Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure, 60848-60851 [E7-21126]
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Dated: October 11, 2007.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Protection of Human Subjects:
Categories of Research That May Be
Reviewed by the Institutional Review
Board Through an Expedited Review
Procedure
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
AGENCY:
SUMMARY: The Office for Human
Research Protections (OHRP) is
requesting written comments on a
proposed amendment to item 5 of the
categories of research that may be
reviewed by the institutional review
board (IRB) through an expedited
review procedure, last published in the
Federal Register on November 9, 1998
(63 FR 60364). On that date, the Office
for Protection from Research Risks
(OPRR), now OHRP, and the Food and
Drug Administration (FDA)
simultaneously published identical lists
of categories of research activities
involving human subjects which may be
reviewed by the IRB through an
expedited review procedure. It has come
to OHRP’s attention that there has been
confusion in the research community
about expedited review category 5.
OHRP is proposing to amend expedited
review category 5 to clarify that the
category includes research involving
materials that were previously collected
for either nonresearch or research
purposes, provided that any materials
collected for research were not collected
for the currently proposed research.
Expedited review category 5 also
includes research involving materials
that will be collected solely for
nonresearch purposes.
In addition, OHRP is requesting
comments on the entire expedited
review list that was last published in the
Federal Register on November 9, 1998
(63 FR 60364) to determine if other
changes are needed.
As part of its charge to provide expert
advice and recommendations to the
Secretary of Health and Human Services
(the Secretary) and the Assistant
Secretary for Health on issues and
topics pertaining to or associated with
the protection of human research
subjects, the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP), through its
Subcommittee on Subpart A, considered
whether the current expedited review
categories should be modified. On
March 14, 2007, SACHRP submitted
recommendations regarding expedited
review to the Secretary, and on June 18,
2007, the Secretary sent a letter to the
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SACHRP chairperson, stating that HHS
would give serious consideration to
these recommendations. In regard to the
current expedited review categories,
SACHRP recommended that expedited
review category 7 should be revised as
described in Section V below.
Therefore, in addition to requesting
comments on the entire expedited
review list that was published in the
Federal Register on November 9, 1998
(63 FR 60364), OHRP is also specifically
requesting comments on SACHRP’s
recommended revision of expedited
review category 7.
As required under 21 CFR 56.110(a),
FDA also will publish in the Federal
Register a list of categories of research
that may be reviewed by the IRB
through an expedited review procedure.
FDA intends to issue the list
concurrently with OHRP’s issuance of
its final notice, and in compliance with
21 CFR 10.115 (good guidance practice
regulations). This approach maintains
FDA’s practice of moving in tandem on
this issue with OHRP.
DATES: Submit written or electronic
comments by December 26, 2007.
ADDRESSES: Submit written comments
to EXPEDITED REVIEW, Office for
Human Research Protections, The
Tower Building, 1101 Wootton
Parkway, Suite 200, Rockville, MD
20852. Comments also may be sent via
e-mail to expeditedreviewohrp@hhs.gov,
or via facsimile at 301–402–2071.
Comments received within the comment
period, including any personal
information provided, will be made
available to the public upon request.
FOR FURTHER INFORMATION CONTACT: Mr.
Glen Drew, Office for Human Research
Protections, The Tower Building, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852, 1–866–447–4777 or by email to: glen.drew@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Expedited Review Procedures
The Department of Health and Human
Services (HHS) human subjects
protection regulations at 45 CFR 46.110
permit expedited review procedures for
certain kinds of human subjects
research that have been found by an IRB
to involve no more than minimal risk to
research subjects, or for minor changes
in previously IRB-approved research
during the period (of one year or less)
for which approval is authorized. An
expedited review procedure consists of
a review of research involving human
subjects by the IRB chairperson or by
one or more experienced reviewers
designated by the chairperson from
among members of the IRB, in
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accordance with the requirements at 45
CFR 46.110.
The HHS regulations at 45 CFR 46.110
also give the Secretary the authority to
amend and republish the list of research
categories that may be reviewed by the
IRB through an expedited review
procedure, after consultation with other
departments and agencies. This same
section of the HHS regulations also
requires that an amended expedited
review list be published by the
Secretary in the Federal Register.
As required by HHS regulations at 45
CFR 46.110, this proposed amendment
of expedited review category 5 was
developed after consulting with the
other Federal departments and agencies
that have promulgated the Federal
Policy for the Protection of Human
Subjects.
