Agency Forms Undergoing Paperwork Reduction Act Review, 39702-39704 [E8-15749]
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39702
Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–07BN]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC, or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Study to Assess Hepatitis Risk
(STAHR)—New—National Center for
AIDS Viral Hepatitis and TB Prevention,
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Hepatitis C is the most prevalent
bloodborne infection in the United
States. Approximately 3.2 million
persons are chronically infected with
hepatitis C virus (HCV).
Identifying and reaching persons at
risk for HCV infection is critical to
prevent infection. Currently the Centers
for Disease Control and Prevention
(CDC) monitor the national incidence of
acute hepatitis C through passive
surveillance of acute, symptomatic cases
of laboratory confirmed hepatitis C
cases. However, only a small group of
people with acute infection exhibit
symptoms (<25%). Passive surveillance
only captures a small fraction of acutely
infected people. Injection drug users
(IDUs) are the primary risk group for
acute hepatitis C. Thus, it is necessary
to consider strategies other than passive
surveillance for incidence monitoring.
One such strategy is to conduct serial
cross-sectional seroprevalence surveys
among populations at increased risk of
infection. Better methods of
identification of persons at risk will
enhance current surveillance efforts.
The purpose of the proposed study is
to develop and test different methods to
recruit a sample of young IDUs at risk
for HCV infection. These recruitment
methods will be compared and
contrasted to identify a methodology to
be used in ongoing serial cross-sectional
seroprevalence surveys. CDC is
requesting approval for two years.
Working with the University of
California, San Diego (UCSD), the
project will recruit a total of 1000 young
IDUs during the 2 years using several
methods. These methods are street
outreach, respondent driven sampling
and venue based. They are to be
conducted in a sexually transmitted
disease clinic and syringe exchange
program. Young IDUs who consent to
participate will be administered an
eligibility interview questionnaire by a
trained field staff member. If found
eligible, the participant will take an
audio-computer assisted self interview
that includes questions on drug use and
sexual behavior, HCV and Human
Immunodeficiency Virus (HIV) status,
knowledge of HCV, and missed
opportunities for hepatitis prevention.
The project will also collect blood
samples from each consenting
participant to test for HCV infection and
hepatitis A and B vaccination without
cost. Participants needing medical and/
or drug treatment services will be
referred to the appropriate services.
Participation in the data collection is
voluntary and there is no cost to
respondents other than their time. The
total estimated annual burden hours are
816.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form
Young IDUs .....................................................
Eligible young IDUs ........................................
Screener .........................................................
Survey ............................................................
Dated: July 1, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–15630 Filed 7–9–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Project
jlentini on PROD1PC65 with NOTICES
[30Day–08–0576]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
VerDate Aug<31>2005
16:58 Jul 09, 2008
Jkt 214001
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Possession, Use, and Transfer of
Select Agents and Toxins (OMB Control
No. 0920–0576)—Revision—Division of
Select Agents and Toxins (DSAT),
Coordinating Office for Terrorism
Preparedness and Emergency Response
(COTPER), Centers for Disease Control
and Prevention (CDC). The revisions to
the data collection are primarily
PO 00000
Frm 00057
Fmt 4703
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1000
800
Number of
responses per
respondent
Average
burden
per response
(in hours)
1
1
5/60
55/60
changes to the guidance documents and
forms to clarify instructions, correct
editorial errors from previous
submission, and reformat the structure
of the forms based on the day-to-day
processing of these forms. This request
is for approval for three years.
