FR 60-day Notice

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Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices

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noted that any work involving the
introduction of tetracycline resistance
into Chlamydia by other investigators
would need to be reviewed by the RAC
and specifically approved by the NIH
Director.
Background Information and Response
to Comments
On May 9, 2007, background on the
proposed action, and information on
how to submit public comment, was
published in the Federal Register (72
FR 26415). On June 20, 2007, the RAC
discussed the proposed action at its
quarterly public meeting and reviewed
the one public comment received. The
RAC recommended to the NIH Director
that this work be allowed to proceed
under Biosafety level (BL) 2+
containment with additional provisions/
stipulations. On September 24, 2007,
the NIH Director approved the proposed
experiments with the following
conditions.
(1) Tetracycline resistance will only
be introduced into non-ocular strains of
C. trachomatis. In conducting this work
on tetracycline resistance in C.
trachomatis, the following containment
standard must be followed:
(2) All research involving the
introduction of tetracycline resistance
into C. trachomatis must be performed
at BL 2 using BL3 practices (referred to
as BL2+). The NIH Guidelines
articulates requirements for BL2
laboratory facilities and equipment in
Appendices G–II–B–3 and G–II–B–4
while BL3 practices are described in
Appendices G–II–C–1 and C–2 of the
NIH Guidelines. Specifically, the
following BL3 practices must be
followed:
(a) Access must be restricted to welltrained personnel whose presence is
required for the conduct of this work,
and
(b) The investigators must use sealed
centrifuge rotors and tubes.
(3) In addition, the following
procedures and practices must be
followed:
(a) Cup sonication must be used
rather than probe sonication to separate
the infectious form [elementary bodies
(EB)] from the metabolically active
[reticulate bodies (RB)] form of the
bacterium.
(b) If possible, consider using other
techniques that do not involve the
potential for the generation of aerosols,
such as freeze-thaw, to separate EBs
from RBs.
(c) No work with the Chlamydia
serovars A, B, or C, which cause the
ocular disease trachoma, may be
conducted in the same laboratory in
which tetracycline resistance is being

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introduced into C. trachomatis serovars
that cause genital disease (L, E and G).
(d) An assay to detect the tetracycline
resistant genetic element should be
developed so that, in the event of a
laboratory acquired infection, it will be
possible to determine whether the
genetically modified strain of
Chlamydia is the source of the infection.
(e) The following preventive health
surveillance steps should be
implemented for any member of the
laboratory working with tetracycline
resistant C. trachomatis:
(i) In addition to being trained on
proper biosafety practices, laboratory
workers must be provided education on
the possible clinical manifestations of
laboratory acquired chlamydial
infection.
(ii) Each laboratory must have a
detailed, written action plan outlining
the specific steps to be taken in the case
of a laboratory exposure or infection.
This plan should include at a minimum:
(1) Identification of key personnel
who would provide diagnostic testing
and treatment;
(2) Instructions on managing
exposures or infections discovered
during off hours (after close of business,
holidays, weekends, etc.);
(3) Specific recommendations for
managing azithromycin-allergic or
sensitive lab workers; and a provision
excluding individuals with known
macrolide antibiotic allergies from
working on these experiments;
(4) Specific recommendations for
treatment of infected laboratory
personnel who develop side effects
while being treated with azithromycin,
and
(5) Specific precautions to be taken by
infected laboratory workers with respect
to protecting close contacts (e.g. family
members) from further infection.
(iii) In order to ensure that laboratory
members will receive adequate
healthcare in the event of infection, an
outreach program should be developed
to inform healthcare providers who may
treat laboratory members about the
diagnosis and treatment of tetracyclineresistant Chlamydia. In addition,
members of the laboratory should be
provided with a medical card that
includes at least the following
information:
(1) Identification of the personnel
responsible for providing diagnosis and
treatment;
(2) A CDC telephone number for
reporting the infection and obtaining
treatment recommendations, and
(3) A twenty-four hour contact
number for the principal investigators.
(4) Finally, if tetracycline resistant C.
trachomatis is transferred to other