II. Background on the Expedited
Review List
The first expedited review list was
published by the Secretary in 1981 (46
FR 8392). On November 10, 1997,
OPRR, now OHRP, and FDA published
identical proposed revisions to the 1981
expedited review list (published for
OPRR at 62 FR 60607). The category of
research in question, expedited review
category 5, was addressed in the
proposed categories 4 and 5 in the
November 10, 1997 Federal Register
Notices requesting public comment. In
those Notices, proposed categories 4 and
5 were presented as follows:
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(4) Research involving existing identifiable
data, documents, records, or biological
specimens (including pathological or
diagnostic specimens) where these materials,
in their entirety, have been collected prior to
the research, for a purpose other than the
proposed research.
(5) Research involving solely (a)
prospectively collected identifiable residual
or discarded specimens, or (b) prospectively
collected identifiable data, documents, or
records, where (a) or (b) has been generated
for nonresearch purposes.
In addition, a chart included in
OPRR’s and FDA’s November 10, 1997
Federal Register Notices, comparing the
proposed expedited review list with the
1981 list, indicated that the proposed
category 4 (see above) was intended to
replace expedited review category 8 on
the 1981 list. Category 8 on the 1981 list
stated, ‘‘the study of existing data,
documents, records, pathological
specimens, or diagnostic specimens.’’
The comments received on OPRR’s
and FDA’s November 10, 1997 Federal
Register Notices overwhelmingly
supported the proposed revision to the
expedited review list. With minor
modifications to the 1997 proposed
expedited review list, on November 9,
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1998, OPRR and FDA simultaneously
published identical revised lists of
categories of research activities that may
be reviewed by the IRB through the
expedited review procedure (published
for OPRR at 63 FR 60364, and for FDA
at 63 FR 60353). In regard to expedited
review category 5, the OPRR and FDA
November 9, 1998 Federal Register
Notices described this category of
research as:
(5) Research involving materials (data,
documents, records, or specimens) that have
been collected or will be collected solely for
nonresearch purposes (such as medical
treatment or diagnosis). (Note: Some research
in this category may be exempt from the HHS
regulations for the protection of human
subjects. 45 CFR 46.101(b)(4). This listing
refers only to research that is not exempt.)
The preamble of the OPRR November
9, 1998 Federal Register Notice
explained that:
Categories four (4) and five (5) on the
proposed list have been combined into one
new category five (5) on the 1998 list. This
new section is added in response to
comments that raised questions about the
relationship of proposed categories four (4)
and five (5) to exempt research and about
separating out existing and prospectively
collected materials. The term ‘‘nonresearch
purposes’’ was maintained in new category
five (5) to describe the origins of the research
material * * *
Similarly, the FDA November 9, 1998
Federal Register Notice explained that:
Categories four and five on the proposed
list have been combined into one new
category, category five, addressing research
involving materials collected or which will
be collected solely for nonresearch purposes.
This new category five was formed in
response to comments that raised questions
about why the two categories separated out
existing and prospectively collected
materials. The term ‘‘nonresearch purposes’’
was maintained in new category five to
describe the origins of the research materials.
III. Clarification on the Scope of
Expedited Review Category Five (5)
Needed
The description of expedited review
category 5 and the preamble language as
published in the November 9, 1998
OPRR and FDA Federal Register
Notices has caused confusion in the
research community about whether this
expedited review category includes
research involving materials that were
originally collected for either
nonresearch or research purposes, or is
limited to research involving materials
that were originally collected solely for
nonresearch purposes.
As evidence of this confusion, in their
1999 report, Research Involving Human
Biological Materials: Ethical Issues and
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60849
Policy Guidance, the National Bioethics
Advisory Commission (NBAC) stated:
NBAC finds that there is no need to
distinguish between collections originally
created for clinical purposes and those
created for research purposes. In both cases,
research on the collected materials should be
eligible for expedited review if the research
presents no more than a minimal risk to the
study subjects.
