 
default. The basic purpose of the program was to assure the 
availability of funds for loans to eligible students who needed to 
borrow money to pay for their educational loans. Currently, the program 
monitors the federal liability, and assists in default prevention 
activities.
    The HEAL borrower, the borrower's physician, and the holder of the 
loan completes the Physician's Certification form to certify that the 
HEAL borrower meets the total and permanent disability provisions. The 
Department uses this form to obtain detailed information about 
disability claims which includes the following: (1) The borrower's 
consent to release medical records to the Department of Health and 
Human Services and to the holder of the borrower's HEAL loans, (2) 
pertinent information supplied by the certifying physician, (3) the 
physician's certification that the borrower is unable to engage in any 
substantial gainful activity because of a medically determinable 
impairment that is expected to continue for a long and indefinite 
period of time or to result in death, and (4) information from the

[[Page 16137]]

lender on the unpaid balance. Failure to submit the required 
documentation will result in disapproval of a disability claim. No 
changes have been made to the current form.
    The estimate of burden for the Physician's Certification form is as 
follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per     Number of      Minutes per    Total burden
       Type of respondent           respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Borrower........................              75               1              75               5               6
Physician.......................              75               1              75              30              38
Loan Holder.....................              13               6              78              10              13
                                 -------------------------------------------------------------------------------
    Total.......................             163  ..............             228  ..............              57
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    E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports 
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857. Written comments should be received within 60 days 
of this notice.

    Dated: March 25, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-7251 Filed 3-30-10; 8:45 am]
BILLING CODE 4165-15-P