Background and Brief Description
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002, Subtitle A of
Public Law 107–188 (42 U.S.C. 262a),
requires the United States Department
of Health and Human Services (HHS) to
regulate the possession, use, and
transfer of biological agents or toxins
(i.e., select agents and toxins) that could
pose a severe threat to public health and
safety. The Agricultural Bioterrorism
Protection Act of 2002, Subtitle B of
Public Law 107–188 (7 U.S.C. 8401),
E:\FR\FM\10JYN1.SGM
10JYN1
39703
Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Notices
requires the United States Department
of Agriculture (USDA) to regulate the
possession, use, and transfer of
biological agents or toxins (i.e., select
agents and toxins) that could pose a
severe threat to animal or plant health,
or animal or plant products. In
accordance with these Acts, HHS and
USDA promulgated regulations
requiring entities to register with the
CDC or the Animal and Plant Health
Inspection Service (APHIS) if they
possess, use, or transfer a select agent or
toxin (42 CFR part 73, 7 CFR part 331,
and 9 CFR part 121). CDC and APHIS
coordinate regulatory activities for those
agents that would be regulated by both
agencies (‘‘overlap’’ select agents). CDC
and APHIS adopted an identical system
to collect information for the
possession, use, and transfer of select
agents and toxins.
CDC is requesting continued OMB
approval to collect this information
through the use of five forms. The forms
are: (1) Application for Registration, (2)
Request to Transfer Select Agent or
Toxin, (3) Report of Theft, Loss, or
Release of Select Agent and Toxin, (4)
Report of Identification of Select Agent
or Toxin, and (5) Request for
Exemption. The Application for
Registration (42 CFR, 73.7(d)) will be
used by entities to register with CDC.
Entities may amend their registration
(42 CFR, 73.7(h)1)) if any changes occur.
The Request to Transfer Select Agent
or Toxin form (42 CFR 73.16) will be
used to request transfer of a select agent
or toxin to their facility. CDC, with
APHIS, has revised the form by
requiring the recipient to submit the
initial request, be notified by the sender
of the expected shipment date, and
verify if the shipment did not occur.
The Report of Theft, Loss, or Release
of Select Agent and Toxin form (42 CFR
73.19(a)(b)) must be completed by
entities if there is theft, loss, or release
of a select agent or toxin. The Report of
Identification of Select Agent or Toxin
form 42 CFR 73.5(a)(b) and 73.6(a)(b))
will be used by clinical and diagnostic
laboratories to notify CDC that select
agents or toxins identified as the result
of diagnostic or proficiency testing have
been disposed of in a proper manner.
The form will be used by Federal law
enforcement agencies to report the
seizure and final disposition of select
agents and toxins. CDC has revised the
Report of Identification of Select Agent
or Toxin form to ensure duplicate
reports are not submitted by requesting
the entity that makes the final
identification report the select agents or
toxins identified as the result of
diagnostic or verification testing.
The Request for Exemption form (42
CFR 73.5(d)(e) and 73.6(d)(e)) will be
used by entities that use an
investigational product that are, bear, or
contain select agents or toxins or in
cases of public health emergency. An
entity may apply to HHS for an
exclusion of an attenuated strain of a
select agent or toxin that does not pose
a severe threat to public health and
safety (42 CFR 73.3(e)(1) and 73.4(e)(1)).
This regulation outlines situations in
which an entity must notify or may
make a request of HHS in writing. An
entity may apply to the HHS Secretary
for an expedited review of an individual
by the Attorney General (42 CFR
73.10(e)). CDC has not developed
standardized forms for these situations.
The entity should provide the
information in the appropriate section
of the regulation.
As part of the requirements of the
Responsible Official, the Responsible
Official is required to conduct regular
inspections (at least annually) of the
laboratory where select agents or toxins
are stored. Results of these selfinspections must be documented (42
CFR 73.9(a)(5)).
As part of the training requirements of
this regulation, the entity is required to
record the identity of the individual
trained, the date of training, and the
means used to verify that the employee
understood the training (42 CFR
73.15(c)).
An individual or entity may request
administrative review of a decision
denying or revoking certification of
registration or an individual may appeal
a denial of access approval (42 CFR
73.20). An entity must implement a
system to ensure certain records and
databases are accurate and that the
authenticity of records may be verified
(42 CFR 73.17(b).
Prior to issuance of a certificate of
registration, CDC inspects entities to
ensure compliance with this regulation
(42 CFR 73.18).
The estimated annual burden is 9,657
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
CFR reference
Data collection
73.7(d) .............................................................
73.7(h)(1) ........................................................
73.19(a)(b) ......................................................
