[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55463-55464]
[FR Doc No: 2023-17460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0745]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biologics License
Applications Procedures and Requirements; Voluntary Consensus Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 14, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0338. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Biologics License Applications (BLAs) Procedures and Requirements

OMB Control Number 0910-0338--Revision

    This information collection helps support FDA implementation of
statutory and regulatory requirements that govern biologics product
licensing. We have issued regulations in 21 CFR parts 600-680 setting
forth applicable standards and procedures that include associated
reporting, recordkeeping, and disclosure requirements. Respondents to
the information collection are persons or entities who engage in
manufacture of biologics products. We provide information on our
website at https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber
regarding BLAs, including available Agency resources.
    We are revising the information collection to support
implementation of a standards recognition program for regenerative
medicine therapies at FDA's Center for Biologics Evaluation and
Research (CBER) designed to identify and recognize Voluntary Consensus
Standards (VCS) to facilitate the development and assessment of
regenerative medicine therapy (RMT) products regulated by CBER when
such standards are appropriate. The draft guidance for industry
entitled ``Voluntary Consensus Standards Recognition Program for
Regenerative Medicine Therapies'' (June 2022) describes procedures CBER
will follow when a request for recognition of a VCS is received. The
draft guidance also explains that any interested party may request
recognition of a VCS. The draft guidance document is available for
download at https://www.fda.gov/media/159237/download. We issued the
guidance document consistent with our Good Guidance Practice
regulations in 21 CFR 10.115, which provide for public comment at any
time. We intend on finalizing the guidance document upon OMB approval
of the attendant information collection.
    The use of recognized VCS can assist stakeholders in more
efficiently meeting regulatory requirements and increasing regulatory
predictability for RMT products. We will use requests for recognition
to help identify appropriate VCS that facilitate the development and
assessment of RMT products. We encourage sponsors to use FDA-recognized
VCS in submissions, as conformity to relevant standards helps
streamline regulatory review, foster quality, and may facilitate a
manufacturer's preparation of submissions. As explained in Section V of
the draft guidance document, any stakeholder can request recognition of
a specific VCS.
    In the Federal Register of June 16, 2022 (87 FR 36327), we
published a 60-day notice announcing the availability of the draft
guidance and invited public comment on the proposed collection of
information. We received comment letters supportive of our use of
voluntary consensus standards for regenerative medicine therapies.
Comments encouraged broad application of a voluntary consensus program.
No comments were received regarding the request for recognition
information collection provisions and FDA's need for the information;
the accuracy of our burden estimate; ways to enhance the quality,
utility, and clarity of the information to be collected in the
requests; or ways to minimize burden of the requests. Comments are
being considered as the guidance is finalized.
    Description of Respondents: Respondents to this collection of
information are product sponsors, applicants and other stakeholders
interested in the development of RMT products regulated in CBER.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
 Voluntary consensus standards recognition program for regenerative     Number of      responses per     Total annual    Average burden    Total hours
             medicine therapies; guidance for industry                 respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for recognition of a voluntary consensus standard and                     9                1                9                3               27
 submission of information as specified in Section V...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on our experience with similar information
collection activities. We note that standards development can be a
lengthy process and provide an estimate we believe reflects the amount
of time necessary to prepare and submit the information as discussed in
Section V of the guidance document.

    Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17460 Filed 8-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Proposed Rules]
[Pages 59701-59703]
[FR Doc No: 2014-23650]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0834]
RIN 1625-AA00

Safety Zone, Chesapeake Bay; Cape Charles, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a safety zone on the
navigable waters of the Chesapeake Bay in the vicinity of Bayshore Road
in the Cape Charles Harbor, Cape Charles, VA. This proposed safety zone
would restrict vessel movement in the specified area during the Town of
Cape Charles New Years Eve fireworks display between 10 p.m. and 10:30
p.m. on December 31, 2014. This action is necessary to provide for the
safety of life and property on the surrounding navigable waters during
the fireworks displays.

DATES: Comments and related material must be received by the Coast
Guard on or before November 3, 2014.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT:  If you have questions on this rule,
call or email LCDR Gregory Knoll, Waterways Management Division Chief,
Sector Hampton Roads, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to www.regulations.gov, type the
docket number [USCG-2014-0834] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number [USCG-2014-0834] in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. However, you may
submit a request for one at least 15 days prior to the end of the
comment period specified in DATES, using one of the methods specified
under ADDRESSES. Please explain why you believe a public meeting would
be beneficial. If we determine that a public meeting would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory History and Information

    The town of Cape Charles has not held a fireworks show for the New
Year in the past. This same location is used for other fireworks
displays during the year that are already in 33 CFR 165.506.

C. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    Spectator vessels may gather nearby to view the fireworks display.
Due to the need for vessel control during the fireworks display, vessel
traffic will be temporarily restricted to provide for the

safety of participants, spectators and transiting vessels. Under
provisions of 33 CFR 165.506, during the enforcement period, vessels
may not enter the regulated area unless they receive permission from
the Coast Guard Patrol Commander.

D. Discussion of the Proposed Rule

    The Captain of the Port of Hampton Roads proposes to establish a
safety zone on specified waters of the Chesapeake Bay within a 700 foot
radius of the position: 37[deg]-15'-47'' N / 076[deg]-01'-29'' W (NAD
1983), in the vicinity of Bayshore Road in the Cape Charles Harbor,
Cape Charles, Virginia. This safety zone will be enforced on December
31, 2014 between the hours of 10 p.m. and 10:30 p.m. Access to the
safety zone will be restricted during the specified date and time.
    Except for vessels authorized by the Captain of the Port or his
Representative, no person or vessel may enter or remain in the safety
zone during the time frame listed. The Captain of the Port will give
notice of the enforcement of the safety zone by all appropriate means
to provide the widest dissemination of notice among the affected
segments of the public. This will include publication in the Local
Notice to Mariners and Marine Information Broadcasts.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes and executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The primary impact of
these regulations will be on vessels wishing to transit the affected
waterways during the safety zone on the Chesapeake Bay in the vicinity
of Bayshore Road in the Cape Charles Harbor, Cape Charles, VA from 10
p.m. until 10:30 p.m. on December 31, 2014. Although these regulations
prevent traffic from transiting a portion of the Chesapeake Bay during
this event, that restriction is limited in duration, affects only a
limited area, and will be well publicized to allow mariners to make
alternative plans for transiting the affected area.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    This proposed rule will affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in waters of the Chesapeake Bay during
the outlined timeframe.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (i) The
safety zone will only be in place for a limited duration, and (ii)
before the enforcement period, maritime advisories will be issued
allowing mariners to adjust their plans accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule will not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically

significant rule and does not create an environmental risk to health or
risk to safety that may disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This proposed rule involves the establishment of a
safety zone. This proposed rule is categorically excluded from further
review under paragraph 34-g of Figure 2-1 of the Commandant
Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

 List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T05-0834 to read as follows:

Sec.  165.T05-0834  Safety Zone, Chesapeake Bay; Cape Charles, VA.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector Hampton Roads.
    Representative means any Coast Guard commissioned, warrant or petty
officer who has been authorized to act on the behalf of the Captain of
the Port
    (b) Location. The following area is a proposed safety zone:
Specified waters of the Captain of the Port Sector Hampton Roads zone,
as defined in 33 CFR 3.25-10, in the Chesapeake Bay in the vicinity of
Bayshore Road in the Cape Charles Bay, Cape Charles, VA all waters
within a 700 foot radius of 37[deg]-15'-47'' N/076[deg]-01'-29'' W (NAD
1983).
    (c) Regulations.
    (1) In accordance with the general regulations in 165.23 of this
part, entry into this zone is prohibited unless authorized by the
Captain of the Port, Hampton Roads or his designated representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Contact on scene contracting vessels via VHF channel 13 and 16
for passage instructions.
    (ii) If on scene proceed as directed by any commissioned, warrant
or petty officer on shore or on board a vessel that is displaying a
U.S. Coast Guard Ensign.
    (3) The Captain of the Port, Hampton Roads can be reached through
the Sector Duty Officer at Sector Hampton Roads in Portsmouth, Virginia
at telephone number<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM marine band radio channel 13 (165.65Mhz) and
channel 16 (156.8 Mhz).
    (d) Enforcement Period: This section will be enforced from 10 p.m.
until 10:30 p.m. on December 31, 2014.

    Dated: September 16, 2014.
Christopher S. Keane,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2014-23650 Filed 10-2-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 107 (Monday, June 4, 2012)]
[Rules and Regulations]
[Pages 32897-32898]
[FR Doc No: 2012-13409]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Novopharm
Ltd. to Teva Canada Ltd.

