Guidance for Industry on Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects; Availability, 55052-55053 [E9-25629]
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Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices
based models, (3) costs of home visiting
programs, and (4) family and child
outcomes (via a review of grantee
analysis reports). A process study will
focus on the broader grant initiative to
understand how programs plan and
develop the infrastructure needed to
support home visitation services and
how they ensure service quality.
Information will be collected through
biennial site visits, web-based data
entry, a data quality progress table, a
relationship questionnaire completed by
participants and home visitors, and a
grantee-partner network survey. In
particular, site visits will include
interviews with key grantee staff and
stakeholders involved in the execution
of the grant and in the efforts to make
system changes. Grantees will complete
systems web-based data entry on goals
and operations every six months while
agencies implementing home visiting
programs associated with the grantee
will utilize the fidelity/cost web-based
data entry to provide EBHV program,
provider, and participant characteristics
along with yearly data on costs of home
visiting programs.
Respondents: EBHV grantee and key
staff (evaluators, home visitors and
supervisors), partners, implementing
agencies, home visiting participants,
and home visitors.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hour
per response
Estimated
annual burden
hours
EBHV grantee and key staff-partner interview guide ......................................
EBHV grantee systems web-based data entry ...............................................
EBHV agency fidelity/cost web-based data entry ...........................................
EBHV grantee data quality progress table ......................................................
Participant-home visitor relationship questionnaire .........................................
Home visitor-participant relationship questionnaire .........................................
EBHV grantee-partner network survey ............................................................
249
17
50
17
4,716
4,716
142
2
2
12
4
2
2
2
1.60
1.00
9.00
4.25
0.25
0.25
0.42
797
34
5,400
289
2,358
2,358
119
Estimated Total Burden Hours .................................................................
........................
........................
........................
11,355
mstockstill on DSKH9S0YB1PROD with NOTICES
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: October 14, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9–25259 Filed 10–23–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0307 (formerly
Docket No. 2007–D–0173)]
Guidance for Industry on Investigator
Responsibilities—Protecting the
Rights, Safety, and Welfare of Study
Subjects; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Investigator Responsibilities—
Protecting the Rights, Safety, and
Welfare of Study Subjects.’’ This
guidance is intended to assist
investigators in meeting their
responsibilities with respect to
protecting human subjects and ensuring
the integrity of data in the conduct of
clinical investigations. The guidance
also clarifies FDA’s expectations
concerning the investigator’s
responsibility for supervising a clinical
study in which some study tasks are
delegated to employees of the
investigator or to outside parties.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
PO 00000
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Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. 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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Joseph Griffin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204,
Silver Spring, MD 20993, 301–796–
2270, Joseph.Griffin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Investigator Responsibilities—
Protecting the Rights, Safety, and
Welfare of Study Subjects.’’ Under the
regulations in part 312 (21 CFR part
312) (Investigational New Drug
Application) and part 812 (21 CFR part
812) (Investigational Device
Exemptions), an investigator is
responsible for ensuring that a clinical
investigation is conducted according to
the signed investigator statement, the
E:\FR\FM\26OCN1.SGM
26OCN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices
investigational plan, and applicable
regulations; for protecting the rights,
safety, and welfare of subjects under the
investigator’s care; and for the control of
drugs, biological products, and devices
under investigation (§§ 312.60 and
812.100). This guidance clarifies the
responsibilities of investigators in the
conduct of clinical investigations
conducted under parts 312 and 812,
particularly the responsibilities to
supervise the conduct of the clinical
investigation, and to protect the rights,
safety, and welfare of study participants
in drug, biologic, and medical device
clinical trials. The guidance also
provides recommendations on how
investigators should supervise the
study-related actions of persons not in
the direct employ of the investigator,
including certain study staff and parties
conducting associated testing and
assessments.
On May 10, 2007 (72 FR 26639), FDA
issued a draft of this guidance with the
goal of received input from the public.
During the finalization of this guidance,
FDA carefully considered all
substantive comments concerning the
content of the guidance. During
finalization, FDA’s major emphasis was
on clarifying issues that were identified
as confusing and correcting apparent
errors. These efforts resulted in
relatively minor changes throughout the
guidance. FDA also removed a
significant amount of content from the
background section because it was
duplicative of content in the guidance
appendices. FDA also reordered section
III.A.3 of the guidance concerning
adequate supervision of the conduct of
a clinical trial to make the sequence
more logical. We reversed the order of
presentation so that the section begins
with the factors that may predispose to
inadequate supervision, and ends with
the steps that could be taken to mitigate
the potential for inadequate supervision.
