Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Availability, 50214-50215 [E9-23521]
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50214
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
2011. A copy of the Committee charter
can be obtained by contacting the
Committee’s Executive Secretary. A
copy of the Committee charter also can
be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The Web site address
for the FACA database is https://fido.gov/
facadatabase.
Dated: September 23, 2009.
Penelope Slade-Sawyer,
RADM, USPHS, Deputy Assistant Secretary
for Health (Disease Prevention and Health
Promotion), Office of Disease Prevention and
Health Promotion.
[FR Doc. E9–23539 Filed 9–29–09; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0434]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Humanitarian Device Exemption
Holders, Institutional Review Boards,
Clinical Investigators, and Food and
Drug Administration Staff:
Humanitarian Device Exemption
Regulation: Questions and Answers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 30,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title Guidance for Humanitarian Device
Exemption Holders, Institutional
Review Boards, Clinical Investigators,
and FDA Staff: Humanitarian Device
Exemption Regulation: Questions and
Answers; Availability. Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Guidance for Humanitarian Device
Exemption Holders, Institutional
Review Boards, Clinical Investigators,
and FDA Staff: Humanitarian Device
Exemption Regulation: Questions and
Answers—(OMB Control Number 0910–
NEW)
Title III of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85)
amended chapter V of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 351 et seq.) by inserting section
515A, Pediatric Uses of Devices (21
U.S.C. 360e–1).
This new provision requires that new
applications under section 520(m) of the
act (21 U.S.C. 360j(m)) include both a
description of any pediatric
subpopulation that suffer from: (1) A
disease or condition that the device is
intended to treat, diagnose, or cure and
(2) the number of affected pediatric
patients.
Title III of FDAAA also amended
section 520(m) of the act as follows:
Section 520(m)(6)(A)(ii) of the act
provides that the Secretary of Health
and Human Services will assign an
annual distribution number (ADN) for
devices indicated for use in a pediatric
population or in a pediatric
subpopulation. The ADN shall be based
on the following information in a
humanitarian device exemption (HDE)
application: (1) The number of
individuals affected by the disease or
condition that such device is intended
to treat, diagnose, or cure and of that
number; (2) the number of individuals
likely to use the device and (3) the
number of devices reasonably necessary
to to treat such individuals.
Section 520(m)(6)(A)(iii) of the act
provides that an HDE holder
immediately notify the agency if the
number of devices distributed during
any calendar year exceeds the ADN.
Section 520(m)(6)(C) of the act
provides that an HDE holder may
petition to modify the ADN if additional
information on the number of
individuals affected by the disease or
condition arises.
In the Federal Register of August 5,
2008 (73 FR 45460), FDA published a
60-day notice requesting public
comment on the information collection
provisions. Seven comments were
received in response to the 60-day
notice. Of the seven comments received,
six related to the guidance and the
information collection requests. We
received one comment that did not
address the content of the guidance nor
the information collection.
There were a number of comments
received that clarified the reporting
requirements for HDE holders and
institutional review boards (IRBs). In
response to these comments, FDA
responded by referring to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
803.50 have been approved under OMB
control number 0910–0437 and the
collections of information in part 814
(21 CFR part 814) have been approved
under OMB control number 0910–0332.
FDA received comments that sought
clarification regarding how an IRB
distinguishes between the use of a
humanitarian use device (HUD) and the
study of an HUD in a clinical
investigation. FDA responded by
providing additional background
information related to the collection of
safety and effectiveness information
related to clinical investigation for HDE
approved indications and referring to
previously approved collections of
information found in FDA regulations.