DATES: This rule is effective June 4, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novopharm Ltd., 30 Novopharm Ct., Toronto,
Ontario, Canada M1B 2K9 has informed FDA of a change of name to Teva
Canada Ltd. Accordingly, the Agency is amending the regulations in 21
CFR 510.600(c) to reflect these changes.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is
amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Novopharm Ltd.'' and alphabetically add a new entry for ``Teva
Canada Ltd.''; and in the table in paragraph (c)(2), revise the entry
for ``043806'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------

                                * * * * *
Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada      043806
 M1B 2K9.....................................................

                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
             Drug labeler code                 Firm name and  address
------------------------------------------------------------------------

                                * * * * *
043806....................................  Teva Canada Ltd., 30
                                             Novopharm Ct., Toronto,
                                             Ontario, Canada M1B 2K9.

                                * * * * *
------------------------------------------------------------------------

    Dated: May 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13409 Filed 6-1-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 11, 2007 (Volume 72, Number 69)]
[Notices]
[Page 18237-18238]
[DOCID:fr11ap07-79]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0954; FRL-8122-6]

Dikegulac Sodium Reregistration Eligibility Decision; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:  This notice announces the availability of EPA's
Reregistration Eligibility Decision (RED) for the pesticide dikegulac
sodium, and opens a public comment period on this document. The
Agency's risk assessments and other related documents also are
available in the dikegulac sodium Docket. Dikegulac sodium is a plant
growth regulator used in greenhouses, nurseries, and on landscape
trees, ornamentals, and plants. EPA has reviewed dikegulac sodium
through a modified low risk version of the Agency's public
participation process with a public comment period following the
publication of the RED. Through this process, EPA is ensuring that all
pesticides meet current health and safety standards.

DATES:  Comments must be received on or before June 11, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0954, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0954. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either in the
electronic docket at http://www.regulations.gov, or, if only available

in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Jacqueline Guerry, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.

    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, dikegulac sodium, under section 4(g)(2)(A) of FIFRA.
Dikegulac sodium is a plant growth regulator used in greenhouses,
nurseries, and on landscape trees, ornamentals, and plants. Dikegulac
sodium is applied either as a foliar spray or by pressure injection.
Landscape use sites include parks, school campuses, city streets, and
similar recreational, institutional, or industrial areas. EPA has
determined that the data base to support reregistration is
substantially complete and that products containing dikegulac sodium
are eligible for reregistration, provided that the risk mitigation
measures outlined in the RED document are adopted, and label amendments
are made to reflect these measures. Upon submission of any required
product specific data under section 4(g)(2)(B) and any necessary
changes to the registration and labeling (either to address concerns
identified in the RED or as a result of product specific data), EPA
will make a final reregistration decision under section 4(g)(2)(C) for
products containing dikegulac sodium.
     EPA is applying the principles of public participation to all
pesticides undergoing reregistration. The Agency's Pesticide Tolerance
Reassessment and Reregistration; Public Participation Process,
published in the Federal Register on May 14, 2004, (69 FR 26819)(FRL-
7357-9) explains that in conducting these programs, EPA is tailoring
its public participation process to be commensurate with the level of
risk, extent of use, complexity of issues, and degree of public concern
associated with each pesticide. Due to its low volume/minor uses, low
human health and ecological risks, and other factors, the low risk
pesticide dikegulac sodium was reviewed through a modified version of
the Agency's public participation process.
    The reregistration program is being conducted under Congressionally
mandated time frames, and EPA recognizes the need both to make timely
decisions and to involve the public. The Agency is issuing the
dikegulac sodium RED for public comment. This comment period is
intended to provide an opportunity for public input and a mechanism for
initiating any necessary amendments to the RED. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
Agency Docket for dikegulac sodium. Comments received after the close
of the comment period will be marked ``late.'' EPA is not required to
consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the
document, EPA also will publish an amendment to the RED in the Federal
Register. In the absence of substantive comments requiring changes, the
dikegulac sodium RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, the Administrator
shall determine whether pesticides containing such active ingredient
are eligible for reregistration, before calling in product specific
data on individual end-use products and either reregistering products
or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 2, 2007.
 Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-6627 Filed 4-10-07; 8:45 am]

