Agency Information Collection Activities; Proposed Collection; Comment Request, 18988-18989 [2013-07190]
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18988
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Ave., Bldg. 66, Rm. 5508, Silver Spring,
MD 20993, 301–796–6203.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2010–D–0636]
I. Background
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies
to Borrelia burgdorferi; Guidance for
Industry and Food and Drug
Administration Staff; Availability
This guidance recommends studies
for establishing the performance
characteristics of in vitro diagnostic
devices for the detection of antibodies to
B. burgdorferi in human serum, plasma,
and blood. These devices are used to aid
in the diagnosis of Lyme disease. This
document does not apply to B.
burgdorferi nucleic acid amplification
assays. A manufacturer who intends to
market an in vitro device for the
detection of antibodies to B. burgdorferi
must conform to the general controls of
the Federal Food, Drug, and Cosmetic
Act and, unless exempt, obtain
premarket clearance or approval prior to
marketing the device.
The draft guidance was announced in
the Federal Register of January 5, 2011
(76 FR 570), and the comment period
closed on April 5, 2011. No comments
were received during the comment
period.
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies
to Borrelia burgdorferi.’’ FDA is issuing
this guidance to provide industry and
Agency staff with recommendations for
studies to establish the analytical and
clinical performance of in vitro
diagnostic devices (IVDs) intended for
the detection of antibodies to B.
burgdorferi. These devices are used to
aid in the diagnosis of Lyme disease.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies
to Borrelia burgdorferi’’ to the Division
of Small Manufacturers, International
and Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Prasad Rao, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
VerDate Mar<15>2010
20:20 Mar 27, 2013
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II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on establishing the
performance characteristics of in vitro
diagnostic devices for the detection of
antibodies to B. burgdorferi. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 801 and 21
CFR 809.10 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 42 CFR
493.15 have been approved under OMB
control number 0910–0598; the
collections of information 21 CFR 50.23
have been approved under OMB control
number 0910–0586; and the collections
of information in 21 CFR 56.115 have
been approved under OMB control
number 0910–0130.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
III. Electronic Access
[FR Doc. 2013–07085 Filed 3–27–13; 8:45 am]
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies
to Borrelia burgdorferi,’’ you may either
send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1721 to identify the guidance
you are requesting.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
SUMMARY: 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
E:\FR\FM\28MRN1.SGM
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Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Notices
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the 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, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
The Health Education Assistance Loan
(HEAL) Program: Physician’s
Certification of Borrower’s Total and
Permanent Disability Form (OMB No.
0915–0204)–Extension
Abstract: The Health Education
Assistance Loan (HEAL) program
provided federally-insured loans to
students in schools of allopathic
medicine, osteopathic medicine,
dentistry, veterinary medicine,
Type of
respondent
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
complete 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
Number of
respondents
Borrower ................................................
Physician ................................................
Holder of Loan .......................................
Total ................................................
75
75
13
163
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
ADDRESSES:
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: March 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–07190 Filed 3–27–13; 8:45 am]
BILLING CODE 4165–15–P
Number of
responses per
respondent
20:20 Mar 27, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ryan White HIV/AIDS Program, Part C
Early Intervention Services Grant
Under the Ryan White HIV/AIDS
Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of Ryan White HIV/AIDS
Program Part C Early Intervention
Services One-Time Noncompetitive
Award to Ensure Continued HIV
Primary Medical Care.
AGENCY:
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Average
burden per
response
(in hours)
75
75
78
228
SUMMARY: To prevent a lapse in
comprehensive primary care services for
VerDate Mar<15>2010
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
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.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total
responses
1
1
6
..............................
18989
Total
burden
hours
.08
.5
.17
..............................
6
38
13
57
persons living with HIV/AIDS, HRSA
will provide a one-time noncompetitive
Part C funds award to the University of
Alabama at Birmingham (UAB).
SUPPLEMENTARY INFORMATION: The
amount of the award to ensure ongoing
HIV medical services is $1,283,907.
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51
CFDA Number: 93.918.
Project period: The period of support
for this award is 17 months, explained
below in further detail.
Justification for the Exception To
Competition: The Jefferson County
Commission, Birmingham, AL (Grant
Number: H76HA00098) announced the
relinquishment of their Part C grant on
January 31, 2013. To prevent a lapse in
HIV medical care to the service area
covered by that grant, grant funds of
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]]>Agencies
[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Pages 18988-18989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 18989]]
and Services Administration (HRSA) publishes periodic summaries of
proposed projects being developed for submission to the 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, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301)
443-1984.
HRSA especially requests comments on: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
Information Collection Request Title: The Health Education
Assistance Loan (HEAL) Program: Physician's Certification of Borrower's
Total and Permanent Disability Form (OMB No. 0915-0204)-Extension
Abstract: 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 complete 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
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.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per Total responses per response (in Total burden
respondents respondent hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Borrower................................................. 75 1 75 .08 6
Physician................................................ 75 1 75 .5 38
Holder of Loan........................................... 13 6 78 .17 13
Total................................................ 163 ................. 228 ................. 57
--------------------------------------------------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: March 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-07190 Filed 3-27-13; 8:45 am]
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