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laboratories, the investigators working
with this tetracycline resistant
Chlamydia must follow the identical
practices and procedures set forth by the
NIH Director. It is the responsibility of
Dr. Rockey and Dr. Stamm to ensure and
document that the investigators to
whom they transfer these strains are
apprised of and agree to abide by these
requirements. As noted, however, since
the NIH Director’s approval for the de
novo creation of tetracycline resistant
strains of non-ocular serovars of C.
trachomatis applies only to experiments
conducted by Drs. Rockey and Stamm,
any work involving the introduction of
tetracycline resistance into Chlamydia
by other investigators would need to be
reviewed by the RAC and specifically
approved by the NIH Director.
Dated: October 23, 2007.
Amy P. Patterson,
Director, Office of Biotechnology Activities,
National Institutes of Health.
[FR Doc. E7–21404 Filed 10–30–07; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2007–0072]

Science and Technology Directorate;
Submission for Review; DHS S&T BAA
Web Site Registration Form; DHS S&T
BAA Registration Form; DHS S&T BAA
White Paper and Proposal Submission
Form; DHS S&T RFI Response Form
Science and Technology
Directorate, DHS.
ACTION: 30-day Notice and request for
comment.
AGENCY:

SUMMARY: The Department of Homeland
Security (DHS) invites the general
public to comment on new data
collection forms for collecting Request
for Information (RFI) responses and
unclassified white papers and proposals
through the Broad Agency
Announcement (BAA) Web site. The
forms will standardize the collection of
information that is both necessary and
sufficient for the DHS S&T Directorate
to record and track the receipt of RFI
responses, unclassified white papers,
and proposals. As explained herein,
these forms are intended to eliminate
cost and delay associated with the
submission and review of documents
received via non-electronic means and
to improve tracking and records
keeping. The Department is committed
to improving its BAA processes and
invites interested persons to comment
on the following forms and instructions
(hereinafter ‘‘Forms Package’’) for the

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rwilkins on PROD1PC63 with NOTICES

Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices
(BAA) program: (1) DHS Science and
Technology (S&T) BAA Web Site
Registration (DHS FORM 10025), (2)
DHS S&T BAA Registration (DHS FORM
10027), (3) DHS S&T BAA White Paper
and Proposal Submission (DHS FORM
10026), and (4) DHS S&T RFI Response
(DHS FORM 10028). This notice and
request for comments is required by the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13, 44 U.S.C. chapter 35).
DATES: Comments are encouraged and
will be accepted until November 30,
2007. This process is conducted in
accordance with 5 CFR 1320.10.
ADDRESSES: You may submit comments,
identified by docket number [DHS–
2007–0072], by one of the following
methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: [email protected]. Include
docket number [DHS–2007–0072] in the
subject line of the message.
• Mail: Science and Technology
Directorate, ATTN: OCIO/Kenneth D.
Rogers, 245 Murray Drive, Bldg 410,
Washington, DC 20528.
FOR FURTHER INFORMATION CONTACT:
Kenneth D. Rogers (202) 254–6185 (this
is not a toll free number).
SUPPLEMENTARY INFORMATION: This
request for comment was previously
published in the Federal Register on
August 17, 2007, for a 60-day public
comment period ending October 16,
2007. No comments were received by
DHS during the 60-day comment period.
The purpose of this notice is to allow an
additional 30 days for public comments.
This notice and request for comments is
required by the Paperwork Reduction
Act of 1995 (Pub. L. 104–13, 44 U.S.C.
chapter 35).
DHS invites the general public to
comment on the new information
collection forms, as described below.
Interested parties can obtain copies of
the Forms Package by calling or writing
the point of contact listed above.
The DHS S&T Directorate issues RFIs
in accordance with Federal Acquisition
Regulation (FAR) 15.201(e) and accepts
responses to those RFIs from the public.
DHS S&T also issues BAAs in
accordance with FAR 6.102(d)(2)(i) and
FAR 35.016 and accepts white papers
and proposals from the public in
response to those BAAs. DHS S&T
evaluates white papers and proposals
received from the public in response to
a DHS S&T BAA using the evaluation
criteria specified in the BAA through a
peer or scientific review process in
accordance with FAR 35.016(d). White
paper evaluation determines those
research ideas that merit submission of