BILLING CODE 6560-50-S


see if a similar finding will be forthcoming in that study.
[Slide]
In conclusion, we don't really know what these
agents mean.  Despite the fact that we found these cases, I
don't really think this was the cause of their hepatitis.
I think it is somehow an artifact of our selection process,
but it is very hard to rule that out.  We are going to
discover molecular agents.  The sensitivity of our
techniques is so high now that we will continue to discover
new agents, and there are three possibilities for these new
agents.
One is that they are not pathogenic; that these
really represent commensal agents or, if you will, a normal
viral flora.  Perhaps these agents have other purposes.
Perhaps they are there for evolutionary purposes.  So, that
is one possibility.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
Secondly, it is possible that most members of
these families are benign; that there may be some variants
that cause disease of the liver, as perhaps in DNH, but
also of other organs.  There are many unexplained diseases.
Are these an agent of some unexplained disease?  There is
no evidence for that as yet.  But it is difficult to study
this because the prevalence is so high.  You have to find
this enormously high association with a disease to work on
causality.
Lastly, they may cause disease only in persons
who are uniquely susceptible, either genetically
susceptible or by immune deficiency or by some other
susceptibility factor.  Thus far there is no evidence for
this and they don't appear to cause more disease in
patients, like HIV-infected patients.  But it is very
difficult to prove any one of these three hypothesis.
[Slide]
But we are working on it and, as a government
worker, I want you to know that I give a hundred percent
effort to whatever I do.
[Laughter]
We have distributed funding and today happens to
be a 23 percent day so you are getting a pretty good
effort.  Thank you very much.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
DR. EPSTEIN:  Harvey, thank you.  That was both
informative and entertaining.  Again, one or two questions.
Steve?
DR. KLEINMAN:  Steve Kleinman.  Harvey, I know
some years ago you reported CMV hepatitis in your patients.
You know, maybe that is an analogy for SENV where it is a
virus that really doesn't cause hepatitis in most people
and, if it does, it can just cause mild hepatitis and, in
fact, you don't see any chronic sequelae because it is a
rare event and it is really clinically not a very
significant event.
DR. ALTER:  Yes.  When I grew up, that was a $64
dollar question; now it is a 64 million dollar question.
It is hard to rule out the possibility that it only causes
disease in an occasional patient or even that it causes
diseases that we are not looking for right now.  There is
no evidence now that we should be testing.  But the counter
argument is always, "well, what if?"  What if it might do
something.
DR. KLEINMAN:  But not even going there, just to
the extent that you have a clinical finding that you need
to explain and you can explain it as an unusual
manifestation of this viral infection that isn't very
clinically significant.  I mean, that is why you get CMV

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
hepatitis; it happens but nobody really thinks of CMV as
being a hepatitis agent.
DR. ALTER:  Well, you do know that hepatitis is
part of the CMV story and in some people it can
predominate.  So, there is a little difference but I can't
rule it out.  That is why we have been reluctant to give up
on these viruses, because there may be something there.
They could be a very interesting class of viruses, and why
do we have all these viruses in our body?  That is what
intrigues me.
DR. EPSTEIN:  I don't think we should give up on
viruses that haven't given up on us.  Any other questions?
No?  Thank you again.  We are going to move on to our next
set of speakers on the topic of regulatory issues and
perspectives, and Dr. Paul Mied will first talk about the
FDA agenda on implementation of NAT for hepatitis C and
HIV.  Paul?
I.  Regulatory Issues and Perspectives
US FDA: Implementation of NAT for HCV and HIV
DR. MIED:  Thank you, Dr. Epstein.
[Slide]
This morning I would like to briefly outline for
you FDA's current thinking on implementation of NAT on
pooled source plasma and whole blood samples, HIV RNA and
HCV RNA.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
By way of background, let me discuss some FDA
perspectives that were summarized, the recent history and
the current regulatory status of pooled sample NAT.  Back
in September of 1994, we held a workshop to discuss the
potential application of nucleic acid based methods to the
screening of blood and plasma donations for HIV.  It was
felt at that time that although these methods were clearly
sensitive, they were not ready for implementation on a
large scale.  But the industry actively pursued the
development of NAT for screening blood and plasma donors.
Due to the cost and labor intensiveness of NAT, there was
much interest in testing pools of plasma samples, or
minipools by NAT.
By 1997, some manufacturers in Europe had
voluntarily instituted NAT on minipools.  About that time,
the European Union issued a directive, and this directive
stated that by July 1, 1999 HCV RNA testing would be
required in Europe for all plasma for fractionation, and
that the requirement for HIV-1 RNA testing would follow at
a later date.  In the United States NAT or minipools were
first introduced as an in-process control test for plasma
for fractionation.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
However, the European directive and our own
position at that time that pooled sample testing by NAT for
HIV or HCV constituted a form of donor screening provided
impetus for the rapid development of NAT for all blood and
plasma donations.  We have taken the position that NAT
tests used to screen blood and plasma for HIV RNA and HCV
RNA are subject to regulation as biological products under
the licensing mechanism.
NAT screening of blood and plasma donations was
expected to improve blood safety while not interfering with
current measures of safety.  Therefore, we permitted the
clinical study of this investigational technology on a
large scale under IND.  Such large-scale studies were
necessary to demonstrate the efficacy of NAT in further
reducing the residual risk of infectious disease
transmission primarily because of the low frequency of
window period donations.  Testing of pooled specimens
rather than single donations was identified as a preferred
format due to the technical state of the development of
NAT.  Test kit manufacturers and testing laboratories
submitted INDs describing their test method and validation
at the preclinical level.  Blood organizations and
establishments intending to use the assay for donor
screening also filed INDs to describe their clinical trial
protocol for validation of pooled sample NAT. So, donor