As a result of this finding, NBAC
recommended that ‘‘OPRR should revise
its guidance to make clear that all
minimal-risk research involving human
biological materials—regardless of how
they were collected—should be eligible
for expedited IRB review.’’ In response
to NBAC’s 1999 report, HHS convened
a multi-agency Working Group to
analyze the appropriateness, feasibility,
and practical implications of
implementing NBAC’s
recommendations and to develop a set
of proposed HHS activities to enhance
the protection of human subjects in
research involving human biological
materials. In regard to the NBAC
recommendation above, the HHS
Working Group stated:
The Working Group concurs with
Recommendation 2 and agrees with NBAC
that, for purposes of determining eligibility
for expedited IRB review, it is not necessary
to draw a distinction between samples
originally collected for clinical purposes and
those obtained for research purposes. The
Working Group also agrees with NBAC’s
observation that current guidance regarding
the types of research that IRBs may review
through expedited procedures (63 FR 60364
[HHS] and 60353 [FDA], November 9, 1998)
appears to exclude research utilizing existing
specimens previously collected for research
purposes. It is the understanding of the
Working Group that this apparent exclusion
is not intentional but rather resulted from a
copy editing oversight * * *
IV. OHRP Assessment
After reviewing OPRR’s and FDA’s
1997 and 1998 Federal Register notices
concerning revisions to the 1981
expedited review list, NBAC’s
recommendation, and the HHS Working
Group’s response, OHRP has concluded
that expedited review category 5 was
intended to, and should, include
research involving existing information
or specimens that were previously
collected for nonresearch purposes, as
well as research involving existing
information or specimens that were
previously collected for research
purposes—provided they were not
collected for the currently proposed
research.
OHRP notes that neither OPRR’s nor
FDA’s November 10, 1997 Federal
Register Notice indicated that the
proposed expedited review category 4
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was intended to narrow category 8 on
the 1981 list to exclude existing
specimens that were collected for
research purposes, provided the
materials were collected for a research
purpose other than the proposed
research. Because proposed category 4
would have applied to research
involving existing identifiable
information or specimens that had been
previously collected for either research
or nonresearch purposes, provided they
were not collected for the currently
proposed research, OHRP has
concluded that the term ‘‘nonresearch
purposes’’ was retained in the final
version of category 5 to describe the
origins of the prospectively collected
material only, not the origins of the
previously collected material. However,
this intent was not made clear in either
OPRR’s or FDA’s November 9, 1998
Federal Register Notice.
V. OHRP Request for Comments
For the reasons described in Section
IV, OHRP is proposing to revise
expedited review category 5 as set forth
below.
Remove (5) in its entirety, and add, in
its place:
(5) Research involving materials (data,
documents, records, or specimens) that
(a) have previously been collected for
nonresearch purposes;
(b) have previously been collected for
research purposes, provided the
materials were not collected for the
currently proposed research; or
(c) will be collected solely for
nonresearch purposes.
Note: Some research under section (a) or
(b) of this category may be exempt from the
HHS regulations for the protection of human
subjects. 45 CFR 46.101(b)(4). This listing
refers only to research that is not exempt.
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OHRP is also requesting comments on
the entire expedited review list that was
last published in the Federal Register
on November 9, 1998 (63 FR 60364) to
determine if other changes are needed.
The following is the current expedited
review list, as published in the Federal
Register on November 9, 1998:
(1) Clinical studies of drugs and medical
devices only when condition (a) or (b) is met.
(a) Research on drugs for which an
investigational new drug application (21 CFR
Part 312) is not required. (Note: Research on
marketed drugs that significantly increases
the risks or decreases the acceptability of the
risks associated with the use of the product
is not eligible for expedited review.)
(b) Research on medical devices for which
(i) an investigational device exemption
application (21 CFR Part 812) is not required;
or (ii) the medical device is cleared/approved
for marketing and the medical device is being
used in accordance with its cleared/approved
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(2) Collection of blood samples by finger
stick, heel stick, ear stick, or venipuncture as
follows:
(a) from healthy, nonpregnant adults who
weigh at least 110 pounds. For these subjects,
the amounts drawn may not exceed 550 ml
in an 8 week period and collection may not
occur more frequently than 2 times per week;
or
(b) from other adults and children,2
considering the age, weight, and health of the
subjects, the collection procedure, the
amount of blood to be collected, and the
frequency with which it will be collected.
For these subjects, the amount drawn may
not exceed the lesser of 50 ml or 3 ml per
kg in an 8 week period and collection may
not occur more frequently than 2 times per
week.
(3) Prospective collection of biological
specimens for research purposes by
noninvasive means.
Examples: (a) Hair and nail clippings in a
nondisfiguring manner; (b) deciduous teeth
at time of exfoliation or if routine patient care
indicates a need for extraction; (c) permanent
teeth if routine patient care indicates a need
for extraction; (d) excreta and external
secretions (including sweat); (e)
uncannulated saliva collected either in an
unstimulated fashion or stimulated by
chewing gumbase or wax or by applying a
dilute citric solution to the tongue; (f)
placenta removed at delivery; (g) amniotic
fluid obtained at the time of rupture of the
membrane prior to or during labor; (h) supraand subgingival dental plaque and calculus,
provided the collection procedure is not
more invasive than routine prophylactic
scaling of the teeth and the process is
accomplished in accordance with accepted
prophylactic techniques; (i) mucosal and skin
cells collected by buccal scraping or swab,
skin swab, or mouth washings; (j) sputum
collected after saline mist nebulization.
