"King, Heidi R."<EMAIL_ADDRESS> 02/07/2008 02:29 PM

To

Joseph Pinto/RTP/USEPA/US@EPA

cc

Ila Cote/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA

Subject

RE: Harvard (GEOS-Chem)/Argonne National Lab research on transboundary ozone influences

Delighted!

I don't think Thu or Fri are options for anyone in the interagency group

or for the presenters.

Tuesday 2/12 works for you, but Wed 2/13 is not possible for you?

Your call on whether you call-in or fly up.  I realize this has been an

ongoing discussion, this is apparently new findings to share with the

group.

Thanks --

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, February 07, 2008 2:23 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Fw: Harvard (GEOS-Chem)/Argonne National Lab research on

transboundary ozone influences

Heidi, as you can gather from Ron's message, I've been asked to

represent EPA at this presentation. I'm not sure if you were involved at

the time but Tom Grahame and I have had discussions on this and related

issues last year as part of the interagency review for the ozone

proposal.

The best times for me would be Thursday and Friday, followed by Tuesday.

Were you planning a video conference  or to ask me to fly up to D.C.?

Joseph Pinto, PhD.

U.S. Environmental Protection Agency

Mailing address:   B-243-01, RTP, NC  27711

Physical address: 109 T.W. Alexander Dr., RTP, NC  27709

Courier address:   4930 Page Road, RTP, NC  27709

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

----- Forwarded by Joseph Pinto/RTP/USEPA/US on 02/07/2008 02:11 PM

-----

Ron Evans/RTP/USEPA/US wrote on 02/07/2008 09:59:35 AM:

> Joe, based on a conversation with am with Lydia and Karen, it would

> probably be best if you could reach out to Heidi King to work on

> arrangements for this presentation.   Given the science nature of

> the presentation, we would appreciate it if you and others in ORD

> represented EPA in this presentation.  The thought would be that you

> could then come back to those of us in OAQPS with your take on the

> science.   I think that Tyler Fox would also be comfortable with

> this approach but please check with him as well.  Thanks.

>

> Ron Evans

> Leader, Air Benefit & Cost Group

> HEID/OAQPS/OAR/EPA

> Mail Drop C-439-02

><PHONE_NUMBER>

><PHONE_NUMBER> fax


[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62222-62224]
[FR Doc No: 2021-24413]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93513; File No. SR-BX-2021-051]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
of Proposed Rule Change To Amend Exchange Rules in Connection With the
Proposed Merger of BX Equities LLC With and Into the Exchange

November 3, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 22, 2021, Nasdaq BX, Inc. (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules in connection with the
proposed merger of BX Equities LLC (``BX Equities'') with and into the
Exchange (the ``Merger''). As a result of the Merger, BX Equities will
be eliminated, and the Exchange will directly operate its equities and
options markets.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its rules in connection with the
proposed Merger of BX Equities with and into the Exchange. The Exchange
notes that the proposed Merger is the second part of a two-step
process, the first part of which is the transfer of Nasdaq, Inc.'s
(``Nasdaq HoldCo'') entire ownership interest in BX Equities to the
Exchange, which will result in the Exchange becoming the 100% direct
owner and sole LLC member of BX Equities (the ``Transfer'' and together
with the Merger, the ``Transactions'').\3\ The Transactions will
ultimately result in the elimination of BX Equities. The Transactions
are designed to simplify the corporate structure of the Exchange's sole
stockholder Nasdaq HoldCo and Nasdaq HoldCo's subsidiaries,
specifically the Exchange and BX Equities. The Transactions will not
have any effect on Nasdaq HoldCo's direct ownership of the Exchange.
---------------------------------------------------------------------------

    \3\ The proposed Transfer is the subject of a separate rule
filing to be filed by the Exchange with the Commission concurrent
with this filing. Specifically, the Transfer filing would amend the
BX Equities Operating Agreement to reflect Nasdaq HoldCo's transfer
of ownership interest in BX Equities to the Exchange. The Merger
filing would then delete the BX Equities Operating Agreement that
was amended in the Transfer filing and delete the Delegation
Agreement to reflect the Merger. See SR-BX-2021-050 (not yet
published).
---------------------------------------------------------------------------

    By way of background, BX Equities was established in 2008 as a
facility of and controlled subsidiary owned and operated by the
Exchange for the listing and trading of cash equity securities.\4\ BX
Equities is currently governed by a Delegation Agreement between the
Exchange and BX Equities (``Delegation Agreement''), under which the
Exchange has delegated certain responsibilities to BX Equities to
operate the Exchange's equities market.\5\ BX Equities is also
currently governed by the Fifth Amended and Restated Operating
Agreement (``Operating Agreement''). As noted above, the Exchange is
concurrently submitting a separate filing that amends the Operating
Agreement to reflect the Transfer, which will result in the

Exchange becoming the sole owner and LLC member of BX Equities.\6\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 59154 (December 23,
2008), 73 FR 80468 (December 31, 2008) (SR-BSE-2008-48) (``BX
Equities Approval Order''). The NASDAQ OMX Group, Inc. (as
referenced in the BX Equities Approval Order) is now Nasdaq, Inc.
    \5\ The Exchange also directly operates an options market.
    \6\ See supra note 3.
---------------------------------------------------------------------------

    Following the Merger, the Exchange will be the surviving entity,
and it will directly operate both the Exchange's equities and options
markets. The Exchange is proposing amendments in order to reflect those
changes.
    Specifically, the proposed amendments would ultimately allow the
Exchange to directly operate both markets by:
     Terminating the existing delegation to BX Equities;
     removing the BX Equities Operating Agreement; and
     amending the Exchange's rules to eliminate all references
to the Delegation Agreement, BX Equities Operating Agreement, and BX
Equities LLC.
    Each item will be discussed in detail below. The Exchange intends
to implement the Transactions (including the proposed changes in this
filing to reflect the Merger) by the end of Q4 2021. The Exchange
anticipates that the Merger will occur immediately after the Transfer.
Termination of Delegation
    The Delegation Agreement was executed in 2008 following the
establishment of BX Equities as a cash equities trading facility of the
Exchange. The delegation is limited to the Exchange's equities market
functions and does not include other functions not specifically
mentioned in the limited delegation. However, the Exchange retains
ultimate responsibility for its equities market, including the
responsibility to ensure the fulfillment of statutory and self-
regulatory obligations under the Act.\7\
---------------------------------------------------------------------------

