Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards, 57948-57949 [E7-20063]
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Federal Register / Vol. 72, No. 196 / Thursday, October 11, 2007 / Notices
Street, SW., Suite 9100, Washington, DC
20201.
Status: Open to the public, limited
only by the space available.
Purpose: The Committee is charged
with providing advice and guidance to
the Secretary, the Assistant Secretary for
Health, the Director, CDC, and the
Director, National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID),
regarding (1) The practice of hospital
infection control; (2) strategies for
surveillance, prevention, and control of
infections (e.g., nosocomial infections),
antimicrobial resistance, and related
events in settings where healthcare is
provided; and (3) periodic updating of
guidelines and other policy statements
regarding prevention of healthcareassociated infections and healthcarerelated conditions.
Matters To Be Discussed: Agenda
items will include: IT Standards
Update; White Paper Updates; and
Updates on the Disinfection and
Sterilization Guideline. Agenda items
are subject to change as priorities
dictate.
Contact Person for More Information:
Angela B. Scott, Committee
Management Specialist, HICPAC,
Division of Healthcare Quality
Promotion, NCPDCID, CDC, 1600
Clifton Road, NE., Mailstop A–45,
Atlanta, Georgia 30333. Telephone:
(404) 639–1526.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: October 4, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. E7–20045 Filed 10–10–07; 8:45 am]
BILLING CODE 4163–18–P
Institutional Review Boards—21 CFR
56.115 (OMB Control Number 0910–
0130)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0241]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Institutional
Review Boards
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.
Fax written comments on the
collection of information by November
13, 2007.
DATES:
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0130.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4816.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
When reviewing clinical research
studies regulated by FDA, institutional
review boards (IRBs) are required to
create and maintain records describing
their operations, and make the records
available for FDA inspection when
requested. These records include:
Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; the research
protocols, informed consent documents,
progress reports, and reports of injuries
to subjects submitted by investigators to
the IRB; minutes of meetings showing
attendance, votes, and decisions made
by the IRB, the number of votes on each
decision for, against, and abstaining, the
basis for requiring changes in or
disapproving research; records of
continuing review activities; copies of
all correspondence between
investigators and the IRB; statement of
significant new findings provided to
subjects of the research; and a list of IRB
members by name, showing each
member’s earned degrees, representative
capacity, and experience in sufficient
detail to describe each member’s
contributions to the IRB’s deliberations,
and any employment relationship
between each member and the IRB’s
institution. This information is used by
FDA in conducting audit inspections of
IRBs to determine whether IRBs and
clinical investigators are providing
adequate protections to human subjects
participating in clinical research.
In the Federal Register of June 28,
2007 (72 FR 35492), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
No. of
Recordkeepers
56.115
Annual Frequency
per Recordkeeping
5,000
14.6
Total Annual
Records
Hours per
Record
73,000
100
Total
rwilkins on PROD1PC63 with NOTICES
1There
Total Hours
7,300,000
7,300,000
are no capital costs or operating and maintenance costs associated with this collection of information.
The recordkeeping requirement
burden is based on the following: The
burden for each of the paragraphs under
21 CFR 56.115 has been considered as
one estimated burden. FDA estimates
VerDate Aug<31>2005
16:09 Oct 10, 2007
Jkt 214001
that there are approximately 5,000 IRBs.
The IRBs meet an average of 14.6 times
annually. The agency estimates that
approximately 100 hours of person-time
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
per meeting are required to meet the
requirements of the regulation.
E:\FR\FM\11OCN1.SGM
11OCN1
Federal Register / Vol. 72, No. 196 / Thursday, October 11, 2007 / Notices
Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20063 Filed 10–10–07; 8:45 am]
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
BILLING CODE 4160–01–S
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Generic Food and Drug Administration
Rapid Response Surveys—(OMB
Control Number 0910–0500)—Extension
[Docket No. 2007N–0092]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Food and
Drug Administration Rapid Response
Surveys
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 November
13, 2007.
