Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs, 63325-63327 [E6-18067]
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Federal Register / Vol. 71, No. 209 / Monday, October 30, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
ORR–3 .............................................................................................................
ORR–4 .............................................................................................................
Number of
responses per
respondent
Average burden hours per
response
15
60
.417
.250
15
15
Total burden
hours
94
225
Estimated total annual burden hours: 319.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503. Attn: Desk
Officer for ACF. E-mail address:
Karen_Y._Matsuoka@omb.eop.gov.
Dated: October 26, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–8958 Filed 10–27–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission of OMB Review; Comment
Request
Title: Compassion Capital Fund
Evaluation—Intermediary Survey.
OMB No.: New Collection.
Description: This proposed
information collection activity is for a
survey to be completed by Compassion
Capital Fund intermediary grantees as a
part of the outcome and impact study
components of the Compassion Capital
Fund Evaluation.
The Compassion Capital F und
Evaluation is a multi-component study
designed to examine the effectiveness of
the Compassion Capital Fund (CCF) in
meeting its objective of improving the
organizational capacity of faith-based
and community organizations. The CCF
program works through intermediary
organizations to provide capacity
building assistance to interested faithbased and community organizations.
The purpose of this data collection
activity is to obtain more detailed
information about the management
processes and service delivery and
monitoring approaches used by CCF
intermediaries in providing technical
and financial assistance to increase the
organizational capacity of faith-based
and community organizations.
Respondents: CCF intermediary
grantees.
Annual Burden Estimates
Number of
respondents
Number of
responses per
respondent
Average burden hours per
response
Total burden
hours
Intermediary survey .........................................................................................
sroberts on PROD1PC70 with NOTICES
Instrument
54
1
.5
27
Estimated Total Annual Burden
Hours: 27.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L/Enfant Promenade, SW.,
Washington, DC 20447, ATtn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sen directly to the following: Office
of Management and Budget, Paperwork
VerDate Aug<31>2005
02:16 Oct 28, 2006
Jkt 211001
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Karen_Y._Matsuoka@omb.eop.gov.
Dated: October 5, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–8959 Filed 10–27–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0420]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Orphan Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Fmt 4703
Submit written or electronic
comments on the collection of
information by December 29, 2006.
DATES:
Submit electronic
comments on the collection of
ADDRESSES:
Notice.
Frm 00047
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
the procedures by which sponsors of
orphan drugs may request eligibility for
the incentives by implementing a
program as outlined in the Orphan Drug
Act.
Sfmt 4703
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63326
Federal Register / Vol. 71, No. 209 / Monday, October 30, 2006 / Notices
information to: https://www.fda.gov/
dockets/ecomments. 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–827–
4659.
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
SUPPLEMENTARY INFORMATION:
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.
Orphan Drugs—21 CFR 316 (OMB
Control Number 0910–0167)—Extension
Sections 525 through 526 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360aa through 360
dd) give FDA statutory authority to do
the following: (1) Provide
recommendations on investigations
required for approval of marketing
applications for orphan drugs, (2)
designate eligible drugs as orphan
drugs, (3) set forth conditions under
which a sponsor of an approved orphan
drug obtains exclusive approval, and (4)
encourage sponsors to make orphan
drugs available for treatment on an
‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the act and sets forth procedures FDA
will use in administering the act with
regard to orphan drugs. Section 316.10
specifies the content and format of a
request for written recommendations
concerning the non-clinical laboratory
studies and clinical investigations
necessary for approval of marketing
applications. Section 316.12 provides
that, before providing such
recommendations, FDA may require
results of studies to be submitted for
review. Section 316.14 contains
provisions permitting FDA to refuse to
provide written recommendations under
certain circumstances. Within 90 days
of any refusal, a sponsor may submit
additional information specified by
FDA. Section 316.20 specifies the
content and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
expectation of recovering costs of
research and development of the drug.
Section 316.26 allows an applicant to
amend the applications under certain
circumstances. Section 316.30 requires
submission of annual reports, including
progress reports on studies, a
description of the investigational plan,
and a discussion of changes that may
affect orphan status. The information
requested will provide the basis for an
FDA determination that the drug is for
a rare disease or condition and satisfies
the requirements for obtaining orphan
drug status. Secondly, the information
will describe the medical and regulatory
history of the drug. The respondents to
this collection of information are
biotechnology firms, drug companies,
and academic clinical researchers.