    \7\ See Delegation Agreement (providing that the Exchange shall
have ultimate responsibility for the operations, rules and
regulations developed by BX Equities, as well as their enforcement,
and that actions taken by BX Equities pursuant to delegated
authority remain subject to review, approval or rejection by the
Exchange's Board in accordance with the procedures established by
the Board). See also BX Equities Approval Order at 80470.
---------------------------------------------------------------------------

    In connection with the proposed Merger, the Exchange now proposes
to terminate the delegation of functions to BX Equities set forth in
the Delegation Agreement, and remove the Delegation Agreement from its
rules. With the termination of the Delegation Agreement, all of the
functions that were previously delegated to BX Equities will now be
performed by the Exchange as the Exchange will directly operate its
equities market upon the elimination of BX Equities. Furthermore, the
Exchange will continue to bear responsibility over its equities market
of ensuring the fulfillment of its statutory and self-regulatory
obligations.
Removal of Operating Agreement
    As discussed above, the Exchange is concurrently proposing
amendments to the Operating Agreement to reflect that the Exchange will
be the only owner and sole LLC member of BX Equities. In addition,
management of BX Equities is vested solely in the Exchange.\8\ As
stated in the BX Equities Approval Order, having the managerial powers
vested solely in the Exchange is designed to preserve the Exchange's
regulatory authority over BX Equities, and grants the Exchange the
ability to direct BX Equities to perform any required, necessary, or
appropriate act.\9\ By virtue of BX Equities' structure as a facility
of the Exchange, and the Exchange's exclusive management rights, BX
Equities is bound by all of the regulatory obligations of its SRO-
member. For instance, the Exchange's independent regulatory oversight
committee (``ROC'') currently oversees the regulatory program of the
Exchange and its facilities, and meets regularly with the Exchange's
Chief Regulatory Officer (``CRO'').\10\ In addition, the Exchange'
independent regulatory department under the oversight of the ROC
carries out the Exchange's regulatory functions, including
administering its membership and disciplinary rules, and performing
real-time surveillance over participants in the Exchange's equities and
options market. Ultimately, BX Equities can only act through the action
of the Exchange and its officers and directors by virtue of the fact
that there is no separate BX Equities board of directors and all BX
Equities officers are officers of the Exchange.\11\
---------------------------------------------------------------------------

    \8\ See Section 4.1, Operating Agreement (stating that as sole
manager of BX Equities, the Exchange shall have the power to do any
and all acts necessary, convenient or incidental to or for the
furtherance of the purposes described in the Operating Agreement,
and that the Exchange has the authority to bind BX Equities).
    \9\ See BX Equities Approval Order at 80470.
    \10\ See Section 4.13(c) of the Exchange's By-Laws. BX Equities
does not have a separate ROC.
    \11\ See supra note 7 [sic]. See also Section 5.1, Operating
Agreement (stating that officers of BX Equities must also be
officers of the Exchange).
---------------------------------------------------------------------------

    With the termination of the Delegation Agreement proposed above, BX
Equities would no longer be operating the Exchange's equities market
and as a result, the Operating Agreement will become obsolete.
Accordingly, the Exchange proposes to remove the Operating Agreement
from its rules.
Exchange Rule Amendments
    The Exchange proposes to make certain conforming amendments to its
rules to reflect the proposed Merger of BX Equities into the Exchange
and the resulting deletion of the Delegation Agreement and Operating
Agreement. In particular, the Exchange proposes to make the following
conforming amendments:
     General 2, Section 8 currently references the Delegation
Agreement, and states that the staff, books, records and premises of BX
Equities LLC are the staff, books, records and premises of the Exchange
subject to oversight pursuant to the Act, and all officers, employees
and agents of BX Equities LLC are the officers, employees and agents of
the Exchange for purposes of the Act. The Exchange now proposes to
delete the rule text and reserve the rule.
     Equity 1, Section 1 currently includes the definitions of
Delegation Agreement (Equity 1, Section 1(a)(2)) and BX Equities
(Equity 1, Section 1(a)(5)). The Exchange now proposes to delete these
definitions and reserve the respective rules.
     In Equity 1, Section 1(a)(3), the Exchange proposes to
delete the references to the Delegation Agreement and Operating
Agreement.
     In Equity 1, Section 1(a)(6), the Exchange proposes to
delete ``through BX Equities LLC as a facility of the Exchange'' from
the first sentence.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of Section
6(b)(1) of the Act,\13\ in particular, in that it enables the Exchange
to be so organized as to have the capacity to be able to carry out the
purposes of the Exchange Act and to comply, and to enforce compliance
by its exchange members and persons associated with its exchange
members, with the provisions of the Exchange Act, the rules and
regulations thereunder, and the rules of the Exchange.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(1).
---------------------------------------------------------------------------

    Specifically, termination of the Delegation Agreement would result
in the Exchange directly operating the equities market facility of the
Exchange. With the termination of the Delegation Agreement, all of the
functions that were previously delegated to BX Equities will now be
performed by the Exchange as the Exchange will directly operate its
equities market upon the elimination of BX Equities. Furthermore, the
Exchange will continue to bear responsibility over its

equities market of ensuring the fulfillment of its statutory and self-
regulatory obligations. As stated above, the independent ROC of the
Exchange's Board would continue to oversee the Exchange's regulatory
and self-regulatory organization responsibilities with regards to both
the equities and options markets, and the Exchange's regulatory
department would continue to carry out its regulatory functions with
respect to both markets under the oversight of the ROC.\14\ For the
same reasons, the Exchange believes that its proposal to remove BX
Equities' Operating Agreement from the Exchange's rules in connection
with the proposed termination of the Delegation Agreement is also
consistent with Section 6(b)(1) of the Act.
---------------------------------------------------------------------------

    \14\ See supra note 9 [sic].
---------------------------------------------------------------------------

    The Exchange also believes that this filing furthers the objectives
of Section 6(b)(5) of the Act,\15\ in particular, in that it is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest. The Exchange believes that the deletion of the
Delegation Agreement and Operating Agreement from the Exchange's rules,
and related conforming Exchange rule amendments, each as discussed
above, is consistent with Section 6(b)(5) of the Act because the
proposed changes would add clarity and transparency to the Exchange's
Rulebook, ensuring that persons subject to the Exchange's jurisdiction,
regulators, and the investing public can more easily navigate and
understand the Exchange's rules.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change is not
designed to address any competitive issues but rather is concerned
solely with the corporate structure of the Exchange and the
administration and function of its corporate governance structures.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BX-2021-051 on the subject line.