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 investigator
responsibilities. 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. The 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
VerDate Nov<24>2008
15:19 Oct 23, 2009
Jkt 220001
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 312 have been approved under
OMB control number 0910–0014; and
the collections of information in part
812 have been approved under OMB
control number 0910–0078. The
information requested for general
investigator responsibilities is covered
by the collection of information in
FDA’s regulations for investigational
new drug applications (part 312) and
investigational device exemptions (part
812) and FDA Form 1572. The guidance
also refers to FDA’s requirements in 21
CFR parts 11, 50, 54, and 56 for the
conduct of clinical trials of drugs,
biologics, and medical devices. The
collections of information in 21 CFR
part 11 have been approved under OMB
control number 0910–0303; the
collections of information in 21 CFR
part 54 have been approved under OMB
control number 0910–0396; and the
collections of information in 21 CFR
part 56 (including information required
under 21 CFR part 50) have been
approved under OMB control number
0910–0130. The collection of
information for form FDA 3674 has been
approved under OMB control number
0910–0616.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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 document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25629 Filed 10–23–09; 8:45 am]
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55053
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences; Special Emphasis
Panel Trauma and Burn.
Date: November 19, 2009.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN34, 45 Center
Drive, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Brian R. Pike, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892, 301–594–3907,
pikbr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: October 16, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25513 Filed 10–23–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\26OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55052-55053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25629]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0307 (formerly Docket No. 2007-D-0173)]
Guidance for Industry on Investigator Responsibilities--
Protecting the Rights, Safety, and Welfare of Study Subjects;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Investigator
Responsibilities--Protecting the Rights, Safety, and Welfare of Study
Subjects.'' This guidance is intended to assist investigators in
meeting their responsibilities with respect to protecting human
subjects and ensuring the integrity of data in the conduct of clinical
investigations. The guidance also clarifies FDA's expectations
concerning the investigator's responsibility for supervising a clinical
study in which some study tasks are delegated to employees of the
investigator or to outside parties.
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed
adhesive label to assist that office in processing your requests.
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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Joseph Griffin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993, 301-796-
2270, Joseph.Griffin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Investigator Responsibilities--Protecting the Rights,
Safety, and Welfare of Study Subjects.'' Under the regulations in part
312 (21 CFR part 312) (Investigational New Drug Application) and part
812 (21 CFR part 812) (Investigational Device Exemptions), an
investigator is responsible for ensuring that a clinical investigation
is conducted according to the signed investigator statement, the
[[Page 55053]]
investigational plan, and applicable regulations; for protecting the
rights, safety, and welfare of subjects under the investigator's care;
and for the control of drugs, biological products, and devices under
investigation (Sec. Sec. 312.60 and 812.100). This guidance clarifies
the responsibilities of investigators in the conduct of clinical
investigations conducted under parts 312 and 812, particularly the
responsibilities to supervise the conduct of the clinical
investigation, and to protect the rights, safety, and welfare of study
participants in drug, biologic, and medical device clinical trials. The
guidance also provides recommendations on how investigators should
supervise the study-related actions of persons not in the direct employ
of the investigator, including certain study staff and parties
conducting associated testing and assessments.
On May 10, 2007 (72 FR 26639), FDA issued a draft of this guidance
with the goal of received input from the public. During the
finalization of this guidance, FDA carefully considered all substantive
comments concerning the content of the guidance. During finalization,
FDA's major emphasis was on clarifying issues that were identified as
confusing and correcting apparent errors. These efforts resulted in
relatively minor changes throughout the guidance. FDA also removed a
significant amount of content from the background section because it
was duplicative of content in the guidance appendices. FDA also
reordered section III.A.3 of the guidance concerning adequate
supervision of the conduct of a clinical trial to make the sequence
more logical. We reversed the order of presentation so that the section
begins with the factors that may predispose to inadequate supervision,
and ends with the steps that could be taken to mitigate the potential
for inadequate supervision.
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 investigator responsibilities. 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. The 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 part 312 have been approved under OMB
control number 0910-0014; and the collections of information in part
812 have been approved under OMB control number 0910-0078. The
information requested for general investigator responsibilities is
covered by the collection of information in FDA's regulations for
investigational new drug applications (part 312) and investigational
device exemptions (part 812) and FDA Form 1572. The guidance also
refers to FDA's requirements in 21 CFR parts 11, 50, 54, and 56 for the
conduct of clinical trials of drugs, biologics, and medical devices.
The collections of information in 21 CFR part 11 have been approved
under OMB control number 0910-0303; the collections of information in
21 CFR part 54 have been approved under OMB control number 0910-0396;
and the collections of information in 21 CFR part 56 (including
information required under 21 CFR part 50) have been approved under OMB
control number 0910-0130. The collection of information for form FDA
3674 has been approved under OMB control number 0910-0616.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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 document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25629 Filed 10-23-09; 8:45 am]
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