The information requested from
respondents represents, for the most
part, an accounting of information
already in the possession of the
applicant. It is estimated, based on
frequency of requests over the past 5
years, that 171 persons or organizations
per year will request orphan-drug
designation and none will request
formal recommendations on design of
preclinical or clinical studies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Responses
Total Hours
5
1
5
130
650
316.20, 316.21, & 316.26
171
2.0
342
130
44,460
316.22
30
1
30
2
60
316.27
25
1
25
4
100
316.30
sroberts on PROD1PC70 with NOTICES
316.10, 316.12, & 316.14
500
1
500
2
1,000
316.36
.2
3
.6
15
9
Total
1 There
46,279
are no capital costs or maintenance costs associated with this collection of information.
VerDate Aug<31>2005
02:16 Oct 28, 2006
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Federal Register / Vol. 71, No. 209 / Monday, October 30, 2006 / Notices
Dated: October 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18067 Filed 10–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0198]
Guidance for Industry on
Implementation of Acceptable FullLength Donor History Questionnaire
and Accompanying Materials for Use
in Screening Donors of Blood and
Blood Components; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Implementation
of Acceptable Full-Length Donor
History Questionnaire and
Accompanying Materials for Use in
Screening Donors of Blood and Blood
Components,’’ dated October 2006. The
guidance document provides blood
establishments that collect blood and
blood components intended for
transfusion or for further manufacture
with advice on reporting to FDA a
manufacturing change consisting of the
implementation of a standardized fulllength donor history questionnaire and
accompanying materials (DHQ
documents). The guidance document
addresses which DHQ documents are
acceptable, and establishes the process
for FDA to recognize other DHQ
documents in the future. The guidance
announced in this notice finalizes the
draft guidance entitled ‘‘Guidance for
Industry: Acceptable Full-Length Donor
History Questionnaire and
Accompanying Materials for Use in
Screening Human Donors of Blood and
Blood Components’’ dated April 2004.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
sroberts on PROD1PC70 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
02:16 Oct 28, 2006
Jkt 211001
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Implementation of Acceptable
Full-Length Donor History
Questionnaire and Accompanying
Materials for Use in Screening Donors of
Blood and Blood Components,’’ dated
October 2006. The guidance document
provides blood establishments that
collect blood and blood components
intended for transfusion or for further
manufacture with advice on reporting to
FDA a manufacturing change consisting
of the implementation of DHQ
documents. Acceptable DHQ documents
(DHQ documents that provide licensed
and unlicensed manufacturers with one
means of complying with the FDA
requirements for collecting donor
history information) will provide
manufacturers with a specific process
for administering questions to donors of
blood and blood components to
determine their eligibility to donate.
The guidance document advises
licensed manufacturers who choose to
implement acceptable DHQ documents
on how to report the manufacturing
change to FDA, and recognizes the
Donor History Questionnaire Version
No. 1.1 dated June 2005 (v.DHQ–1.1),
prepared by the AABB (formerly known
as the American Association of Blood
Banks) Donor History Task Force, as
acceptable DHQ documents.
In the future, FDA may recognize
other DHQ documents as acceptable,
and intends to make all of the
acceptable DHQ documents available on
FDA’s Web site. FDA believes that
acceptable DHQ documents will assist
manufacturers in complying with the
regulations under 21 CFR 640.3 and
640.63. The guidance also advises
licensed manufacturers of blood and
blood components who choose to
implement acceptable DHQ documents
PO 00000
Frm 00049
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Sfmt 4703
63327
on how to report the manufacturing
change to FDA under 21 CFR 601.12.
In the Federal Register of May 12,
2004 (69 FR 26399), FDA announced the
availability of the draft guidance
entitled ‘‘Guidance for Industry:
Acceptable Full-Length Donor History
Questionnaire and Accompanying
Materials for Use in Screening Human
Donors of Blood and Blood
Components’’ dated April 2004. This
draft guidance contained the full-length
donor history questionnaire and
accompanying materials (Version No. 1,
dated April 2004) (v.DHQ–1). FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. A summary of changes to the
guidance includes the following: (1)
Added a statement to direct inquiries
regarding the v.DHQ–1.1 or other AABB
DHQ documents to the task force; (2)
clarified how to implement acceptable
DHQ documents, including v.DHQ–1.1,
and the self-administration of these
documents; and (3) added a separate
Web site link to access all DHQ
documents that FDA has recognized as
acceptable. In addition, FDA received
many comments on the v.DHQ–1, and
forwarded these comments to the task
force. In response, the task force
submitted updated DHQ documents
(v.DHQ–1.1), for FDA’s review. The
guidance announced in this notice
finalizes the draft guidance dated April
2004, and refers to the v.DHQ–1.1.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. 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 statutes
and regulations.