Paper Comments

     Send paper comments in triplicate to: Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File Number SR-BX-2021-051. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2021-051 and should be submitted on
or before November 30, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-24413 Filed 11-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Page 2218]
[FR Doc No: 2019-01146]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-250]

Alabama Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 2146-250.
    c. Date Filed: December 14, 2018.
    d. Applicant: Alabama Power Company.
    e. Name of Project: Coosa Hydroelectric Project.
    f. Location: Logan Martin Lake on the Coosa River in Talladega
County, Alabama.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Justin Bearden, Shoreline Management, Alabama
Power Company, 600 North 18th Street, Birmingham, Alabama 35203, (205)
257-6769<EMAIL_ADDRESS>    i. FERC Contact: Mark Carter,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: March 1, 2019.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-2146-250. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Alabama Power Company proposes to permit
the construction of Logan Martin RV Park within the project boundary.
Logan Martin RV Park owns, whereas Alabama Power holds flood rights
over, the land that would be permitted. The RV Park would include 16
fixed boat docks (measuring 13,980 square feet total, and to
accommodate 174 boats at a time), 1 boat ramp (measuring 20 feet wide
by 150 feet long), 1 road, and 119 RV pads (with associated wooden
decks, concrete patios, and parking areas) within the project boundary.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: January 30, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-01146 Filed 2-5-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Rules and Regulations]
[Pages 40512-40518]
[FR Doc No: 2016-14721]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-N-1484]

Revisions to Exceptions Applicable to Certain Human Cells,
Tissues, and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
issuing this final rule to amend certain regulations regarding donor
eligibility, including the screening and testing of donors of
particular human cells, tissues, and cellular and tissue-based products
(HCT/Ps), and related labeling. This final rule is in response to our
enhanced understanding in this area and in response to comments from
stakeholders regarding the importance of embryos to individuals and
couples seeking access to donated embryos.

DATES: This rule is effective August 22, 2016.

ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response

    C. Purpose and Scope of the Final Rule (Sec.  1271.1)
    D. Donor Screening (Sec.  1271.75)
    E. Exceptions From the Requirement of Determining Donor
Eligibility (Sec.  1271.90)
    F. Labeling Requirements (Sec.  1271.370)
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to amend certain regulations
regarding donor eligibility, including the screening and testing of
donors of particular HCT/Ps, and related labeling. We are finalizing
these changes in response to our enhanced understanding in this area
and in response to comments from stakeholders regarding the importance
of embryos to individuals and couples seeking access to donated
embryos.

B. Summary of the Major Provisions of the Final Rule

    FDA is amending existing regulations to provide additional
flexibility to HCT/P establishments to make available for reproductive
use embryos originally intended for reproductive use for a specific
individual or couple when those embryos are subsequently intended for
directed or anonymous donation. Specifically, this rulemaking
redesignates the current Title 21 of the Code of Federal Regulations
(CFR) 1271.90(b) (Sec.  1271.90(b)) to new Sec.  1271.90(c), and would
insert a new Sec.  1271.90(b) entitled ``Exceptions for reproductive
use'' to clarify that if an embryo was originally intended for
reproductive use for a specific individual or couple, its use for
directed or anonymous donation, would not be prohibited under Sec.
1271.45(c), even when the applicable donor eligibility requirements
under part 1271, subpart C, are not met. FDA also clarifies that we are
not creating an exception for deficiencies that occurred in making the
donor eligibility determination for either the oocyte donor or the
semen donor as required under Sec.  1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.
    The final rule also requires appropriate labeling for embryos that
would describe the donor eligibility status of the individual donors
whose gametes were used to form the embryo. The content of the labeling
is not different from that required under current regulations.
Consistent with current regulations, the intent of the labeling is to
help ensure that physicians have specific and accurate information to
provide to recipients for use in making informed medical decisions.

C. Legal Authority

    FDA has authority for this rulemaking under section 361 of the
Public Health Service Act (PHS Act) (42 U.S.C. 264). Under section 361
of the PHS Act, FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
disease between the States or from foreign countries into the States.

D. Costs and Benefits

    Because this rule imposes no additional regulatory burdens, the
costs associated with this rule are expected to be minimal.

II. Background

A. Need for the Regulation/History of This Rulemaking

    Under the authority of section 361 of the PHS Act, by delegation
from the Surgeon General and the Secretary of Health and Human
Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases.
Communicable diseases include, but are not limited to, those
transmitted by viruses, bacteria, fungi, parasites, and transmissible
spongiform encephalopathy agents. Certain diseases are transmissible
through implantation, transplantation, infusion, or transfer of HCT/Ps
derived from donors infected with those diseases. To prevent the
introduction, transmission, or spread of such communicable diseases, we
consider it necessary to require establishments to take appropriate
measures to prevent the use of HCT/Ps from infected donors. FDA
regulates HCT/Ps intended for implantation, transplantation, infusion,
or transfer into a human recipient under part 1271 that was issued
under the authority of section 361 of the PHS Act. Part 1271 requires
HCT/P establishments to screen and test donors for relevant
communicable disease agents and diseases, to prepare and follow written
standard operating procedures for the prevention of the spread of
communicable diseases, and to maintain records. Part 1271 also requires
that for most HCT/Ps, the donor must be determined to be eligible,
based on the results of screening and testing for relevant communicable
disease agents and diseases. In most cases, a donor who tests reactive
for a particular communicable disease, or who possesses clinical
evidence of, or risk factors for, communicable disease agents and
diseases, would be considered ineligible, and HCT/Ps from that donor
would not ordinarily be used.
    FDA has published three final rules that make up part 1271. In the
Federal Register of January 19, 2001 (66 FR 5447), we published
regulations requiring HCT/P establishments to register and list their
HCT/Ps with FDA (registration final rule). In the Federal Register of
May 25, 2004 (69 FR 29786), we published regulations requiring most
donors to be tested and screened for relevant communicable disease
agents and diseases (donor eligibility final rule). In the Federal
Register of November 24, 2004 (69 FR 68612), we published regulations
requiring certain HCT/P establishments to follow current good tissue
practice (CGTP), which governs the methods used in, and the facilities
and controls used for, the manufacture of HCT/Ps, recordkeeping, and
the establishment of a quality program (CGTP final rule). These
regulations apply to HCT/Ps recovered on or after May 25, 2005.
    As part of our ongoing effort to implement our framework for
regulating HCT/Ps, in the Federal Register of May 25, 2005 (70 FR
29949), we issued an interim final rule entitled ``Human Cells,
Tissues, and Cellular and Tissue-Based Products; Donor Screening and
Testing, and Related Labeling'' (2005 interim final rule), which had an
effective date simultaneous with publication. This interim final rule
was then adopted without change in the Federal Register of June 19,
2007 (72 FR 33667), in the final rule entitled ``Human Cells, Tissues,
and Cellular and Tissue-Based Products; Donor Screening and Testing,
and Related Labeling'' (2007 final rule). The 2007 final rule amended
regulations regarding the screening and testing of donors of HCT/Ps,
timing of specimen collection, record retention requirements, and
related labeling requirements in response to public comments concerning
the importance of cryopreserved embryos to individuals seeking access
to donated embryos. The 2007 final rule also added an exception to the
donor eligibility requirements in Sec.  1271.90(a)(4) for cryopreserved
embryos that, while originally exempt from the donor eligibility
requirements because the donors were sexually intimate partners, are
later intended for directed or anonymous donation.
    In recent years, industry and the medical community have expressed
concerns that the exception added by