(4) Collection of data through noninvasive
procedures (not involving general anesthesia
or sedation) routinely employed in clinical
practice, excluding procedures involving xrays or microwaves. Where medical devices
are employed, they must be cleared/approved
for marketing. (Studies intended to evaluate
the safety and effectiveness of the medical
device are not generally eligible for expedited
review, including studies of cleared medical
devices for new indications.)
Examples: (a) Physical sensors that are
applied either to the surface of the body or
at a distance and do not involve input of
significant amounts of energy into the subject
or an invasion of the subject’s privacy; (b)
weighing or testing sensory acuity; (c)
magnetic resonance imaging; (d)
electrocardiography, electroencephalography,
thermography, detection of naturally
occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography;
(e) moderate exercise, muscular strength
testing, body composition assessment, and
flexibility testing where appropriate given
the age, weight, and health of the individual.
(5) Research involving materials (data,
documents, records, or specimens) that have
been collected, or will be collected solely for
nonresearch purposes (such as medical
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treatment or diagnosis). (Note: Some research
in this category may be exempt from the HHS
regulations for the protection of human
subjects. 45 CFR 46.101(b)(4). This listing
refers only to research that is not exempt.)
(6) Collection of data from voice, video,
digital, or image recordings made for research
purposes.
(7) Research on individual or group
characteristics or behavior (including, but not
limited to, research on perception, cognition,
motivation, identity, language,
communication, cultural beliefs or practices,
and social behavior) or research employing
survey, interview, oral history, focus group,
program evaluation, human factors
evaluation, or quality assurance
methodologies. (Note: Some research in this
category may be exempt from the HHS
regulations for the protection of human
subjects. 45 CFR 46.101(b)(2) and (b)(3). This
listing refers only to research that is not
exempt.)
(8) Continuing review of research
previously approved by the convened IRB as
follows:
(a) Where (i) the research is permanently
closed to the enrollment of new subjects; (ii)
all subjects have completed all researchrelated interventions; and (iii) the research
remains active only for long-term follow-up
of subjects; or
(b) where no subjects have been enrolled
and no additional risks have been identified;
or
(c) where the remaining research activities
are limited to data analysis.
(9) Continuing review of research, not
conducted under an investigational new drug
application or investigational device
exemption where categories two (2) through
eight (8) do not apply but the IRB has
determined and documented at a convened
meeting that the research involves no greater
than minimal risk and no additional risks
have been identified.
In addition to requesting comments
on all of the expedited review categories
listed above, OHRP specifically requests
comments on a recommendation by
SACHRP to revise expedited review
category 7 as follows:
Research (a) on individual or group
characteristics or behavior (including, but not
limited to, research on perception, cognition,
motivation, affective states, interpersonal
relationships, identity, language,
communication, cultural beliefs or practices,
and social behavior); or (b) employing
methods commonly used in social,
behavioral, epidemiologic, health services
and educational research (including, but not
limited to, survey, interview, oral history,
participant observation, ethnographic, focus
group, program evaluation, human factors
evaluation, or quality assurance methods).
(Note: Some research in this category may be
exempt from the HHS regulations for the
protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers
only to research that is not exempt.)
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Dated: October 22, 2007.
Ivor A. Pritchard,
Acting Director, Office for Human Research
Protections.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–091]
Notice of Public Meeting
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the following meeting on
updating the NIOSH publication
‘‘Occupational Exposure Sampling
Strategies Manual’’.
The document can be found at
https://www.cdc.gov/niosh/docs/77–173/
.
Instructions are provided for
submitting comments.
Public Meeting Dates and Times:
November 8, 2007, 8:30 a.m. to 4:30
p.m. EST and November 9, 2007, 8:30
a.m. to 12 p.m. EST.
Place: Washington Court Hotel, 525
New Jersey Avenue, NW., Washington,
DC 20001.
Purpose of Meeting: To obtain input
from stakeholders on their needs for
information and guidance to be
included in a revision of the
‘‘Occupational Exposure Sampling
Strategies Manual’’ (OESSM), which is
sometimes referred to as ‘‘Leidel, Busch
and Lynch’’ or ‘‘The NIOSH Yellow
Book’’ [https://www.cdc.gov/niosh/77–
173.html].