73.5 & 73.6(d–e)/73.3 & 73.4(e)(1) ................
73.16 ...............................................................
73.5 & 73.6(a)(b) .............................................
Registration Application .................................
Amendment to Registration Application .........
Notification of Theft, Loss, or Release form ..
Request for Exemption/Exclusion ..................
Request to Transfer Select Agent or Toxin ...
Report of Identification of Select Agent or
Toxin form.
Request expedited review ..............................
Documentation of self-inspection ...................
Documentation of training ..............................
Administrative Review ....................................
Ensure secure recordkeeping system ...........
Inspections .....................................................
jlentini on PROD1PC65 with NOTICES
73.10(e) ...........................................................
73.9(a)(5) ........................................................
73.15(c) ...........................................................
73.20 ...............................................................
73.17 ...............................................................
73.18 ...............................................................
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E:\FR\FM\10JYN1.SGM
Average
burden
per response
(in hours)
Responses
per
respondent
5
264
60
5
264
264
1
5
1
1
4
10
4.5
1
1
1
1.5
1
10
264
264
15
264
264
1
1
1
1
1
1
30/60
1
2
4
4
8
10JYN1
39704
Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Notices
Dated: July 2, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–15749 Filed 7–9–08; 8:45 am]
BILLING CODE 4163–18–P
Carl
Rubenstein, Wilson-Fish Program
Manager, Office of Refugee
Resettlement, Aerospace Building, 8th
Floor West, 901 D Street, SW.,
Washington, DC 20447. Telephone:
202–205–5933.
FOR FURTHER INFORMATION CONTACT:
Dated: July 1, 2008.
David H. Siegel,
Acting Director, Office of Refugee
Resettlement.
[FR Doc. E8–15633 Filed 7–9–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
BILLING CODE 4184–01–P
Office of Refugee Resettlement
Office of Refugee Resettlement,
Administration for Children and
Families.
ACTION: Single-Source Program
Expansion Supplement.
jlentini on PROD1PC65 with NOTICES
AGENCY:
CFDA#: 93.583.
Legislative Authority: The Refugee Act
of 1980 as amended, Wilson-Fish
Amendment, 8 U.S.C. 1522(e)(7);
section 412(e)(7)(A) of the Immigration
and Nationality Act.
Amount of Award: $1,312,414
supplement for current year.
Project Period: 09/30/2005–09/29/
2010.
Justification for the Exception to
Competition: The Wilson-Fish program
is an alternative to the traditional Stateadministered welfare system for
providing integrated assistance and
services to refugees, asylees, Amerasian
Immigrants, Cuban and Haitian
Entrants, and Trafficking Victims. San
Diego County is one of 12 sites that has
chosen this alternative approach.
The supplemental funds will allow
the grantee, Catholic Charities Diocese
of San Diego, to provide refugee cash
assistance through the end of this fiscal
year to eligible refugees (and others
eligible for refugee benefits) under the
San Diego Wilson-Fish Program.
The primary reason for the grantee’s
supplemental request is a higher
number of arrivals than anticipated
when the grantee’s budget was
submitted and approved last year. The
Refugee Act of 1980 mandates that the
Office of Refugee Resettlement (ORR)
reimburse States and Wilson-Fish
projects for the costs of cash and
medical assistance for newly arriving
refugees. Since 1991, ORR has
reimbursed States and Wilson-Fish
agencies for providing cash and medical
assistance to eligible individuals during
their first eight months in the United
States.
Hence, the supplement is consistent
with the purposes of the Wilson-Fish
Program, the Refugee Act of 1980, and
ORR policy.
VerDate Aug<31>2005
16:58 Jul 09, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0381]
Draft Guidance for Industry on
Voluntary Third-Party Certification
Programs for Foods and Feeds;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Voluntary ThirdParty Certification Programs for Foods
and Feeds.’’ This draft guidance
describes the general attributes FDA
believes a voluntary third-party
certification program should have in
order to help ensure its certification is
a reliable reflection that the foods and
feeds from certified establishments are
safe and meet applicable FDA
requirements.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by September 8, 2008.