the 2007 final rule does not fully address the need for access to
cryopreserved embryos. The stakeholders have raised concerns that the
current regulations still unduly restrict the use of embryos that were
originally intended for personal reproductive use, and therefore impose
limitations on individuals and couples involved in family building. In
response to these concerns, FDA published the proposed rule ``Revisions
to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular
and Tissue-Based Products'' in the Federal Register of December 31,
2014 (79 FR 78744). The proposed rule intended to increase access to
embryos for reproductive use by expanding the current exceptions to the
prohibitions on use under Sec.  1271.90, providing HCT/P establishments
with the flexibility to make available any embryo originally formed for
reproductive use for a specific individual or couple and now intended
for reproductive use in a directed or anonymous donation, provided that
specific criteria are met, including requirements for labeling.

B. Summary of Comments to the Proposed Rule

    We received approximately 10 comment letters on the proposed rule
by the close of the comment period. We received comments from academia,
professional organizations, and individuals. The comments were balanced
between those expressing support for the proposed rule and those
raising concerns about how the proposed exception will impact public
health. They addressed the following topics: Purpose and scope of the
final rule, donor screening, exceptions from the requirement of
determining donor eligibility, and labeling requirements.

C. General Overview of the Final Rule

    FDA is adopting as final, without material change, the proposed
rule to amend certain regulations regarding donor eligibility and
related labeling.
    We are making revisions to the following FDA regulations:
1. Amendments to Sec.  1271.90
    Section 1271.90 sets forth exceptions where HCT/P establishments
are not required to make a donor eligibility determination under Sec.
1271.50 or to perform donor screening or testing under Sec. Sec.
1271.75, 1271.80, and 1271.85. We are adding language to the exceptions
listed in this section to provide clarity and update the regulation by
allowing for an embryo originally intended for reproductive use for a
specific individual or couple, to be subsequently used for directed or
anonymous donation, even when the donor eligibility requirements under
part 1271, subpart C are not met.
    We are amending Sec.  1271.90 as follows:
     Changing the heading of this section by deleting ``from
the requirement of determining donor eligibility,'' and inserting
``other'' before ``exceptions.'' The heading for Sec.  1271.90 will
read ``Are there other exceptions and what labeling requirements
apply?'' We made this change for clarity; the new heading will be more
accurate.
     Changing Sec.  1271.90(a)(3) by replacing ``exempt'' with
``excepted,'' which is the term used in the introductory title for this
provision. Thus, this change will make the language more consistent.
The beginning of Sec.  1271.90(a)(3) will read, ``Cryopreserved cells
or tissue for reproductive use, other than embryos, originally excepted
. . . .''
     Changing current Sec.  1271.90(a)(4) by replacing
``exempt'' with ``excepted''.
     Redesignating current Sec.  1271.90(b) as Sec.  1271.90(c)
and adding a new paragraph (b) to Sec.  1271.90.
     Changing newly designated Sec.  1271.90(c) by removing
``paragraph (a)'' and adding in its place ``paragraphs (a) and (b)'' in
the introductory text, revising Sec.  1271.90(c)(2) to replace
``(b)(6)'' with ``(c)(6)'', and by adding ``recovery or'' before
``cryopreservation'' in new Sec.  1271.90(c)(6) to clarify that some
testing and screening activities may take place before recovery of the
gametes, not just before cryopreservation of the embryos.
2. Section 1271.90(b)
    We are redesignating the current Sec.  1271.90(b) to Sec.
1271.90(c), and adding a new Sec.  1271.90(b) entitled ``Exceptions for
reproductive use.'' Under finalized Sec.  1271.90(b), an embryo
originally intended for reproductive use for a specific individual or
couple that is subsequently intended for directed or anonymous donation
is excepted from the prohibition on use under Sec.  1271.45(c) even
when the applicable donor eligibility requirements under part 1271,
subpart C are not met. Accordingly, when an establishment fails to
comply with applicable donor eligibility requirements under part 1271,
subpart C, the establishment will not be prohibited from making
available for reproductive use such embryos for reproductive purposes
in accordance with this section. The exception from the prohibition on
use does not create an exception for deficiencies that occurred in
making the donor eligibility determination for either the oocyte donor
or the semen donor as required under Sec.  1271.45(b), or for
deficiencies in performing donor screening or testing, as required
under Sec. Sec.  1271.75, 1271.80, and 1271.85.
    We note that the language we are adding to the exceptions currently
listed in Sec.  1271.90 is additive. It creates an additional exception
for the use of certain reproductive HCT/Ps that are not currently
excepted, but it does not impact or restrict the exceptions currently
provided for in the regulations.
3. Section 1271.90(c)
    Under Sec.  1271.90(c), HCT/P establishments must prominently label
an HCT/P described in Sec.  1271.90(a) and (b). The labeling
requirements are intended to help ensure that physicians have specific
and accurate information to provide to recipients for use in making
informed medical decisions.
    The nonsubstantive change to Sec.  1271.90(c)(2) clarifies that the
labeling requirements contained in Sec.  1271.90(c)(2) do not apply to
reproductive cells or tissue labeled in accordance with Sec.
1271.90(c)(6). The change to Sec.  1271.90(c)(6) includes ``recovery
or'' before the word ``cryopreservation''. Thus, the Sec.
1271.90(c)(6) provision requires HCT/P establishments to prominently
label an HCT/P described in Sec.  1271.90(a)(3) or (a)(4) with ``Advise
recipient that screening and testing of the donor(s) were not performed
at the time of recovery or cryopreservation of the reproductive cells
or tissue, but have been performed subsequently'' for HCT/Ps described
in Sec.  1271.90(a)(3) or (a)(4). This change is made to recognize that
some testing and screening activities may take place even before
recovery of HCT/Ps, not just before cryopreservation.
4. Amendment to Sec.  1271.370
    Section 1271.370 sets forth labeling requirements in addition to
those that apply under Sec. Sec.  1271.55, 1271.60, 1271.65, and
1271.90. Because, as discussed previously, this rule redesignates the
current labeling requirements under Sec.  1271.90(b) to Sec.
1271.90(c), we are amending Sec.  1271.370(b)(4) to revise the
reference from Sec.  1271.90(b) to Sec.  1271.90(c).