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
screening by NAT for HIV and HCV on pooled specimens was
implemented nationwide under the IND mechanism.
[Slide]
On November 26, 1999 FDA published a draft
guidance for industry application of current statutory
authority to nucleic acid testing of pooled plasma.  In
this guidance document we provided industry with
alternative pathways for regulatory approval of pooled
sample NAT tests for HIV and HCV to screen blood and plasma
donations.
On December 14, 1999 we published a guidance for
industry on the validation of NAT methods to screen plasma
donors in the manufacture and clinical evaluation of in
vitro tests to detect nucleic acid sequences of HIV-1 and
2.  This document provided guidance on manufacturing and
clinical trials to obtain licensure of the test method for
use in donor screening for transfusion-transmitted viruses.
In this document FDA also discussed standards for NAT
methods used to test pooled plasma.
[Slide]
As Dr. Epstein mentioned, on September 18, 2001
FDA licensed the first NAT system.  This is the NGI
UltraQual HIV-1 and HCV RT-PCR assays.  These assays are
performed in-house by NGI.  And, Alpha Therapeutic
Corporation was licensed to use the NGI assays for

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
qualitative testing of pooled samples from donors of source
plasma.  I should mention that data collected by NGI under
IND and submitted in their license application demonstrated
that the licensed NGI HIV NAT method is sufficiently
sensitive to replace p24 antigen screening of pooled
samples of source plasma.
Also as Dr. Epstein mentioned, at the present
time nearly all source plasma and whole blood collected in
the U.S. are tested for HIV-1 RNA and HCV RNA, and this
testing is being done using the licensed NGI pooled sample
NAT method or under an approved IND for pooled sample NAT.
Now that a NAT method has been licensed, I am
going to outline FDA's current thinking on NAT testing,
product management and donor management using a licensed
method for NAT on pooled source plasma or whole blood
samples for HIV RNA and HCV RNA.  FDA intends that these
elements of our current thinking form the basis for a draft
guidance document in the near future that provides
recommendations to blood and plasma establishments,
manufacturers and testing laboratories that are
implementing a licensed NAT method.
At the March, 2001 meeting of the Blood Products
Advisory Committee FDA proposed uniform algorithms for
management of whole blood and source plasma donations
tested by pooled sample NAT and a multiplex test for both

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
HIV RNA and HCV RNA.  If a reactive net result is obtained
for a master pool, it is appropriate to perform subsequent
testing to identify the individual unit that is positive as
the basis for the reactive result on the pool.  The focus
of the FDA proposed algorithms was the action that should
be taken in the event of discrepant testing results, such
as when the master pool was reactive but individual
donations are then found to be non-reactive.
Data generated using NAT under IND showed that in
each discrepant case it was the master pool that was
falsely reactive.  This was due to contamination either
during specimen handling or during the assay run.  False
negatives on individual donations have not been seen in the
studies performed using various NAT methods under IND.
The Blood Products Advisory Committee felt that
in each case in which there was a discrepancy between the
master pool reactive NAT result and the negative NAT
results on individual donations, the negative NAT result on
individual donations should be considered the definitive
test result.  Therefore, units could be released on the
basis of the individual donation test results.
[Slide]
This first algorithm is likely to be used by
establishments testing smaller pools, for example, pools of
16 or 24 samples from whole blood or source plasma

