Meeting of the Secretary's Advisory Committee on Human Research Protections, 56233-56234 [2013-22236]
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56233
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
[New burdens associated with the final rule]
Average
number of
responses per
respondent
Number of
respondents
Average
burden hours
per
response
Total burden
hours
Section
Type of respondent
164.520 ...................................................
Dissemination of Notice of Privacy Practices for Protected
Health Information (health
plans).
Revision of Notice of Privacy
Practices (providers).
20,000,000
1
.00333335
66,667
697,000
1
.11111
77,444
.....................................................
........................
........................
........................
619,278
164.520 ...................................................
Total ................................................
ONGOING ANNUAL BURDENS OF COMPLIANCE WITH THE RULES
Type of respondent
160.204 .............
Process for Requesting Exception Determinations
(states or persons).
Uses and Disclosures—Organizational Requirements ....
Uses and Disclosures for Which Individual authorization
is required.
Uses and Disclosures for Research Purposes ................
Notice of Privacy Practices for Protected Health Information (health plans—periodic distribution of NPPs by
paper mail).
Notice of Privacy Practices for Protected Health Information (health plans—periodic distribution of NPPs by
electronic mail).
Notice of Privacy Practices for Protected Health Information (health care providers—dissemination and acknowledgement).
Rights to Request Privacy Protection for Protected
Health Information.
Access of Individuals to Protected Health Information
(disclosures).
Amendment of Protected Health Information (requests)
Amendment of Protected Health Information (denials) ....
Accounting for Disclosures of Protected Health Information.
164.504 .............
164.508 .............
164.512 .............
164.520 .............
164.520 .............
164.520 .............
164.522 .............
164.524 .............
164.526 .............
164.526 .............
164.528 .............
Total ...........
...........................................................................................
Total Hours: 32,762,920.
Darius Taylor,
Deputy Information Collection Clearance
Officer.
[FR Doc. 2013–22148 Filed 9–11–13; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Office of the Secretary
National Foundation on Fitness,
Sports, and Nutrition Establishment
Act; Delegation of Authority; Office of
the Assistant Secretary for Health
Notice is hereby given that I have
delegated to the Assistant Secretary for
Health authority under Section 5 of the
National Foundation on Fitness, Sports,
VerDate Mar<15>2010
19:54 Sep 11, 2013
Jkt 229001
Number of
responses per
respondent
Number of
respondents
Section
1
16
16
700,000
700,000
1
1
5/60
1
58,333
700,000
113,524
100,000,000
1
1
5/60
0.25
9,460
416667
100,000,000
1
0.167
278333
613,000,000
1
3/60
30,650,000
150,000
1
3/60
7,500
150,000
1
3/60
7,500
150,000
50,000
70,000
1
1
1
3/60
3/60
3/60
7,500
2,500
5,833
........................
........................
........................
32,143,642
Dated: September 6, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–22235 Filed 9–11–13; 8:45 am]
BILLING CODE 4150–35–P
Frm 00032
Fmt 4703
Total burden
hours
1
and Nutrition Establishment Act, Public
Law 111–332 (Dec. 22, 2010). The
delegation excludes the authorities to
issue regulations and to submit reports
to the Congress. This authority may be
re-delegated.
I hereby affirm and ratify any actions
taken by the Assistant Secretary for
Health, or his subordinates, which
involved the exercise of this authority
delegated herein prior to the effective
date of this delegation of authority.
This delegation is effective upon date
of signature.
PO 00000
Average
burden hours
per response
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP and the full
meeting agenda will be posted on the
SUMMARY:
E:\FR\FM\12SEN1.SGM
12SEN1
56234
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Notices
SACHRP Web site at: https://
www.dhhs.gov/ohrp/sachrp/mtgings/
index.html.
The meeting will be held on
Thursday, October 3, 2013 from 8:30
a.m. until 5:00 p.m. and Friday, October
4, 2013 from 8:30 a.m. until 4:30 p.m.
ADDRESSES: U.S. Department of Health
and Human Services, 200 Independence
Avenue SW., Hubert H. Humphrey
Building, Room 800, Washington, DC
20201.
DATES:
Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; email address:
Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
The meeting will open to the public
at 8:30 a.m., Thursday, October 3.
Following opening remarks from Dr.
Jerry Menikoff, OHRP Director, and Dr.
Jeffrey Botkin, SACHRP Chair, the
Subcommittee on Harmonization (SOH)
will give their report.
SOH was established by SACHRP at
its July 2009 meeting and is charged
with identifying and prioritizing areas
in which regulations and/or guidelines
for human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
Following opening remarks on the
morning of October 4, the Subpart A
Subcommittee (SAS) will give their
report. SAS is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment; this
subcommittee was established by
SACHRP in October 2006.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
tkelley on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
19:54 Sep 11, 2013
Jkt 229001
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
September 30, 2013.
Dated: September 5, 2013.
Jerry Menikoff,
Director, Office for Human Research
Protections,
Executive Secretary, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2013–22236 Filed 9–11–13; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Multi-Agency Informational Meeting
Concerning Compliance with the
Select Agent Regulations; Public
Webcast
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of public webcast.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) announces a public
webcast for all interested parties,
including individuals and entities
possessing, using, or transferring
biological agents and toxins. The
purpose of the webcast is to provide
guidance related to the select agent
regulations established under the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002.