III. Legal Authority

    FDA is issuing this final rule under the authority of section 361
of the PHS Act (42 U.S.C. 264). Under section 361 of the PHS Act, FDA
may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable disease

between the States or from foreign countries into the States. It is
important to recognize that HCT/Ps recovered in one State may be sent
to another for processing, and then shipped for use throughout the
United States, or beyond. FDA has been involved in many recalls where
HCT/Ps processed in a single establishment have been distributed in
many States. In any event, intrastate transactions affecting interstate
communicable disease transmission may also be regulated under section
361 of the PHS Act. (See Louisiana v. Mathews, 427 F. Supp. 174, 176
(E.D. La. 1977); Independent Turtle Farmers of Louisiana, Inc. v.
United States of America, et al., 2010 U.S. Dist. LEXIS 31117). This
final rule incorporates changes in response to our enhanced
understanding of the uses of certain types of HCT/Ps in specific
situations and in response to comments from stakeholders regarding the
importance of embryos to individuals and couples seeking access to
donated embryos.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 10 comment letters on the proposed rule
by the close of the comment period, each containing one or more
comments on one or more issues. We received comments from academia,
professional organizations, and individual consumers.
    We describe and respond to the comments in sections IV.B through
IV.F. We have numbered each comment to help distinguish among different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which the comments were received.

B. Description of General Comments and FDA Response

    Several comments made general remarks supporting the proposed rule
without focusing on a particular proposed provision. In the following
paragraphs, we discuss and respond to such general comments.
    (Comment 1) There were several comments that were in support of the
proposed rule and suggested that we provide even more guidance on donor
eligibility, screening, and testing of donors of reproductive cells.
One suggestion was that FDA's donor eligibility, screening, and testing
requirements closely parallel American Society of Reproductive
Medicine/Society for Assisted Reproductive Technology guidelines.
    (Response) FDA acknowledges and appreciates the supportive
comments. We appreciate the interest in additional guidance for the
screening and testing of donors of reproductive cells. We continue to
review existing regulations with respect to providing additional
guidance or modifying these regulations as appropriate, in the future.
    (Comment 2) One comment asked if the final rule would be applied
retrospectively to embryos formed and cryopreserved on or after May 25,
2005.
    (Response) Yes, the final rule applies to embryos formed and
cryopreserved on or after May 25, 2005.

C. Purpose and Scope of the Final Rule (Sec.  1271.1)

    (Comment 3) One comment noted that preventing the spread of
communicable disease protects the population and the family receiving
the donation. Two comments suggested that the proposed rule conflicts
with FDA regulations that serve to prevent the introduction,
transmission, and spread of communicable disease. One comment expressed
concern that the proposed rule appears to relax the testing
requirements for donors and conflicts with the PHS Act, specifically
section 361, that provides FDA with the authority to make and enforce
regulations ``to prevent the introduction, transmission, or spread of
communicable diseases from foreign countries into the States or
possessions, or from State or possession into any other State or
possession'' (42 U.S.C. 264(a)). This commenter's interpretation of the
proposed rule is that it removes the requirement for reproductive
tissue donors to be tested, and only requires reproductive tissue donor
testing ``when possible.'' According to the comment, FDA seems to posit
informed consent as an adequate response to the health risks faced by
recipients of donated embryos. The commenter would like FDA to strike
the qualifier ``when possible'' from the text of the proposed rule
because the commenter believes this approach would provide a greater
level of protection to the recipient than the proposed rule and
preserve FDA's intention of relaxing the current donor eligibility
regulations in the interest of family building.
    (Response) As stated previously, we consider it necessary that
establishments take appropriate measures to prevent the use of HCT/Ps
from donors infected with communicable diseases. Part 1271 requires
HCT/P establishments to screen and test donors for relevant
communicable disease agents and diseases, and to maintain records. Part
1271 also requires for most HCT/Ps that the donor must be determined to
be eligible, based on the results of screening and testing for relevant
communicable disease agents and diseases. We have retained the
qualifier ``when possible'' in Sec.  1271.90(a)(4) to provide HCT/P
establishments with the flexibility to make available any embryos
originally formed for reproductive use for a specific individual or
couple and now intended for reproductive use in a directed or anonymous
donation, provided that specific criteria are met, including
requirements for labeling.
    The final rule provides for the continued applicability of labeling
requirements for embryos intended for reproductive use that would be
excepted from the prohibition on use. The rule requires prominent
labeling that describes the donor eligibility status of the individual
donors whose gametes were used to form the embryo. The required
labeling will provide information to the treating physician to permit
discussion of the potential risks of communicable disease with the
recipient.