II. 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 606.160 have been approved
under OMB control numbers 0910–
0116; those in 21 CFR 601.12 have been
approved under 0910–0338.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
E:\FR\FM\30OCN1.SGM
30OCN1
]]>Agencies
[Federal Register Volume 71, Number 209 (Monday, October 30, 2006)]
[Notices]
[Pages 63325-63327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0420]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs
AGENCY: Food and Drug Administration, HHS.
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 the procedures by which
sponsors of orphan drugs may request eligibility for the incentives by
implementing a program as outlined in the Orphan Drug Act.
DATES: Submit written or electronic comments on the collection of
information by December 29, 2006.
ADDRESSES: Submit electronic comments on the collection of
[[Page 63326]]
information to: https://www.fda.gov/dockets/ecomments. 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 the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,301-827-4659.
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 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.
Orphan Drugs--21 CFR 316 (OMB Control Number 0910-0167)--Extension
Sections 525 through 526 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360aa through 360 dd) give FDA statutory
authority to do the following: (1) Provide recommendations on
investigations required for approval of marketing applications for
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set
forth conditions under which a sponsor of an approved orphan drug
obtains exclusive approval, and (4) encourage sponsors to make orphan
drugs available for treatment on an ``open protocol'' basis before the
drug has been approved for general marketing. The implementing
regulations for these statutory requirements have been codified under
part 316 (21 CFR part 316) and specify procedures that sponsors of
orphan drugs use in availing themselves of the incentives provided for
orphan drugs in the act and sets forth procedures FDA will use in
administering the act with regard to orphan drugs. Section 316.10
specifies the content and format of a request for written
recommendations concerning the non-clinical laboratory studies and
clinical investigations necessary for approval of marketing
applications. Section 316.12 provides that, before providing such
recommendations, FDA may require results of studies to be submitted for
review. Section 316.14 contains provisions permitting FDA to refuse to
provide written recommendations under certain circumstances. Within 90
days of any refusal, a sponsor may submit additional information
specified by FDA. Section 316.20 specifies the content and format of an
orphan drug application which includes requirements that an applicant
document that the disease is rare (affects fewer than 200,000 persons
in the United States annually) or that the sponsor of the drug has no
reasonable expectation of recovering costs of research and development
of the drug. Section 316.26 allows an applicant to amend the
applications under certain circumstances. Section 316.30 requires
submission of annual reports, including progress reports on studies, a
description of the investigational plan, and a discussion of changes
that may affect orphan status. The information requested will provide
the basis for an FDA determination that the drug is for a rare disease
or condition and satisfies the requirements for obtaining orphan drug
status. Secondly, the information will describe the medical and
regulatory history of the drug. The respondents to this collection of
information are biotechnology firms, drug companies, and academic
clinical researchers.
The information requested from respondents represents, for the most
part, an accounting of information already in the possession of the
applicant. It is estimated, based on frequency of requests over the
past 5 years, that 171 persons or organizations per year will request
orphan-drug designation and none will request formal recommendations on
design of preclinical or clinical studies.
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
21 CFR Section Respondents per Response Responses Responses Total Hours
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, & 5 1 5 130 650
316.14
----------------------------------------------------------------------------------------------------------------
316.20, 316.21, & 171 2.0 342 130 44,460
316.26
----------------------------------------------------------------------------------------------------------------
316.22 30 1 30 2 60
----------------------------------------------------------------------------------------------------------------
316.27 25 1 25 4 100
----------------------------------------------------------------------------------------------------------------
316.30 500 1 500 2 1,000
----------------------------------------------------------------------------------------------------------------
316.36 .2 3 .6 15 9
----------------------------------------------------------------------------------------------------------------
Total .............. ................. ................. ................. 46,279
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this collection of information.
[[Page 63327]]
Dated: October 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18067 Filed 10-27-06; 8:45 am]
BILLING CODE 4160-01-S