Status: The forum will include
scientists and representatives from
various government agencies, industry,
labor, and other stakeholders, and is
open to the public, limited only by the
space available. Persons wanting to
attend and contribute comments at the
meeting are requested to register at
https://www.team-psa.com/nioshOESSM07/home.asp no later than
November 1, 2007. Unreserved walk-in
attendees will be accommodated on the
day of the meeting if space is available.
The meeting has several scheduled
presentations and panels that will
include time for questions and answers.
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In addition, two breakout sessions will
be held to solicit discussion and input
on specific occupational exposure
issues.
Presentations, questions, and oral
comments given at the meeting will be
recorded and included in the docket.
Written comments will also be accepted
at the meeting. Written comments may
also be submitted to Diane Miller,
Robert A. Taft Laboratories, 4676
Columbia Parkway, MS C–34,
Cincinnati, Ohio 45226, telephone 513/
533–8611. All material submitted to the
Agency should reference docket number
NIOSH–091 and must be submitted by
November 30, 2007 to be considered by
the Agency. All electronic comments
should be formatted as Microsoft Word.
Please make reference to docket number
NIOSH–091.
NIOSH seeks to obtain materials,
including published and unpublished
reports and research findings, relevant
to the current practice, limitations, and
needs for development of occupational
exposure assessment practices and
policies.
NIOSH will use this information to
assess the needs and scientific basis for
revisions to its guidance and
recommendations in occupational
exposure assessment.
Contact Person for Technical
Information: Paul Middendorf,
telephone (513)533–8606, M/S C–9,
Robert A. Taft Laboratories, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
Contact Person for Submitting
Comments/Meeting Attendance: Diane
Miller, Robert A. Taft Laboratories, 4676
Columbia Parkway, MS C–34,
Cincinnati, Ohio 45226, telephone 513/
533–8611. All material submitted to the
Agency should reference docket number
NIOSH–091.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Cincinnati, Ohio 45226.
Dated: October 18, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–2088–92 and
CMS–10244]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Agency: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Outpatient
Rehabilitation Provider Cost Report;
Use: In accordance with sections
1815(a), 1833(e) and 1861(v)(1)(A)(ii) of
the Social Security Act, providers of
service in the Medicare program are
required to submit annual information
to achieve reimbursement for health
care services rendered to Medicare
beneficiaries. Section 42 CFR 413.20(b)
requires that cost reports be required
from providers on an annual basis. Such
cost reports are required to be filed with
the provider’s fiscal intermediary. The
CMS 2088–92 cost report is needed to
determine the amount of reimbursable
cost that is due these providers for
furnishing medical services to Medicare
beneficiaries. Form Number: CMS–
2088–92 (OMB#: 0938–0037);
Frequency: Reporting—Yearly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 623; Total Annual
Responses: 623; Total Annual Hours:
62,300.
2. Type of Information Collection
Request: New Collection; Title of
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Pages 60848-60851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21126]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Protection of Human Subjects: Categories of Research That May Be
Reviewed by the Institutional Review Board Through an Expedited Review
Procedure
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
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SUMMARY: The Office for Human Research Protections (OHRP) is requesting
written comments on a proposed amendment to item 5 of the categories of
research that may be reviewed by the institutional review board (IRB)
through an expedited review procedure, last published in the Federal
Register on November 9, 1998 (63 FR 60364). On that date, the Office
for Protection from Research Risks (OPRR), now OHRP, and the Food and
Drug Administration (FDA) simultaneously published identical lists of
categories of research activities involving human subjects which may be
reviewed by the IRB through an expedited review procedure. It has come
to OHRP's attention that there has been confusion in the research
community about expedited review category 5. OHRP is proposing to amend
expedited review category 5 to clarify that the category includes
research involving materials that were previously collected for either
nonresearch or research purposes, provided that any materials collected
for research were not collected for the currently proposed research.
Expedited review category 5 also includes research involving materials
that will be collected solely for nonresearch purposes.
In addition, OHRP is requesting comments on the entire expedited
review list that was last published in the Federal Register on November
9, 1998 (63 FR 60364) to determine if other changes are needed.
As part of its charge to provide expert advice and recommendations
to the Secretary of Health and Human Services (the Secretary) and the
Assistant Secretary for Health on issues and topics pertaining to or
associated with the protection of human research subjects, the
Secretary's Advisory Committee on Human Research Protections (SACHRP),
through its Subcommittee on Subpart A, considered whether the current
expedited review categories should be modified. On March 14, 2007,
SACHRP submitted recommendations regarding expedited review to the
Secretary, and on June 18, 2007, the Secretary sent a letter to the
SACHRP chairperson, stating that HHS would give serious consideration
to these recommendations. In regard to the current expedited review
categories, SACHRP recommended that expedited review category 7 should
be revised as described in Section V below. Therefore, in addition to
requesting comments on the entire expedited review list that was
published in the Federal Register on November 9, 1998 (63 FR 60364),
OHRP is also specifically requesting comments on SACHRP's recommended
revision of expedited review category 7.