D. Donor Screening (Sec.  1271.75)

    (Comment 4) Some of the comments expressed concern about the risk
of accepting an unscreened donation. Another comment noted that
eligibility of the HCT/P donor must be assessed prior to usage to
ensure the safety of recipients, their offspring, and the public as a
whole; and furthermore, ensuring the proper screening of the donor's
HCT/P enables the control of the spread of disease.
    (Response) We agree that the proper screening of HCT/P donors
minimizes the risk of introducing, transmitting, or spreading
communicable diseases. As stated in the proposed rule, we consider it
necessary to require establishments to take appropriate measures to
prevent the use of HCT/Ps from infected donors. Part 1271 requires HCT/
P establishments to screen and test donors for relevant communicable
disease agents and diseases, and to maintain records. Part 1271 also
requires, for most HCT/Ps, that donor be determined to be eligible,
based on the results of screening and testing for relevant communicable
disease agents and diseases. In most cases, a donor who

tests reactive for a particular communicable disease, or who possesses
clinical evidence of, or risk factors for, a communicable disease agent
and disease, would be considered ineligible, and cells or tissues from
that donor would not ordinarily be used.
    (Comment 5) A few comments expressed the belief that the proposed
rule will allow for better genetic profiling. One of those comments
stated that labeling will make it easier to identify particular
genotypes for research. Another comment stated that genetically
profiling all donors and to the extent possible all embryos will reduce
the risk of recipients of embryos giving birth to children with serious
genetic disorders. The commenter asked FDA to require establishments to
genetically screen all donors and the embryo when possible.
    (Response) These comments address a topic that is outside the scope
of this rulemaking.

E. Exceptions From the Requirement of Determining Donor Eligibility
(Sec.  1271.90)

    (Comment 6) One comment sought transparency as to which embryos are
excepted and requested specific examples of how the rule provides
additional flexibility to make embryos available for directed and
anonymous donation. Specifically, the commenter asked whether donation
would be allowed when the embryo was originally intended for transfer
to a sexually intimate partner, where one of the gamete providers
(either a directed or anonymous donor) would be considered ineligible
based on screening and testing.
    (Response) The rulemaking provides additional flexibility to make
embryos available when there have been changes in the original plans
for use of the embryos. Under finalized Sec.  1271.90(b), an embryo
originally intended for reproductive use for a specific individual or
couple that is subsequently intended for directed or anonymous donation
is excepted from the prohibition on use under Sec.  1271.45(c) even
when the applicable donor eligibility requirements under part 1271,
subpart C are not met. Accordingly, when an establishment fails to
comply with applicable donor eligibility requirements under part 1271,
subpart C, the establishment will not be prohibited from making
available for reproductive use such embryos for reproductive purposes
in accordance with this section. The exception from the prohibition on
use does not create an exception for deficiencies that occurred in
making the donor eligibility determination for either the oocyte donor
or the semen donor as required under Sec.  1271.45(b), or for
deficiencies in performing donor screening or testing, as required
under Sec. Sec.  1271.75, 1271.80, and 1271.85.
    We note that the change we are making to the exceptions currently
listed in Sec.  1271.90 is additive. It creates an additional exception
for the use of certain reproductive HCT/Ps that are not currently
excepted, but it does not impact or restrict the exceptions currently
provided for in the regulations.
    (Comment 7) One comment recommends that the term ``embryos formed
for autologous use'' not be used in conjunction with embryos. The
commenter reasons that after a sperm or oocyte form an embryo, the
embryo should not be considered autologous, given the definition at
Sec.  1271.3(a).
    (Response) We agree with the comment and are not adopting, as part
of the final rule, the term ``embryos formed for autologous use''.
Likewise, we are not adopting, as part of the final rule, the reference
to Sec.  1271.90(a)(1) in Sec.  1271.90(a)(4).

F. Labeling Requirements (Sec.  1271.370)

    (Comment 8) Several comments were in support of labeling because it
allows the physician to fully discuss the risks of any communicable
disease and it allows the patient to make a fully informed decision.
One commenter noted that factors affecting decisions of an HCT/P
recipient may outweigh the expert advice of medical doctors. Another
comment referenced Sec.  1271.90(c)(6) of the proposed rule (embryo
labeling requirements) that states establishments are required to
``advise recipients that screening and testing of the donor(s) were not
performed at the time of recovery or cryopreservation of the
reproductive cells or tissues, but have been performed subsequently.''
The comment further states that ``Description of the Proposed Rule''
provides that these labeling requirements are ``based on the
expectation that a physician will be closely involved in the decision
of the embryo and the recognition that physicians are under legal and
ethical obligations that require them to discuss the risks of
communicable disease transmission stemming from the use of HCT/Ps.''
The comment asked that FDA revise the rule to expressly require
establishments to counsel recipients on the risk of disease.
    (Response) We agree that the recipients should be fully informed
about the risk of communicable disease before accepting an embryo for
implantation; however, we decline to make the suggested change. As
stated in the preamble of the proposed rule, the proposed labeling
requirements are based on the expectation that a physician will be
closely involved in the decision to use an embryo and the recognition
that physicians are under legal and ethical obligations that require
them to discuss the risks of communicable disease transmission stemming
from the use of HCT/Ps. FDA relies on physicians to meet these
obligations when discussing procedures involving HCT/Ps with
recipients. Further, we expect that a recipient would be fully informed
of the risks involved in using an embryo for reproductive purposes as
finalized under Sec.  1271.90(b) even when the donor eligibility
requirements under part 1271, subpart C are not met.
    (Comment 9) One comment suggested that while a labeling requirement
that is tiered according to the risks may mitigate the risks, it does
not go far enough in abolishing the risks.
    (Response) As described under proposed Sec.  1271.90(c)(2) through
(6), an embryo originally intended for reproductive use for a specific
individual or couple that is subsequently intended for directed or
anonymous donation must be labeled as applicable. We acknowledge that
the labeling requirement will not abolish all risks of implanting those
embryos. Rather, as stated in the proposed rule, the required labeling
would provide information to the treating physician to permit
discussion of the potential risks of communicable diseases with the
recipient. Our expectation is that the recipient will become fully
informed of the risk when the donor eligibility requirements under part
1271, subpart C are not met, so that the recipient can make a well
informed decision about receiving the embryo.