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0500. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355), requires that important safety
information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the act. Under section
519 of the act (21 U.S.C. 360i), FDA is
authorized to require manufacturers to
report medical device-related deaths,
serious injuries, and malfunctions to
FDA; to require user facilities to report
device-related deaths directly to FDA
and to manufacturers; and to report
serious injuries to the manufacturer.
Section 522 of the act (21 U.S.C. 360l)
authorizes FDA to require
manufacturers to conduct postmarket
surveillance of medical devices. Section
705(b) of the act (21 U.S.C. 375(b))
authorizes FDA to collect and
disseminate information regarding
medical products or cosmetics in
situations involving imminent danger to
health or gross deception of the
consumer. Section 903(d)(2) of the act
(21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA. These
57949
sections of the act enable FDA to
enhance consumer protection from risks
associated with medical products usage
that are not foreseen or apparent during
the premarket notification and review
process. FDA’s regulations governing
application for agency approval to
market a new drug (21 CFR part 314)
and regulations governing biological
products (21 CFR part 600) implement
these statutory provisions. Currently
FDA monitors medical product related
postmarket adverse events via both the
mandatory and voluntary MedWatch
reporting systems using FDA Forms
3500 and 3500A (OMB control number
0910–0291) and the vaccine adverse
event reporting system. FDA is seeking
OMB clearance to collect vital
information via a series of rapid
response surveys. Participation in these
surveys will be voluntary. This request
covers rapid response surveys for
community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to obtain
quickly vital information about medical
product risks and interventions to
reduce risks so the agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
In the Federal Register of March 22,
2007 (72 FR 13498), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
Respondents
Annual Frequency
per Response
200
rwilkins on PROD1PC63 with NOTICES
1 There
Total Annual
Responses
30
Hours per
Response
6000
Total Hours
.5
3000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA projects 30 emergency risk
related surveys per year with a sample
of between 50 and 200 respondents per
survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
can analyze in a timely manner. The
annual frequency of response was
determined by the maximum number of
VerDate Aug<31>2005
16:09 Oct 10, 2007
Jkt 214001
questionnaires that will be sent to any
individual respondent. Some
respondents may be contacted only one
time per year, while other respondents
may be contacted several times
annually, depending on the human
drug, biologic, or medical device under
evaluation. It is estimated that, given the
expected type of issues that will be
addressed by the surveys, it will take 0.5
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
hours for a respondent to gather the
requested information and fill in the
answers.
Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20067 Filed 10–10–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Pages 57948-57949]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20063]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0241]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Institutional Review
Boards
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
November 13, 2007.
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 baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0130.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4816.
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.
Institutional Review Boards--21 CFR 56.115 (OMB Control Number 0910-
0130)--Extension
When reviewing clinical research studies regulated by FDA,
institutional review boards (IRBs) are required to create and maintain
records describing their operations, and make the records available for
FDA inspection when requested. These records include: Written
procedures describing the structure and membership of the IRB and the
methods that the IRB will use in performing its functions; the research
protocols, informed consent documents, progress reports, and reports of
injuries to subjects submitted by investigators to the IRB; minutes of
meetings showing attendance, votes, and decisions made by the IRB, the
number of votes on each decision for, against, and abstaining, the
basis for requiring changes in or disapproving research; records of
continuing review activities; copies of all correspondence between
investigators and the IRB; statement of significant new findings
provided to subjects of the research; and a list of IRB members by
name, showing each member's earned degrees, representative capacity,
and experience in sufficient detail to describe each member's
contributions to the IRB's deliberations, and any employment
relationship between each member and the IRB's institution. This
information is used by FDA in conducting audit inspections of IRBs to
determine whether IRBs and clinical investigators are providing
adequate protections to human subjects participating in clinical
research.
In the Federal Register of June 28, 2007 (72 FR 35492), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115 5,000 14.6 73,000 100 7,300,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 7,300,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The recordkeeping requirement burden is based on the following: The
burden for each of the paragraphs under 21 CFR 56.115 has been
considered as one estimated burden. FDA estimates that there are
approximately 5,000 IRBs. The IRBs meet an average of 14.6 times
annually. The agency estimates that approximately 100 hours of person-
time per meeting are required to meet the requirements of the
regulation.
[[Page 57949]]
Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20063 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S