As required under 21 CFR 56.110(a), FDA also will publish in the
Federal Register a list of categories of research that may be reviewed
by the IRB through an expedited review procedure. FDA intends to issue
the list concurrently with OHRP's issuance of its final notice, and in
compliance with 21 CFR 10.115 (good guidance practice regulations).
This approach maintains FDA's practice of moving in tandem on this
issue with OHRP.
DATES: Submit written or electronic comments by December 26, 2007.
ADDRESSES: Submit written comments to EXPEDITED REVIEW, Office for
Human Research Protections, The Tower Building, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to
expeditedreviewohrp@hhs.gov, or via facsimile at 301-402-2071. Comments
received within the comment period, including any personal information
provided, will be made available to the public upon request.
FOR FURTHER INFORMATION CONTACT: Mr. Glen Drew, Office for Human
Research Protections, The Tower Building, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852, 1-866-447-4777 or by e-mail to:
glen.drew@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Expedited Review Procedures
The Department of Health and Human Services (HHS) human subjects
protection regulations at 45 CFR 46.110 permit expedited review
procedures for certain kinds of human subjects research that have been
found by an IRB to involve no more than minimal risk to research
subjects, or for minor changes in previously IRB-approved research
during the period (of one year or less) for which approval is
authorized. An expedited review procedure consists of a review of
research involving human subjects by the IRB chairperson or by one or
more experienced reviewers designated by the chairperson from among
members of the IRB, in
[[Page 60849]]
accordance with the requirements at 45 CFR 46.110.
The HHS regulations at 45 CFR 46.110 also give the Secretary the
authority to amend and republish the list of research categories that
may be reviewed by the IRB through an expedited review procedure, after
consultation with other departments and agencies. This same section of
the HHS regulations also requires that an amended expedited review list
be published by the Secretary in the Federal Register.
As required by HHS regulations at 45 CFR 46.110, this proposed
amendment of expedited review category 5 was developed after consulting
with the other Federal departments and agencies that have promulgated
the Federal Policy for the Protection of Human Subjects.
II. Background on the Expedited Review List
The first expedited review list was published by the Secretary in
1981 (46 FR 8392). On November 10, 1997, OPRR, now OHRP, and FDA
published identical proposed revisions to the 1981 expedited review
list (published for OPRR at 62 FR 60607). The category of research in
question, expedited review category 5, was addressed in the proposed
categories 4 and 5 in the November 10, 1997 Federal Register Notices
requesting public comment. In those Notices, proposed categories 4 and
5 were presented as follows:
(4) Research involving existing identifiable data, documents,
records, or biological specimens (including pathological or
diagnostic specimens) where these materials, in their entirety, have
been collected prior to the research, for a purpose other than the
proposed research.
(5) Research involving solely (a) prospectively collected
identifiable residual or discarded specimens, or (b) prospectively
collected identifiable data, documents, or records, where (a) or (b)
has been generated for nonresearch purposes.
In addition, a chart included in OPRR's and FDA's November 10, 1997
Federal Register Notices, comparing the proposed expedited review list
with the 1981 list, indicated that the proposed category 4 (see above)
was intended to replace expedited review category 8 on the 1981 list.
Category 8 on the 1981 list stated, ``the study of existing data,
documents, records, pathological specimens, or diagnostic specimens.''
The comments received on OPRR's and FDA's November 10, 1997 Federal
Register Notices overwhelmingly supported the proposed revision to the
expedited review list. With minor modifications to the 1997 proposed
expedited review list, on November 9, 1998, OPRR and FDA simultaneously
published identical revised lists of categories of research activities
that may be reviewed by the IRB through the expedited review procedure
(published for OPRR at 63 FR 60364, and for FDA at 63 FR 60353). In
regard to expedited review category 5, the OPRR and FDA November 9,
1998 Federal Register Notices described this category of research as:
(5) Research involving materials (data, documents, records, or
specimens) that have been collected or will be collected solely for
nonresearch purposes (such as medical treatment or diagnosis).
(Note: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing refers only to research that is not
exempt.)