V. Effective Date

    This rule is effective August 22, 2016.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have

developed a comprehensive Economic Analysis of Impacts that assesses
the impacts of the final rule. We believe that this final rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the costs associated with this rule are expected to
be minimal, we certify that the rule will not have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    This rule amends certain regulations regarding donor eligibility
and labeling related to the screening and testing of donors of
particular HCT/Ps. The final rule will provide additional flexibility
to HCT/P establishments to make available for reproductive use embryos
originally intended for reproductive use for a specific individual or
couple and subsequently intended for directed or anonymous donation.
Specifically, the final rule will clarify that if an embryo was
originally intended for reproductive use for a specific individual or
couple, its use for directed or anonymous donation would not be
prohibited under Sec.  1271.45 (c), even when the applicable donor
eligibility requirements under part 1271, subpart C are not met. This
exception from prohibition for use would not create an exception for
deficiencies that occurred in making the donor eligibility
determination for either the oocyte donor or the semen donor as
required under Sec.  1271.45(b), or for deficiencies in performing
donor screening or testing, as required under Sec. Sec.  1271.75,
1271.80, and 1271,85. The final rule also requires appropriate labeling
that describes the donor eligibility status of the individual donors
whose gametes were used to form the embryo.
    This rule will provide greater accommodation of individuals and
couples wanting access to embryos originally intended for reproductive
use for a specific individual or couple, while continuing to emphasize
the applicability of the donor eligibility screening and testing
requirements for individual gamete donors. The final rule will provide
HCT/P establishments with the flexibility to make embryos originally
intended for reproductive use for a specific individual or couple now
available for directed or anonymous donation, provided that specific
criteria are met. Consistent with current regulations, the labeling
requirements will help ensure that physicians have specific and
accurate information to provide to recipients for use in making
informed medical decisions. Because this rule imposes no additional
regulatory burdens, the costs associated with this rule are expected to
be minimal.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    The labeling requirements contained in this final rule are not
subject to review by the Office of Management and Budget (OMB) because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501-3520). Rather,
the requirement to label HCT/Ps in accordance with the final rule is a
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)). Therefore, FDA concludes that these
requirements in this document are not subject to review by OMB because
they do not constitute a ``collection of information'' under the PRA.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

List of Subjects in 21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical
devices, Reporting and recordkeeping requirements.

    Therefore, under the Public Health Service Act and under authority
delegated to the Commissioner of Food and Drugs, 21 CFR part 1271 is
amended as follows:

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS

0
1. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

0
2. In Sec.  1271.90:
0
a. Revise the heading;
0
b. Revise paragraph (a)(3) introductory text;
0
c. Revise paragraph (a)(4);
0
d. Redesignate paragraph (b) as paragraph (c);
0
e. Add a new paragraph (b);
0
f. Revise newly designated paragraph (c) introductory text;
0
g. Revise newly designated paragraph (c)(2); and
0
h. Revise newly designated paragraph (c)(6).
    The revisions and additions read as follows:

Sec.  1271.90  Are there other exceptions and what labeling
requirements apply?

    (a) * * *
    (3) Cryopreserved cells or tissue for reproductive use, other than
embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this
section at the time of donation, that are subsequently intended for
directed donation, provided that:
* * * * *
    (4) A cryopreserved embryo, originally excepted under paragraph
(a)(2) of this section at the time of recovery or cryopreservation,
that is subsequently intended for directed or anonymous donation. When
possible, appropriate measures should be taken to screen and test the
semen and oocyte donors before transfer of the embryo to the recipient.
    (b) Exceptions for reproductive use. An embryo originally intended
for reproductive use for a specific individual or couple that is
subsequently intended for directed or anonymous donation for
reproductive use is excepted from the prohibition on

use under Sec.  1271.45(c) even when the applicable donor eligibility
requirements under subpart C of this part are not met. Nothing in this
paragraph creates an exception for deficiencies that occurred in making
the donor eligibility determination for either the oocyte donor or the
semen donor as required under Sec.  1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.
    (c) Required labeling. As applicable, you must prominently label an
HCT/P described in paragraphs (a) and (b) of this section as follows:
* * * * *
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have
performed all otherwise applicable screening and testing under
Sec. Sec.  1271.75, 1271.80, and 1271.85. This paragraph does not apply
to reproductive cells or tissue labeled in accordance with paragraph
(c)(6) of this section.
* * * * *
    (6) ``Advise recipient that screening and testing of the donor(s)
were not performed at the time of recovery or cryopreservation of the
reproductive cells or tissue, but have been performed subsequently,''
for paragraphs (a)(3) or (a)(4) of this section.

Sec.  1271.370

0
3. Amend Sec.  1271.370(b)(4) by removing ``Sec.  1271.90(b)'' and by
adding in its place ``Sec.  1271.90(c)''.

    Dated: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14721 Filed 6-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 1 (Tuesday, January 3, 2023)]
[Notices]
[Pages 83-85]
[FR Doc No: 2022-28482]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0047]

Port Access Route Study: Approaches to Maine, New Hampshire, and
Massachusetts

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability of draft report; request for comments.

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

SUMMARY: On March 31, 2022, the Coast Guard published a notice of study
and request for comments announcing commencement of an Approaches to
Maine, New Hampshire, and Massachusetts Port Access Route Study
(MNMPARS). This notice announces the availability of a draft report for
public review and comment. The Coast Guard is seeking public comments
on the content, proposed routing measures, and development of the
report. The recommendations of this study may lead

to future rulemakings or appropriate international agreements.

DATES: All comments and related material must be received on or before
February 2, 2022. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after
midnight, Eastern Daylight Time, on the last day of the comment period.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0047 using the Federal eRulemaking Portal (http://www.regulations.gov). See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on viewing the draft report and submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email LTJG Thomas Davis, First Coast Guard District
(dpw), U.S. Coast Guard: telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

DHS Department of Homeland Security
MNMPARS Approaches to Maine, New Hampshire, and Massachusetts Port
Access Route Study
PARS Port Access Route Study
TSS Traffic Separation Scheme
USCG United States Coast Guard