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
donations.  Those establishments would most likely prefer
to directly test all individual donations from which
samples were originally pooled to make the NAT reactive
master pool.
Now, if you are one of those blood
establishments, you should test the individual donations
using the same NAT method -- primers, probes, etc. -- that
was used in the original NAT on the original master pool.
If one or more of those individual donations is reactive
you may release the non-reactive donations provided
serologic tests on those donations are negative.  You
should discard the reactive donation, defer the donor
indefinitely, and test the reactive donation using a
discriminatory NAT.  That is essentially the same NAT test
for the RNA of the individual viruses.
If the discriminatory NAT is positive for HIV RNA
or HCV RNA, you should notify and counsel the donor
regarding the meaning of the test result and the need for
medical referral so that follow-up testing may be
performed.  You should also perform look-back for HIV or
HCV to identify prior donations from that donor made within
a certain time period.  False-positive NAT results have
been known to occur.  Therefore, the donor may be eligible
for reentry depending upon serological test results and
other criteria.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
If the donation is negative for both HIV RNA and
HCV RNA, you should test the donation using an additional
NAT.  That is a NAT that uses an amplification technology
and/or primers that are different from those that were used
in the original NAT on the master pool.  If the additional
NAT is positive, you should defer the donor permanently;
notify or refer the donor for medical follow-up and perform
look-back for HIV or HCV.  If the additional NAT is
negative, you should notify and appropriately counsel the
donor, and that donor may be eligible for reentry.
On the other hand, if all individual donations
are non-reactive, our current thinking is to permit the
release of all donations provided, of course, serologic
tests for HIV and HCV on those donations are negative.
However, as part of an overall quality assurance program,
we encourage you to conduct additional testing to determine
the cause of the initial reactivity of the master pool.
[Slide]
The second alternative algorithm is more likely
to be used by source plasma establishments that prefer to
perform a deconstruction of the master pool that contains a
larger number of donations by testing archived or freshly
pooled subpools to identify the reactive individual
donation.  You should test the archived or freshly made
subpools using the same NAT method -- primers, probes, etc.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
--
that was used in the original NAT on the master pool.
This deconstruction of the master pool to determine the
basis for the reactivity may actually involve several
layers of testing using archived or freshly pooled
subpools.  If one or more of the subpools is reactive, you
may release the donations that comprise the non-reactive
subpools provided, of course, serologic tests on those
donations are negative.
You should test the individual donations that
comprise the reactive subpool using the same NAT method
that was used in the original NAT on the master pool.  If
one or more of the individual donations is reactive, you
may release the non-reactive donations provided, of course,
that serologic tests on those donations are negative.
You should discard the reactive donation; defer
the donor indefinitely; and test the reactive donation
using a discriminatory NAT.  The rest of the algorithm is
the same as the first algorithm that went directly from the
master pool to testing of individual donations.
On the other hand, if all subpools are non-
reactive, our current thinking is to permit the release of
all donations that comprise the non-reactive subpools
provided, of course, that serologic tests for HIV and HCV
on all donations in those subpools are negative.  However,
as before, as part of an overall quality assurance program,

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
we encourage you to conduct additional testing to determine
the cause of the initial reactivity of the master pool.
[Slide]
FDA's current thinking is to include
recommendations for donor reentry into a draft guidance
document on NAT implementation.  We are also considering
using that draft guidance to update the reentry algorithms
for donors deferred because of serologic HIV or HCV test
results since the reentry procedures for those donors
should also integrate both NAT and serology test results.
We are considering recommending that three groups
of donors, deferred because of HIV test results, be
considered for reentry.  The first group consists of donors
who had NAT reactive results but were seronegative, those
we just talked about.  The HIV discriminatory NAT may have
been either positive or negative but if an additional NAT
was performed, a NAT that uses amplification technology
and/or primers that are different from those that were used
in the original NAT method on the master pool, that test
must have been negative.
The second and third groups consist of donors
with negative NAT who have a repeatedly reactive screening
test for HIV antibody and negative or indeterminate HIV-1
Western Blot or IFA results on the index sample, or who
have a repeatedly reactive EIA for HIV-1 p24 antigen with