ADDRESSES: Submit written comments
on the draft 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 draft guidance
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sharon Lindan Mayl, Food and Drug
Administration, 5600 Fishers Lane (HF–
11), Rockville, MD 20857, 301–827–
3360.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Voluntary Third-Party Certification
Programs for Foods and Feeds.’’ This
draft guidance is issued in response to
the recommendations contained in the
Action Plan for Import Safety: A
Roadmap for Continual Improvement
(Action Plan) issued on November 6,
2007, by the Interagency Working Group
on Import Safety (Working Group)
established by Executive Order 13439,
as well as FDA’s Food Protection Plan
released on the same date. Both those
plans emphasize certification as a way
to help verify the safety of products
from a growing food establishment
inventory, both domestic and foreign.
In the Federal Register of April 2,
2008 (73 FR 17989), FDA issued a notice
requesting comments on the use of
third-party certification programs for
foods and animal feeds. FDA received
approximately 70 comments in response
to that notice. The comments were
generally supportive of the use of thirdparty certification programs. Many
encouraged FDA to recognize such
programs as a way to increase
participation and improve the safety
and security of foods.
This draft guidance, when finalized,
will represent FDA’s current thinking
on the certification process and will
describe the general attributes FDA
believes a voluntary third-party
certification program should have in
order to provide FDA with confidence
in that program. If FDA has such
confidence, we may choose to recognize
the program and provide incentives for
establishments to obtain certification by
recognized certification programs.
Recognition in this context means that
FDA has determined that certification
may be a reliable reflection that the
foods from the certified establishment
are safe and meet applicable FDA
requirements. Such recognition would
be tailored to particular categories of
products and would occur in a separate
document that builds upon the general
attributes set forth in this document.
Therefore, this draft guidance is
intended as one of the steps in FDA’s
future recognition of one or more
voluntary third-party certification
programs for particular product types.
To further that process, FDA is also
announcing, in a separate notice issued
in this Federal Register, a voluntary
pilot program for third-party
certification bodies that certify foreign
processors of aquacultured shrimp. This
pilot is intended to gather technical and
operational information that will assist
E:\FR\FM\10JYN1.SGM
10JYN1
]]>Agencies
[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Notices]
[Pages 39702-39704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15749]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-0576]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Possession, Use, and Transfer of Select Agents and Toxins (OMB
Control No. 0920-0576)--Revision--Division of Select Agents and Toxins
(DSAT), Coordinating Office for Terrorism Preparedness and Emergency
Response (COTPER), Centers for Disease Control and Prevention (CDC).
The revisions to the data collection are primarily changes to the
guidance documents and forms to clarify instructions, correct editorial
errors from previous submission, and reformat the structure of the
forms based on the day-to-day processing of these forms. This request
is for approval for three years.
Background and Brief Description
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C.
262a), requires the United States Department of Health and Human
Services (HHS) to regulate the possession, use, and transfer of
biological agents or toxins (i.e., select agents and toxins) that could
pose a severe threat to public health and safety. The Agricultural
Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188
(7 U.S.C. 8401),
[[Page 39703]]
requires the United States Department of Agriculture (USDA) to regulate
the possession, use, and transfer of biological agents or toxins (i.e.,
select agents and toxins) that could pose a severe threat to animal or
plant health, or animal or plant products. In accordance with these
Acts, HHS and USDA promulgated regulations requiring entities to
register with the CDC or the Animal and Plant Health Inspection Service
(APHIS) if they possess, use, or transfer a select agent or toxin (42
CFR part 73, 7 CFR part 331, and 9 CFR part 121). CDC and APHIS
coordinate regulatory activities for those agents that would be
regulated by both agencies (``overlap'' select agents). CDC and APHIS
adopted an identical system to collect information for the possession,
use, and transfer of select agents and toxins.
