Published 60 Day FRN

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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices

Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, [email protected].
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 30, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07628 Filed 4–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–15–0576; Docket No. CDC–2015–
0013]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed revision of the
information collection entitled
Possession, Use, and Transfer of Select
Agents and Toxins (OMB Control No.
0920–0576). CDC is requesting Office of
Management and Budget (OMB)
approval to continue to collect
information under the select agent
regulations through the use of five
forms: (1) Application for Registration
for Possession. Use, and Transfer of
Select Agents and Toxins (APHIS/CDC
Form 1); (2) Request to Transfer Select
Agents or Toxins (APHIS/CDC Form 2);
(3) Incident Form to Report Potential
Theft, Loss, Release, or Occupational
Exposure (APHIS/CDC Form 3); (4)
Report of Identification of Select Agent
or Toxin from Clinical/Diagnostic
Specimen, Proficiency Testing, or

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Seizure by Federal Law Enforcement
(APHIS/CDC Form 4); and (5) Request
for Exemption of Select Agents and
Toxins for an Investigational Product
(APHIS/CDC Form 5).
DATES: Written comments must be
received on or before June 2, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0013 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT:

To

request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the

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agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Possession, Use, and Transfer of
Select Agents and Toxins (OMB Control
No. 0920–0576, Expiration—11/30/
2015)—Revision—Office of Public
Health Preparedness and Response
(OPHPR), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Subtitle A of the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002, (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 that have the
potential to pose a severe threat to
public health and safety (select agents
and toxins). Subtitle B of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(which may be cited as the Agricultural
Bioterrorism Protection Act of 2002), (7
U.S.C. 8401), requires the United States
Department of Agriculture (USDA) to
regulate the possession, use, and
transfer of biological agents or toxins
that have the potential to pose a severe
threat to animal or plant health, or
animal or plant products (select agents
and toxins). Accordingly, HHS and
USDA have promulgated regulations
requiring individuals or entities that
possess, use, or transfer select agents
and toxins to register with the CDC or

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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
the Animal and Plant Health Inspection
Service (APHIS). See 42 CFR part 73, 7
CFR part 331, and 9 CFR part 121 (the
select agent regulations). The Federal
Select Agent Program (FSAP) is the
collaboration of the CDC, Division of
Select Agents and Toxins (DSAT) and
the APHIS Agriculture Select Agent
Services (AgSAS) to administer the
select agent regulations in a manner to
minimize the administrative burden on
persons subject to the select agent
regulations. The FSAP administers the
select agent regulations in close
coordination with the Federal Bureau of
Investigation’s Criminal Justice
Information Services (CJIS).
Accordingly, CDC and APHIS have
adopted an identical system to collect
information for the possession, use, and
transfer of select agents and toxins.
CDC is requesting OMB approval to
continue to collect information under
the select agent regulations through the
use of five forms: (1) Application for
Registration for Possession. Use, and
Transfer of Select Agents and Toxins
(APHIS/CDC Form 1); (2) Request to
Transfer Select Agents or Toxins
(APHIS/CDC Form 2); (3) Incident Form
to Report Potential Theft, Loss, Release,
or Occupational Exposure (APHIS/CDC

4. An individual or entity may request
approval to perform a ‘‘restricted
experiment’’ (42 CFR 73.13).

Form 3); (4) Report of Identification of
Select Agent or Toxin from Clinical/
Diagnostic Specimen, Proficiency
Testing, or Seizure by Federal Law
Enforcement (APHIS/CDC Form 4); and
(5) Request for Exemption of Select
Agents and Toxins for an Investigational
Product (APHIS/CDC Form 5).
An entity may amend its registration
(42 CFR 73.7(h)(1)) if any changes occur
to the information previously submitted
to CDC. When applying for an
amendment to a certificate of
registration, an entity would complete
the relevant portion of the application
package (APHIS/CDC Form 1).
Besides the forms listed above, there
is no standard form for the following
information:
1. An individual or entity may request
an exclusion from the requirements of
the select agent regulations of an
attenuated strain of a select agent or a
select toxin modified to be less potent
or toxic. (42 CFR 73.3(e) and 73.4(e)).
2. Annual inspections that are
conducted by the entity must be
documented. (42 CFR 73.9(a)(6)).
3. An individual’s security risk
assessment may be expedited upon
written request by a Responsible Official
and a showing of good cause. (42 CFR
73.10(f)).