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
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an indeterminant, that is, an invalid or non-neutralized
result on the neutralization test.
For all three groups of donors deferred because
of HIV NAT or HIV antibody or antigen test results, we are
considering recommending that a follow-up sample be taken
after a minimum time period of eight weeks for follow-up
testing of the donor by both a licensed HIV NAT and a
licensed HIV antibody EIA.
Data that we saw presented at the June, 2001
Blood Products Advisory Committee meeting demonstrated that
an eight-week follow-up period encompasses the pre-
seroconversion window period for HIV with sufficient
confidence that negative serology tests after at least
eight weeks have passed rule out HIV infection.
If you wish to perform follow-up testing on the
donor prior to the end of this eight-week period, you may
do so for donor notification purposes or for medical
reasons.  However, if you again obtain a NAT reactive or
repeatedly reactive antigen or antibody test result during
this eight-week deferral period you should permanently
defer the donor.  You may use negative results on the HIV
tests prior to the end of this eight-week period and donor
counseling, however, only a negative screening test result,
obtained at least eight weeks after the repeatedly reactive

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
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result on the index donation, qualifies as the test of
record for purposes of donor reentry.
I should also add that to alleviate the concern
about the inappropriate entry of a donor infected with HIV-
1 group O or an HIV-1 variant, the testing on the follow-up
sample from the donor should include a licensed HIV NAT
method that is labeled sensitive for HIV-1 group O and HIV
group M variants.
In addition, the anti-HIV-1,2 EIA test performed
on the follow-up sample should be the original EIA test for
HIV-1 and HIV-2 that was run on the index donation, or
there could be an alternate EIA that also an HIV-2 test and
is labeled sensitive for HIV-1 group O.
[Slide]
In the absence of evidence for seroconversion,
that is, if the anti-HIV EIA is negative, a negative NAT on
follow-up testing at least eight weeks later may be taken
as evidence that any previous reactive NAT result on the
index donation that was not confirmed by a reactive result
on additional NAT was, in fact, an error.  If both the NAT
and EIA tests on the follow-up sample are negative, the
donor may be reentered, that is, becomes eligible for
future donation.  A donation taken at a later date would
then be tested using the usual battery of screening tests.
Thus, two NAT tests and two EIA tests would be performed

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
and must be negative before a unit from that donor could be
used.
[Slide]
FDA's current thinking is to also include in the
future draft guidance document a recommendation that two
groups of donors, deferred because of HCV test results, be
considered for reentry.
The first group consists of donors who had a NAT
reactive result but were seronegative, those we already
talked about.  The HIV, HCV discriminatory NAT may have
been either positive or negative, but if an additional NAT
was performed it must have been negative.
The second group of donors consists of donors
with a negative NAT who have repeatedly reactive screening
tests for anti-HCV antibody, with negative or indeterminate
label results on the index sample.
As we have already heard this morning from Dr.
Busch, our current research indicates that detectable
viremia may be intermittent and may also be resolved in
about 20 percent of cases of HCV infection.  For purposes
of NAT possible HCV viremia, optionally you may follow-up
the deferred donor with an HCV NAT and an anti-HCV EIA test
at any time up to six months after the index donation, for
example, eight weeks later.  A reactive HCV NAT or positive
HCV antibody test result would exclude the possibility of

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
reentry for that donor.  If that NAT test is non-reactive
and HCV antibody testing is not positive, the donor should
be follow-up with another HCV NAT and an anti-HCV EIA at
least six months after the index donation to qualify the


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a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. P Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,830 b. Total annual responses 1,830 1. Percentage of these responses collected electronically % c. Total hours requested 915 d. Current OMB inventory 1,348 e. Difference  433 f. Explanation of difference 1. Program Change 2. Adjustment  433 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. G Recordkeeping b. G Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi annually 6. G Annually 7. G Biannually 8. G Other ( describe)

17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff Phone: 202 260 2922 OMB 83 I 10/ 95 RECEIVED OPPT NCIC 2003 July 25 9: 56AM OPPT 2003 0048 0001 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95