Agency Information Collection Activities: Proposed Collection: Comment Request, 16136-16137 [2010-7251]
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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
https://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.
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19:40 Mar 30, 2010
$50,000
100,000
110,000
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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
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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.
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19:40 Mar 30, 2010
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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 https://
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
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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:
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]]>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]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