5. An individual or entity must
develop and implement a written
security plan, biosafety plan, and
incident response plan (42 CFR 73.11(a),
42 CFR 73.12(a), and 42 CFR 73.14(a)).
6. The Responsible Official at the
must ensure a record of the training for
each individual with access to select
agents and toxins and each escorted
individual is maintained (42 CFR
73.15(d)).
7. An individual or entity may appeal
a denial, revocation, or suspension of
registration. (42 CFR 73.20(a)).
8. An individual may appeal a denial,
limitation, or revocation of access
approval. (42 CFR 73.20(b)).
The total estimated annualized
burden for all data collection was
calculated using data obtained from the
FSAP database and is estimated as 8,528
hours. Information will be collected via
fax, email and hard copy mail from
respondents. Upon OMB approval, CDC
will begin use of the revised forms in
November 2015 through November
2018. There is no cost to the
respondents.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Section

Form name

73.3 & 73.4 .......
73.5 & 6 ............
73.5 & 73.6 .......
73.7 ...................
73.7 ...................
73.9 ...................
73.10 .................
73.11 .................
73.12 .................
73.13 .................
73.14 .................
73.15 .................
73.16 .................
73.17 .................
73.19 .................
73.20 .................

Request for Exclusions .....................................................
Report of Identification of a Select Agent or Toxin ..........
Request of Exemption ......................................................
Application for Registration ..............................................
Amendment to a Certificate of Registration .....................
Documentation of self-inspection .....................................
Request for Expedited Review .........................................
Security Plan ....................................................................
Biosafety Plan ...................................................................
Request Regarding a Restricted Experiment ...................
Incident Response Plan ...................................................
Training .............................................................................
Request to Transfer Select Agents and Toxins ...............
Records ............................................................................
Notification of Theft, Loss, or Release .............................
Administrative Review ......................................................

3
303
1
5
277
277
1
277
277
20
277
277
156
277
215
5

1
3
1
1
7
1
1
1
1
2
1
1
2
1
2
4

1
1
1
5
1
1
30/60
5
5
1
5
1
1
30/60
1
1

3
909
1
25
1,939
277
1
1,385
1,385
40
1,385
277
312
139
430
20

Total ...........

...........................................................................................

........................

........................

........................

8,528

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–07606 Filed 4–2–15; 8:45 am]
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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2187]

Identifying Potential Biomarkers for
Qualification and Describing Contexts
of Use To Address Areas Important to
Drug Development; Extension of
Comment Period
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice; extension of comment

period.
The Food and Drug
Administration (FDA) is extending the
comment period for the notice entitled
‘‘Identifying Potential Biomarkers for
Qualification and Describing Contexts of
Use to Address Areas Important to Drug
Development; Request for Comments’’
that appeared in the Federal Register of
February 13, 2015 (80 FR 8089). In the
notice, FDA requested comments on
identifying potential biomarkers for
qualification and describing contexts of
use to address areas important to drug
development. The Agency is taking this
action for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit either electronic or
written comments by May 15, 2015
ADDRESSES: Submit electronic
comments to http://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Marianne Noone, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4528,
Silver Spring, MD 20993–0002, 301–
796–7495.
SUMMARY:

SUPPLEMENTARY INFORMATION:

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I. Background
In the Federal Register of February
13, 2015 (80 FR 8089), FDA published
a notice with a 60-day comment period
to request comments on identifying
potential biomarkers for qualification
and describing contexts of use to
address areas important to drug
development. FDA is encouraging
interested groups and individuals to
submit information on specific medical
and biological areas where novel
biomarkers can be identified that would

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meaningfully advance drug
development.
The current 60-day comment period
does not allow sufficient time to obtain
the broad public response that will
inform FDA’s Biomarker Qualification
Program going forward. FDA is
extending the comment period for an
additional 30 days, thus extending the
comment period to May 15, 2015. The
Agency believes that a 30-day extension
allows adequate time for interested
persons to submit comments without
significantly delaying progress on these
important issues.

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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2015–07639 Filed 4–2–15; 8:45 am]
BILLING CODE 4163–18–P

II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to http://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at http://
www.regulations.gov.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07631 Filed 4–2–15; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
Correction: This notice was published
in the Federal Register on March 24,
2015, Volume 80, Number 56, Pages
15621–15622. The times and dates
should read as follows:
Times and Dates: 12:30 p.m.—5:00
p.m., April 15, 2015; 8:30 a.m.—12:00
p.m., April 16, 2015.
CONTACT PERSON FOR ADDITIONAL
INFORMATION: Nancy Anderson, Chief,

Laboratory Practice Standards Branch,
Division of Laboratory Programs,
Standards, and Services, Center for
Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, CDC, 1600
Clifton Road NE., Mailstop F–11,
Atlanta, Georgia 30329–4018; telephone
(404) 498–2741; or via email at
[email protected]

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DEPARTMENT OF HOMELAND
SECURITY
United States Immigration and
Customs Enforcement
Agency Information Collection
Activities: Extension, With Change, of
an Existing Information Collection;
Comment Request
60-Day Notice of Information
collection for review; I–312/I–312A;
Designation of Attorney in Fact/
Revocation of Attorney In Fact; OMB
Control No. 1653–0041.

ACTION:

The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (ICE), is submitting the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published in the Federal Register to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for
sixty days until June 2, 2015.
Written comments and suggestions
regarding items contained in this notice
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), Scott Elmore, Forms
Management Office, U.S. Immigration
and Customs Enforcement, 801 I Street
NW., Mailstop 5800, Washington, DC
20536–5800.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the

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