The preamble of the OPRR November 9, 1998 Federal Register Notice
explained that:
Categories four (4) and five (5) on the proposed list have been
combined into one new category five (5) on the 1998 list. This new
section is added in response to comments that raised questions about
the relationship of proposed categories four (4) and five (5) to
exempt research and about separating out existing and prospectively
collected materials. The term ``nonresearch purposes'' was
maintained in new category five (5) to describe the origins of the
research material * * *
Similarly, the FDA November 9, 1998 Federal Register Notice
explained that:
Categories four and five on the proposed list have been combined
into one new category, category five, addressing research involving
materials collected or which will be collected solely for
nonresearch purposes. This new category five was formed in response
to comments that raised questions about why the two categories
separated out existing and prospectively collected materials. The
term ``nonresearch purposes'' was maintained in new category five to
describe the origins of the research materials.
III. Clarification on the Scope of Expedited Review Category Five (5)
Needed
The description of expedited review category 5 and the preamble
language as published in the November 9, 1998 OPRR and FDA Federal
Register Notices has caused confusion in the research community about
whether this expedited review category includes research involving
materials that were originally collected for either nonresearch or
research purposes, or is limited to research involving materials that
were originally collected solely for nonresearch purposes.
As evidence of this confusion, in their 1999 report, Research
Involving Human Biological Materials: Ethical Issues and Policy
Guidance, the National Bioethics Advisory Commission (NBAC) stated:
NBAC finds that there is no need to distinguish between
collections originally created for clinical purposes and those
created for research purposes. In both cases, research on the
collected materials should be eligible for expedited review if the
research presents no more than a minimal risk to the study subjects.
As a result of this finding, NBAC recommended that ``OPRR should
revise its guidance to make clear that all minimal-risk research
involving human biological materials--regardless of how they were
collected--should be eligible for expedited IRB review.'' In response
to NBAC's 1999 report, HHS convened a multi-agency Working Group to
analyze the appropriateness, feasibility, and practical implications of
implementing NBAC's recommendations and to develop a set of proposed
HHS activities to enhance the protection of human subjects in research
involving human biological materials. In regard to the NBAC
recommendation above, the HHS Working Group stated:
The Working Group concurs with Recommendation 2 and agrees with
NBAC that, for purposes of determining eligibility for expedited IRB
review, it is not necessary to draw a distinction between samples
originally collected for clinical purposes and those obtained for
research purposes. The Working Group also agrees with NBAC's
observation that current guidance regarding the types of research
that IRBs may review through expedited procedures (63 FR 60364 [HHS]
and 60353 [FDA], November 9, 1998) appears to exclude research
utilizing existing specimens previously collected for research
purposes. It is the understanding of the Working Group that this
apparent exclusion is not intentional but rather resulted from a
copy editing oversight * * *
IV. OHRP Assessment
After reviewing OPRR's and FDA's 1997 and 1998 Federal Register
notices concerning revisions to the 1981 expedited review list, NBAC's
recommendation, and the HHS Working Group's response, OHRP has
concluded that expedited review category 5 was intended to, and should,
include research involving existing information or specimens that were
previously collected for nonresearch purposes, as well as research
involving existing information or specimens that were previously
collected for research purposes--provided they were not collected for
the currently proposed research.
OHRP notes that neither OPRR's nor FDA's November 10, 1997 Federal
Register Notice indicated that the proposed expedited review category 4
[[Page 60850]]
was intended to narrow category 8 on the 1981 list to exclude existing
specimens that were collected for research purposes, provided the
materials were collected for a research purpose other than the proposed
research. Because proposed category 4 would have applied to research
involving existing identifiable information or specimens that had been
previously collected for either research or nonresearch purposes,
provided they were not collected for the currently proposed research,
OHRP has concluded that the term ``nonresearch purposes'' was retained
in the final version of category 5 to describe the origins of the
prospectively collected material only, not the origins of the
previously collected material. However, this intent was not made clear
in either OPRR's or FDA's November 9, 1998 Federal Register Notice.
V. OHRP Request for Comments
For the reasons described in Section IV, OHRP is proposing to
revise expedited review category 5 as set forth below.
Remove (5) in its entirety, and add, in its place:
(5) Research involving materials (data, documents, records, or
specimens) that
(a) have previously been collected for nonresearch purposes;
(b) have previously been collected for research purposes, provided
the materials were not collected for the currently proposed research;
or
(c) will be collected solely for nonresearch purposes.
Note: Some research under section (a) or (b) of this category
may be exempt from the HHS regulations for the protection of human
subjects. 45 CFR 46.101(b)(4). This listing refers only to research
that is not exempt.