This collection of information is
approved under OMB control number
0910–0078.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Federal Food, Drug,
and Cosmetic Act
No. of
Respondents
515A(a)(2)
VerDate Nov<24>2008
Annual Frequency
per Response
5
14:56 Sep 29, 2009
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Frm 00053
Total Annual
Responses
1
Fmt 4703
Sfmt 4703
Hours per
Response
5
E:\FR\FM\30SEN1.SGM
Total Hours
100
30SEN1
500
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
50215
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Section of the Federal Food, Drug,
and Cosmetic Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
520(m)(6)(A)(ii)
3
1
3
50
150
520(m)(6)(A)(iii)
1
1
1
100
100
520(m)(6)(C)
5
1
5
100
500
Total
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
1There
1,250
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of original HDE applications
that the Center for Devices and
Radiological Health (CDRH) received in
the period between October 1, 2004, and
September 30, 2007. During that time,
CDRH received 16 original HDE
applications or about 5 per year.
FDA estimates that for each year,
CDRH will receive five HDE
applications and that three of these
applications will be indicated for
pediatric use. One HDE holder will
notify the agency that the number of
devices distributed in the year has
exceeded the ADN and five HDE holders
will petition to have the ADN modified
due to additional information on the
number of individuals affected by the
disease of condition.
The draft guidance refers also to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 803 have been approved under
OMB control number 0910–0437; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; 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 part
814, subparts A, B, and C have been
approved under OMB control number
0910–0231; the collection of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in part 814, subpart H have
been approved under OMB control
number 0910–0332; and the collection
of information requirements in 21 CFR
10.30 have been approved under OMB
control number 0910–0183.
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23521 Filed 9–29–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
14:56 Sep 29, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Immortalized Transformed
Lymphoblastoid Cell Lines From
Patients with Francois-Neetens
¸
´
Mouchetee Fleck Corneal Dystrophy
(CFD)
Description of Invention: Researchers
at the National Eye Institute, NIH, have
made available a set of immortalized
transformed lymphoblastoid cell lines
created from human T-lymphocytes
obtained from patients with Francois¸
´
Neetens Mouchetee Fleck Corneal
Dystrophy (CFD). The cells were
transformed with defective Epstein-Barr
virus using established methods.
CFD is a rare, autosomal dominant
corneal dystrophy characterized by
numerous small white flecks scattered
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
in all layers of the stroma. CFD has been
associated with mutations in the PIP5K3
protein, which is important for postGolgi vesicle processing.
Applications:
• Useful in the study of proteins
expressed by lymphocytes, including in
some cases the protein encoded by the
mutant gene KCNJ13.
• Useful as a renewable source of
DNA for genetic studies related to CFD
or the PIP5K3 protein.
Inventors: J. Fielding Hejtmancik and
Xiaodong Jiao (NEI).
Relevant Publications:
1. S Li et al. Mutations in PIP5K3 are
associated with Francois-Neetens
¸
´
mouchetee fleck corneal dystrophy. Am
J Hum Genet. 2005 Jul;77(1):54–63.
2. X Jiao et al. Genetic linkage of
´
Francois-Neetens fleck (mouchetee)
corneal dystrophy to chromosome 2q35.
Hum Genet. 2003 May; 112(5–6):593–
599.
Patent Status: HHS Reference No. E–
270–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a biological material
license.
Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Novel Chemoattractant-Based Toxins to
Improve Vaccine Immune Responses
for Cancer and Infectious Diseases
Description of Invention: Cancer is
one of the leading causes of death in
United States and it is estimated that
there will be more than half a million
deaths caused by cancer in 2009. A
major drawback of the current
chemotherapy-based therapeutics is the
cytotoxic side-effects associated with
them. Thus there is a dire need to
develop new therapeutic strategies with
fewer side-effects. Immunotherapy has
taken a lead among the new therapeutic
approaches. Enhancing the innate
immune response of an individual has
been a key approach for the treatment
against different diseases such as cancer
and infectious diseases.