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a full proposal and proposal evaluation
determines those proposals that merit
selection for contract award.
Unclassified white papers and
proposals are typically collected via the
DHS S&T BAA secure Web site, while
classified white papers and proposals
must be submitted via proper classified
courier or classified mailing procedures
as described in the National Security
Program Operating Manual (NISPOM).
DHS is particularly interested in
comments that:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Suggest ways to enhance the
quality, utility, and clarity of the
information to be collected; and
(4) Suggest ways to minimize the
burden of the data collection on those
who respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submissions of responses.
Overview of this Information
Collection:
(1) Type of Information Collection:
New information collection.
(2) Title of the Form/Collection: DHS
S&T BAA Web Site Registration Form;
DHS S&T BAA Registration Form; DHS
S&T BAA White Paper and Proposal
Submission Form; DHS S&T RFI
Response Form.
(3) Agency Form Number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: DHS Science
and Technology (S&T) BAA Web Site
Registration Form (DHS FORM 10025),
DHS S&T BAA Registration Form (DHS
FORM 10027), DHS S&T BAA White
Paper and Proposal Submission Form
(DHS FORM 10026), and DHS S&T RFI
Response Form (DHS FORM 10028).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Individuals or households,
Business or other for-profit, Not-forprofit institutions, Federal government,
and State, local, or tribal government;
the data gathered through the BAA
Forms Package will be used to collect
RFI responses and unclassified white
papers and proposals through the BAA
Web site.
(5) An estimate of the total number of
respondents and the amount of time

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estimated for an average respondent to
respond: a. An estimate of the total
number of respondents: 4865
Respondents. b. Amount of time
estimated for an average respondent to
respond: 1.25 burden hours.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 1,548.75 burden hours.
Dated: October 18, 2007.
Kenneth D. Rogers,
Chief Information Officer, Science and
Technology Directorate.
[FR Doc. E7–21361 Filed 10–30–07; 8:45 am]
BILLING CODE 4410–10–P

DEPARTMENT OF THE INTERIOR
Office of the Secretary
Exxon Valdez Oil Spill Trustee Council;
Notice of Meeting
Office of the Secretary,
Department of the Interior.

AGENCY:
ACTION:

Notice of meeting.

SUMMARY: The Department of the
Interior, Office of the Secretary is
announcing a public meeting of the
Exxon Valdez Oil Spill Public Advisory
Committee.
DATES:

December 6, 2007, at 9 a.m.

Exxon Valdez Oil Spill
Trustee Council Office, 441 West 5th
Avenue, Suite 500, Anchorage, Alaska.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Douglas Mutter, Department of the
Interior, Office of Environmental Policy
and Compliance, 1689 ‘‘C’’ Street, Suite
119, Anchorage, Alaska 99501, (907)
271–5011.

The
Public Advisory Committee was created
by Paragraph V.A.4 of the Memorandum
of Agreement and Consent Decree
entered into by the United States of
America and the State of Alaska on
August 27, 1991, and approved by the
United States District Court for the
District of Alaska in settlement of
United States of America v. State of
Alaska, Civil Action No. A91–081 CV.
The meeting agenda will include review
of the draft update to the Injured
Resources and Service list and a
discussion about recovery objectives
and environmental monitoring.
SUPPLEMENTARY INFORMATION:

Willie R. Taylor,
Director, Office of Environmental Policy and
Compliance.
[FR Doc. E7–21406 Filed 10–30–07; 8:45 am]
BILLING CODE 4310–RG–P

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