Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability, 63188-63189 [2010-25850]
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63188
Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued
Number of
respondents
Section and activity
Responses per
respondent
121.9(b) Designated Transplant Program Requirements ............................................................................
121.9(d) Appeal for designation ....................................
10
2
Total ..........................................................................
3,014
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: October 7, 2010.
Wendy Ponton,
Director, Office of Management.
Total
responses
1
1
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Background: The National Healthy
Start Program, funded through the
Health Resources and Services
Administration’s (HRSA) Maternal and
Child Health Bureau (MCHB), was
developed in 1991 with the goal of
reducing infant mortality disparities in
high-risk populations through
community-based interventions. The
program originally began as a five-year
demonstration project within 15
communities that had infant mortality
rates 1.5 to 2.5 times above the national
average.
The National Healthy Start Program
has since expanded in size and mission
to include 102 grantees across the
nation, emphasizing a communitybased, culturally competent approach to
the delivery of care for women and their
Responses
per
respondent
5.0
6
50
12
36,524
..........................
No. of
respondents
Total burden
hours
10
2
Proposed Project Title: Evaluation of
the National Healthy Start Program—
[NEW]
[FR Doc. 2010–25843 Filed 10–13–10; 8:45 am]
Hours per
response
..........................
20,063
babies. MCHB seeks to conduct a crosssite evaluation of all Healthy Start
grantees to document the
accomplishments made by the National
Healthy Start Program.
Purpose: The purpose of the survey is
to collect consistent data on the services
and activities of all 102 Healthy Start
grantees. The data collected though this
survey will be used to:
• Evaluate the grantees’ performance
and progress toward achieving shortterm and long-term goals;
• Evaluate the relationship of
performance and progress to
implementation features of Healthy
Start Program components;
• Assist MCHB in determining on a
national level where technical
assistance may be needed to improve
program performance, set future
priorities for program activities, and
contribute to the overall strategic
planning activities of MCHB; and
• Provide foundation data for future
measurement of the initiative’s longterm impact.
Respondents: The project directors of
Healthy Start grants funded by HRSA
will be the respondents for this data
collection activity. The estimated
response burden is as follows:
Average
hours per
respondent
Total
responses
Total burden
hours
102
1
102
4.0
408
Total ..............................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
Healthy Start Grantee Web Survey .....................................
102
1
102
4.0
408
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: October 7, 2010.
Wendy Ponton,
Director, Office of Management.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–25841 Filed 10–13–10; 8:45 am]
BILLING CODE 4165–15–P
Food and Drug Administration
[Docket No. FDA–2010–D–0500]
Draft Guidance for Industry: Early
Clinical Trials With Live Biotherapeutic
Products: Chemistry, Manufacturing,
and Control Information; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
16:30 Oct 13, 2010
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Notice.
14OCN1
Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Early Clinical
Trials with Live Biotherapeutic
Products: Chemistry, Manufacturing,
and Control Information’’ dated
September 2010. The draft guidance
provides investigational new drug
application (IND) sponsors with
recommendations on the submission of
INDs for early clinical trials with live
biotherapeutic products (LBPs).
DATES: Although you can comment on
any guidance at any time (21 CFR
10.115(g)(5)), to ensure that the agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 13,
2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (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 draft guidance may also be 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 draft guidance
document.
Submit electronic comments on the
draft 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.
FOR FURTHER INFORMATION CONTACT:
Benjamin A. Chacko, 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:
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Early Clinical Trials with Live
Biotherapeutic Products: Chemistry,
Manufacturing, and Control
Information’’ dated September 2010. The
draft guidance provides IND sponsors
with recommendations on the
submission of INDs for early clinical
trials with LBPs.
Regulations in part 312 (21 CFR part
312) require sponsors who wish to study
LBPs in humans to submit an IND to
VerDate Mar<15>2010
16:30 Oct 13, 2010
Jkt 223001
FDA, unless the sponsor falls into one
of the exemptions for clinical
investigations found under § 312.2(b).
The general principles underlying the
IND submission and the general
requirements for an IND’s content and
format are contained in §§ 312.22 and
312.23, respectively. This draft guidance
focuses on the chemistry,
manufacturing, and control information
that should be provided in an IND in
order to meet the requirements under
§ 312.23 for early clinical trials
evaluating LBPs. This draft guidance is
applicable to all INDs of LBPs, whether
clinical trials are conducted
commercially, in an academic setting, or
otherwise (§ 312.2).
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent 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 requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 312 have been approved under
the Office of Management and Budget
(OMB) control number 0910–0014.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
PO 00000
Frm 00049
Fmt 4703
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63189
Dated: October 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25850 Filed 10–13–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0503]
Draft Guidance for Industry on
Investigational New Drug
Applications—Determining Whether
Human Research Studies Can Be
Conducted Without an Investigational
New Drug Application; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Investigational New
Drug Applications (INDs)—Determining
Whether Human Research Studies Can
Be Conducted Without an IND.’’ This
draft guidance is intended to assist
clinical investigators, sponsors, and
sponsor-investigators in determining
whether planned human research
studies must be conducted under an
investigational new drug application
(IND). The guidance describes the basic
criteria for when an IND is required,
describes specific situations in which an
IND is not required, and discusses a
range of issues that, in FDA’s
experience, have been the source of
confusion or misperceptions about the
application of the IND requirements.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 12,
2011. Submit either electronic or
written comments concerning proposed
collection of information by December
13, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation Research (CBER),
Food and Drug Administration, 1401
SUMMARY:
E:\FR\FM\14OCN1.SGM
14OCN1
]]>Agencies
[Federal Register Volume 75, Number 198 (Thursday, October 14, 2010)]
[Notices]
[Pages 63188-63189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25850]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0500]
Draft Guidance for Industry: Early Clinical Trials With Live
Biotherapeutic Products: Chemistry, Manufacturing, and Control
Information; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 63189]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Early Clinical Trials with Live Biotherapeutic Products: Chemistry,
Manufacturing, and Control Information'' dated September 2010. The
draft guidance provides investigational new drug application (IND)
sponsors with recommendations on the submission of INDs for early
clinical trials with live biotherapeutic products (LBPs).
DATES: Although you can comment on any guidance at any time (21 CFR
10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 13, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (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 draft guidance may also be 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 draft
guidance document.
Submit electronic comments on the draft 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.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, 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 draft document entitled
``Guidance for Industry: Early Clinical Trials with Live Biotherapeutic
Products: Chemistry, Manufacturing, and Control Information'' dated
September 2010. The draft guidance provides IND sponsors with
recommendations on the submission of INDs for early clinical trials
with LBPs.
Regulations in part 312 (21 CFR part 312) require sponsors who wish
to study LBPs in humans to submit an IND to FDA, unless the sponsor
falls into one of the exemptions for clinical investigations found
under Sec. 312.2(b). The general principles underlying the IND
submission and the general requirements for an IND's content and format
are contained in Sec. Sec. 312.22 and 312.23, respectively. This draft
guidance focuses on the chemistry, manufacturing, and control
information that should be provided in an IND in order to meet the
requirements under Sec. 312.23 for early clinical trials evaluating
LBPs. This draft guidance is applicable to all INDs of LBPs, whether
clinical trials are conducted commercially, in an academic setting, or
otherwise (Sec. 312.2).
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR part 312 have been approved under the Office of Management and
Budget (OMB) control number 0910-0014.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES) either
electronic or written comments regarding this document. It is only
necessary to send one set of comments. It is no longer necessary to
send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: October 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25850 Filed 10-13-10; 8:45 am]
BILLING CODE 4160-01-P