CDC is requesting continued OMB approval to collect this
information through the use of five forms. The forms are: (1)
Application for Registration, (2) Request to Transfer Select Agent or
Toxin, (3) Report of Theft, Loss, or Release of Select Agent and Toxin,
(4) Report of Identification of Select Agent or Toxin, and (5) Request
for Exemption. The Application for Registration (42 CFR, 73.7(d)) will
be used by entities to register with CDC. Entities may amend their
registration (42 CFR, 73.7(h)1)) if any changes occur.
The Request to Transfer Select Agent or Toxin form (42 CFR 73.16)
will be used to request transfer of a select agent or toxin to their
facility. CDC, with APHIS, has revised the form by requiring the
recipient to submit the initial request, be notified by the sender of
the expected shipment date, and verify if the shipment did not occur.
The Report of Theft, Loss, or Release of Select Agent and Toxin
form (42 CFR 73.19(a)(b)) must be completed by entities if there is
theft, loss, or release of a select agent or toxin. The Report of
Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and
73.6(a)(b)) will be used by clinical and diagnostic laboratories to
notify CDC that select agents or toxins identified as the result of
diagnostic or proficiency testing have been disposed of in a proper
manner. The form will be used by Federal law enforcement agencies to
report the seizure and final disposition of select agents and toxins.
CDC has revised the Report of Identification of Select Agent or Toxin
form to ensure duplicate reports are not submitted by requesting the
entity that makes the final identification report the select agents or
toxins identified as the result of diagnostic or verification testing.
The Request for Exemption form (42 CFR 73.5(d)(e) and 73.6(d)(e))
will be used by entities that use an investigational product that are,
bear, or contain select agents or toxins or in cases of public health
emergency. An entity may apply to HHS for an exclusion of an attenuated
strain of a select agent or toxin that does not pose a severe threat to
public health and safety (42 CFR 73.3(e)(1) and 73.4(e)(1)).
This regulation outlines situations in which an entity must notify
or may make a request of HHS in writing. An entity may apply to the HHS
Secretary for an expedited review of an individual by the Attorney
General (42 CFR 73.10(e)). CDC has not developed standardized forms for
these situations. The entity should provide the information in the
appropriate section of the regulation.
As part of the requirements of the Responsible Official, the
Responsible Official is required to conduct regular inspections (at
least annually) of the laboratory where select agents or toxins are
stored. Results of these self-inspections must be documented (42 CFR
73.9(a)(5)).
As part of the training requirements of this regulation, the entity
is required to record the identity of the individual trained, the date
of training, and the means used to verify that the employee understood
the training (42 CFR 73.15(c)).
An individual or entity may request administrative review of a
decision denying or revoking certification of registration or an
individual may appeal a denial of access approval (42 CFR 73.20). An
entity must implement a system to ensure certain records and databases
are accurate and that the authenticity of records may be verified (42
CFR 73.17(b).
Prior to issuance of a certificate of registration, CDC inspects
entities to ensure compliance with this regulation (42 CFR 73.18).
The estimated annual burden is 9,657 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average burden
CFR reference Data collection Number of Responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
73.7(d)............................... Registration Application 5 1 4.5
73.7(h)(1)............................ Amendment to 264 5 1
Registration
Application.
73.19(a)(b)........................... Notification of Theft, 60 1 1
Loss, or Release form.
73.5 & 73.6(d-e)/73.3 & 73.4(e)(1).... Request for Exemption/ 5 1 1
Exclusion.
73.16................................. Request to Transfer 264 4 1.5
Select Agent or Toxin.
73.5 & 73.6(a)(b)..................... Report of Identification 264 10 1
of Select Agent or
Toxin form.
73.10(e).............................. Request expedited review 10 1 30/60
73.9(a)(5)............................ Documentation of self- 264 1 1
inspection.
73.15(c).............................. Documentation of 264 1 2
training.
73.20................................. Administrative Review... 15 1 4
73.17................................. Ensure secure 264 1 4
recordkeeping system.
73.18................................. Inspections............. 264 1 8
----------------------------------------------------------------------------------------------------------------
[[Page 39704]]
Dated: July 2, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-15749 Filed 7-9-08; 8:45 am]
BILLING CODE 4163-18-P