The webcast is being organized by the
U.S. Department of Agriculture
(USDA)’s Animal and Plant Health
Inspection Service (APHIS), HHS/CDC,
and the Department of Justice’s Federal
Bureau of Investigation (FBI), Criminal
Justice Information Services. Changes to
Section 11(Security) of the select agent
regulations including information
security, physical security, and
personnel suitability will be discussed.
Topics will focus on additional
requirements for entities possessing
select agents and toxins designated as
Tier 1 agents.
DATES: The webcast will be held on
Friday, November 15, 2013 from 10 a.m.
to 4 p.m. EST. All who wish to join the
webcast must register by October 18,
2013. Registration instructions can be
SUMMARY:
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found on the Web site https://
www.selectagents.gov.
ADDRESSES: The webcast will be
broadcast from the APHIS facility, 4700
River Road, Unit 2, Riverdale, MD
20737.
FOR FURTHER INFORMATION CONTACT:
APHIS: Dr. Keith Wiggins, APHIS
Select Agent Program, 4700 River Road,
Unit 2, Riverdale, MD 20737; 301–851–
3300 option 1 (voice only); ASAP@
aphis.usda.gov.
CDC: Diane Martin, Division of Select
Agents and Toxins, Office of Public
Health Preparedness and Response,
CDC, 1600 Clifton Road, NE., MS A–46,
Atlanta, GA 30333; (404) 718–2000;
lrsat@cdc.gov.
SUPPLEMENTARY INFORMATION: Title II of
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002, ‘‘Enhancing
Controls on Dangerous Biological
Agents and Toxins’’ (sections 201
through 221), provides for the regulation
of certain biological agents and toxins
by HHS (subtitle A, sections 201–204)
and USDA (subtitle B, sections 211–
213), and provides for interagency
coordination between the two
departments regarding overlap agents
and toxins (subtitle C, section 221).
HHS/CDC regulates the possession, use
or transfer biological agents and toxins
that have the potential to pose a severe
threat to public health and safety. The
HHS/CDC select agent regulations can
be found at 42 CFR part 73.
USDA/APHIS has a parallel program
that regulates the possession, use or
transfer biological agents that have the
potential to pose a severe threat to
animal or plant health, or to animal or
plant products. The USDA/APHIS select
agent regulations can be found at 7 CFR
part 331 and 9 CFR part 121.
The Criminal Justice Information
Service (CJIS) in the Federal Bureau of
Investigation (FBI) conducts security
risk assessments of all individuals and
nongovernmental entities that require
access to select agents and toxins.
The webcast announced here is an
opportunity for the regulated
community (i.e., registered entity
responsible officials, alternate
responsible officials, and entity owners)
and other interested individuals to
obtain specific regulatory guidance and
information on standards concerning
security issues related to the select agent
regulations. Representatives from HHS/
CDC, USDA/APHIS, and the FBI will be
present during the webcast to address
questions from and concerns of the web
participants.
Changes to Section 11 (Security) of
the select agent regulations including
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]]>Agencies
[Federal Register Volume 78, Number 177 (Thursday, September 12, 2013)]
[Notices]
[Pages 56233-56234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold a
meeting that will be open to the public. Information about SACHRP and
the full meeting agenda will be posted on the
[[Page 56234]]
SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
DATES: The meeting will be held on Thursday, October 3, 2013 from 8:30
a.m. until 5:00 p.m. and Friday, October 4, 2013 from 8:30 a.m. until
4:30 p.m.
ADDRESSES: U.S. Department of Health and Human Services, 200
Independence Avenue SW., Hubert H. Humphrey Building, Room 800,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections (OHRP), or Julia Gorey, J.D.,
Executive Director, SACHRP; U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
240-453-8141; fax: 240-453-6909; email address: Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services and the Assistant Secretary for
Health on issues and topics pertaining to or associated with the
protection of human research subjects.
The meeting will open to the public at 8:30 a.m., Thursday, October
3. Following opening remarks from Dr. Jerry Menikoff, OHRP Director,
and Dr. Jeffrey Botkin, SACHRP Chair, the Subcommittee on Harmonization
(SOH) will give their report.
SOH was established by SACHRP at its July 2009 meeting and is
charged with identifying and prioritizing areas in which regulations
and/or guidelines for human subjects research adopted by various
agencies or offices within HHS would benefit from harmonization,
consistency, clarity, simplification and/or coordination.
Following opening remarks on the morning of October 4, the Subpart
A Subcommittee (SAS) will give their report. SAS is charged with
developing recommendations for consideration by SACHRP regarding the
application of subpart A of 45 CFR part 46 in the current research
environment; this subcommittee was established by SACHRP in October
2006.
Public attendance at the meeting is limited to space available.
Individuals who plan to attend the meeting and need special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify the designated contact persons. Members
of the public will have the opportunity to provide comments on both
days of the meeting. Public comment will be limited to five minutes per
speaker. Any members of the public who wish to have printed materials
distributed to SACHRP members for this scheduled meeting should submit
materials to the Executive Director, SACHRP, prior to the close of
business September 30, 2013.
Dated: September 5, 2013.
Jerry Menikoff,
Director, Office for Human Research Protections,
Executive Secretary, Secretary's Advisory Committee on Human
Research Protections.
[FR Doc. 2013-22236 Filed 9-11-13; 8:45 am]
BILLING CODE 4150-36-P