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50214-50215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0434]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Humanitarian Device Exemption Holders, Institutional Review Boards,
Clinical Investigators, and Food and Drug Administration Staff:
Humanitarian Device Exemption Regulation: Questions and Answers;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
30, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards, Clinical Investigators, and FDA Staff: Humanitarian
Device Exemption Regulation: Questions and Answers; Availability. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards, Clinical Investigators, and FDA Staff: Humanitarian
Device Exemption Regulation: Questions and Answers--(OMB Control Number
0910-NEW)
Title III of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 351 et seq.) by inserting
section 515A, Pediatric Uses of Devices (21 U.S.C. 360e-1).
This new provision requires that new applications under section
520(m) of the act (21 U.S.C. 360j(m)) include both a description of any
pediatric subpopulation that suffer from: (1) A disease or condition
that the device is intended to treat, diagnose, or cure and (2) the
number of affected pediatric patients.
Title III of FDAAA also amended section 520(m) of the act as
follows:
Section 520(m)(6)(A)(ii) of the act provides that the Secretary of
Health and Human Services will assign an annual distribution number
(ADN) for devices indicated for use in a pediatric population or in a
pediatric subpopulation. The ADN shall be based on the following
information in a humanitarian device exemption (HDE) application: (1)
The number of individuals affected by the disease or condition that
such device is intended to treat, diagnose, or cure and of that number;
(2) the number of individuals likely to use the device and (3) the
number of devices reasonably necessary to to treat such individuals.
Section 520(m)(6)(A)(iii) of the act provides that an HDE holder
immediately notify the agency if the number of devices distributed
during any calendar year exceeds the ADN.
Section 520(m)(6)(C) of the act provides that an HDE holder may
petition to modify the ADN if additional information on the number of
individuals affected by the disease or condition arises.
In the Federal Register of August 5, 2008 (73 FR 45460), FDA
published a 60-day notice requesting public comment on the information
collection provisions. Seven comments were received in response to the
60-day notice. Of the seven comments received, six related to the
guidance and the information collection requests. We received one
comment that did not address the content of the guidance nor the
information collection.
There were a number of comments received that clarified the
reporting requirements for HDE holders and institutional review boards
(IRBs). In response to these comments, FDA responded by referring to
previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 803.50 have been
approved under OMB control number 0910-0437 and the collections of
information in part 814 (21 CFR part 814) have been approved under OMB
control number 0910-0332. FDA received comments that sought
clarification regarding how an IRB distinguishes between the use of a
humanitarian use device (HUD) and the study of an HUD in a clinical
investigation. FDA responded by providing additional background
information related to the collection of safety and effectiveness
information related to clinical investigation for HDE approved
indications and referring to previously approved collections of
information found in FDA regulations. This collection of information is
approved under OMB control number 0910-0078.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Section of the Federal Food, Drug, and Cosmetic Act Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
515A(a)(2) 5 1 5 100 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 50215]]
520(m)(6)(A)(ii) 3 1 3 50 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(m)(6)(A)(iii) 1 1 1 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(m)(6)(C) 5 1 5 100 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the number of original HDE
applications that the Center for Devices and Radiological Health (CDRH)
received in the period between October 1, 2004, and September 30, 2007.
During that time, CDRH received 16 original HDE applications or about 5
per year.
FDA estimates that for each year, CDRH will receive five HDE
applications and that three of these applications will be indicated for
pediatric use. One HDE holder will notify the agency that the number of
devices distributed in the year has exceeded the ADN and five HDE
holders will petition to have the ADN modified due to additional
information on the number of individuals affected by the disease of
condition.
The draft guidance refers also to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 803 have been approved under OMB control number 0910-
0437; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; 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 part 814,
subparts A, B, and C have been approved under OMB control number 0910-
0231; the collection of information in 21 CFR parts 50 and 56 have been
approved under OMB control number 0910-0130; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in part 814, subpart H
have been approved under OMB control number 0910-0332; and the
collection of information requirements in 21 CFR 10.30 have been
approved under OMB control number 0910-0183.
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23521 Filed 9-29-09; 8:45 am]
BILLING CODE 4160-01-S