OHRP is also requesting comments on the entire expedited review
list that was last published in the Federal Register on November 9,
1998 (63 FR 60364) to determine if other changes are needed. The
following is the current expedited review list, as published in the
Federal Register on November 9, 1998:
(1) Clinical studies of drugs and medical devices only when
condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug
application (21 CFR Part 312) is not required. (Note: Research on
marketed drugs that significantly increases the risks or decreases
the acceptability of the risks associated with the use of the
product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational
device exemption application (21 CFR Part 812) is not required; or
(ii) the medical device is cleared/approved for marketing and the
medical device is being used in accordance with its cleared/approved
labeling.
(2) Collection of blood samples by finger stick, heel stick, ear
stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110
pounds. For these subjects, the amounts drawn may not exceed 550 ml
in an 8 week period and collection may not occur more frequently
than 2 times per week; or
(b) from other adults and children,\2\ considering the age,
weight, and health of the subjects, the collection procedure, the
amount of blood to be collected, and the frequency with which it
will be collected. For these subjects, the amount drawn may not
exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection may not occur more frequently than 2 times per week.
(3) Prospective collection of biological specimens for research
purposes by noninvasive means.
Examples: (a) Hair and nail clippings in a nondisfiguring
manner; (b) deciduous teeth at time of exfoliation or if routine
patient care indicates a need for extraction; (c) permanent teeth if
routine patient care indicates a need for extraction; (d) excreta
and external secretions (including sweat); (e) uncannulated saliva
collected either in an unstimulated fashion or stimulated by chewing
gumbase or wax or by applying a dilute citric solution to the
tongue; (f) placenta removed at delivery; (g) amniotic fluid
obtained at the time of rupture of the membrane prior to or during
labor; (h) supra- and subgingival dental plaque and calculus,
provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in
accordance with accepted prophylactic techniques; (i) mucosal and
skin cells collected by buccal scraping or swab, skin swab, or mouth
washings; (j) sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not
involving general anesthesia or sedation) routinely employed in
clinical practice, excluding procedures involving x-rays or
microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the
safety and effectiveness of the medical device are not generally
eligible for expedited review, including studies of cleared medical
devices for new indications.)
Examples: (a) Physical sensors that are applied either to the
surface of the body or at a distance and do not involve input of
significant amounts of energy into the subject or an invasion of the
subject's privacy; (b) weighing or testing sensory acuity; (c)
magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally
occurring radioactivity, electroretinography, ultrasound, diagnostic
infrared imaging, doppler blood flow, and echocardiography; (e)
moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age,
weight, and health of the individual.
(5) Research involving materials (data, documents, records, or
specimens) that have been collected, or will be collected solely for
nonresearch purposes (such as medical treatment or diagnosis).
(Note: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing refers only to research that is not
exempt.)
(6) Collection of data from voice, video, digital, or image
recordings made for research purposes.
(7) Research on individual or group characteristics or behavior
(including, but not limited to, research on perception, cognition,
motivation, identity, language, communication, cultural beliefs or
practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance methodologies. (Note: Some
research in this category may be exempt from the HHS regulations for
the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3).
This listing refers only to research that is not exempt.)
(8) Continuing review of research previously approved by the
convened IRB as follows:
(a) Where (i) the research is permanently closed to the
enrollment of new subjects; (ii) all subjects have completed all
research-related interventions; and (iii) the research remains
active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks
have been identified; or
(c) where the remaining research activities are limited to data
analysis.
(9) Continuing review of research, not conducted under an
investigational new drug application or investigational device
exemption where categories two (2) through eight (8) do not apply
but the IRB has determined and documented at a convened meeting that
the research involves no greater than minimal risk and no additional
risks have been identified.
In addition to requesting comments on all of the expedited review
categories listed above, OHRP specifically requests comments on a
recommendation by SACHRP to revise expedited review category 7 as
follows:
Research (a) on individual or group characteristics or behavior
(including, but not limited to, research on perception, cognition,
motivation, affective states, interpersonal relationships, identity,
language, communication, cultural beliefs or practices, and social
behavior); or (b) employing methods commonly used in social,
behavioral, epidemiologic, health services and educational research
(including, but not limited to, survey, interview, oral history,
participant observation, ethnographic, focus group, program
evaluation, human factors evaluation, or quality assurance methods).
(Note: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that
is not exempt.)
[[Page 60851]]
Dated: October 22, 2007.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections.
[FR Doc. E7-21126 Filed 10-25-07; 8:45 am]
BILLING CODE 4150-36-P