II. Background and Purpose

    Under section 70003 of title 46 of the United States Code (46
U.S.C. 70003(c)), the Commandant of the U.S. Coast Guard (USCG) may
designate necessary fairways and traffic separation schemes (TSSs) to
provide safe access routes for vessels proceeding to and from U.S.
ports. The designation of fairways and TSSs recognizes the paramount
right of navigation over all other uses in the designated areas.
    Before establishing or adjusting fairways or TSSs, the USCG must
conduct a Port Access Route Study (PARS), i.e., a study of potential
traffic density and the need for safe access routes for vessels.
Through the study process, the USCG must coordinate with federal,
state, tribal, and foreign state agencies (where appropriate) and
consider the views of maritime community representatives, environmental
groups, and other stakeholders. The primary purpose of this
coordination is, to the extent practicable, to reconcile the need for
safe access routes with other reasonable waterway uses such as
anchorages, construction, operation of renewable energy facilities,
marine sanctuary operations, commercial and recreational activities,
and other uses.
    On March 31, 2022, the Coast Guard commenced an Approaches to
Maine, New Hampshire, and Massachusetts Port Access Route Study
(MNMPARS) by publishing a notice of study and request for comments in
the Federal Register (87 FR 18800). The purpose of the MNMPARS is to
evaluate the adequacy of existing vessel routing measures and determine
whether additional vessel routing measures are necessary for port
approaches to Maine, New Hampshire, and Massachusetts and international
and domestic transit areas in the First Coast Guard District area of
responsibility.
    On June 28, 2022, the First Coast Guard District published a 60-day
Notification of Inquiry and Public Meetings; request for comments (87
FR 38418). This supplemental notice announced a schedule for six public
meetings and sought additional public comments concerning more specific
navigational safety issues. The notification requested responses to
several general and port-specific questions that were based on analysis
of historical traffic data and public comments received from the
original Notice of Study. Of the six public meetings, four were
conducted in both in-person and virtual formats, one was in-person
only, and one was virtual only.
    During both comment periods a total of 30 comments were submitted
by representatives of the maritime community, Federal and State
governmental agencies, environmental groups, non-governmental
organizations, and other stakeholders. Comments were provided during
public meetings, via email, and submitted directly to the electronic
docket. Oral comments provided during public meetings can be viewed in
the individual meeting recordings posted to the ``Documents'' section
of the public docket.
    The USCG is opening this third MNMPARS comment period to facilitate
transparent public feedback on the content and findings included in the
draft report of this study.

III. Information Requested

    The USCG is seeking all public comments on the content and
recommendations contained in the study draft report. All comments
received will be reviewed and considered before a final version of the
PARS is announced in the Federal Register.

IV. Public Participation and Request for Comments

    We encourage you to participate in the study process by commenting
on the content and development of the draft report.
    A. Viewing the draft version of the report: To view the draft
version of the MNMPARS report in the docket, go to http://www.regulations.gov, and insert ``USCG-2022-0047'' in the ``search
box''. Click ``Search''. Then, scroll to find the document entitled
``DRAFT REPORT Approaches to Maine, New Hampshire, and Massachusetts
Port Access Route Study'' under the document type ``Supporting &
Related Material.''
    B. Submitting Comments: To submit your comment online, go to http://www.regulations.gov, and insert ``USCG-2022-0047'' in the ``search
box.'' Click ``Search''. Then scroll to find the most recent ``notice''
entitled ``Port Access Route Study: Approaches to Maine, New Hampshire,
and Massachusetts'' and click ``Comment.'' The ``Comment'' button can
be found on the following pages:
     Docket Details page when a document within the docket is
open for comment,
     Document Details page when the document is open for
comment, and
     Document Search Tab with all search results open for
comment displaying a ``Comment'' button.
    Clicking ``Comment'' on any of the above pages will display the
comment form. You can enter your comment on the form, attach files
(maximum of 20 files up to 10MB each), and choose whether to identify
yourself as an individual, an organization, or anonymously. Be sure to
complete all required fields depending on which identity you have
chosen. Once you have completed all required fields and chosen an
identity, the ``Submit Comment'' button is enabled. Upon completion,
you will receive a Comment Tracking Number for your comment. For
additional step by step instructions, please see the Frequently Asked
Questions page on http://www.regulations.gov or by clicking https://www.regulations.gov/faq.
    We accept anonymous comments. Comments we post to http://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions to the docket in
response to this document, see DHS's eRulemaking System of Records
notice (85 FR 14226, March 11, 2020).
    We review all comments and materials received during the comment

period, but we may choose not to post off-topic, inappropriate, or
duplicate comments that we receive.
    C. How do I find and browse for posted comments on Regulations.gov?
On the previous version of Regulations.gov, users browsed for comments
on the Docket Details page. However, since comments are made on
individual documents, not dockets, new Regulations.gov organizes
comments under their corresponding document. To access comments and
documents submitted to this draft version of the study report go to
http://www.regulations.gov and insert ``USCG-2022-0047'' in the
``search box.'' Click ``Search.'' Then scroll down to and click on the
most recent ``notice'' entitled ``Port Access Route Study: Approaches
to Maine, New Hampshire, and Massachusetts.'' This will open to the
``Document Details'' page. Then click on the ``Browse Comments'' tab.
On the comment tab, you can search and filter comments. Note: If no
comments have been posted to a document, the ``Comments'' tab will not
appear on the Document Details page.
    D. If you need additional help navigating the new Regulations.gov.
For additional step by step instructions to submit a comment or to view
submitted comments or other documents please see the Frequently Asked
Questions (FAQs) at http://www.regulations.gov/faqs or call or email
the person in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions.
    E. 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, system of records notice regarding DHS's eRulemaking in
the March 11, 2020, issue of the Federal Register (85 FR 14226).

V. Future Actions

    Any comments received by the comment period end date will be
reviewed and considered before the final report of the MNMPARS is
announced in the Federal Register.
    This notice is published under the authority of 5 U.S.C. 552(a).

    Dated: December 22, 2022.
J. W. Mauger,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2022-28482 Filed 12-30-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17924-17925]
[FR Doc No: 2010-7891]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0174]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Applications for Food and Drug Administration Approval
to Market a New Drug: Patent Submission and Listing Requirements and
Application of 30-Month Stays on Approval of Abbreviated New Drug
Applications Certifying That a Patent Claiming a Drug is Valid or Will
Not Be Infringed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements for
submission and listing of patent information associated with a new drug
application (NDA), an amendment, or a supplement.

DATES: Submit written or electronic comments on the collection of
information by June 7, 2010.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the 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.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Applications for FDA Approval to Market a New Drug: Patent Submission
and Listing Requirements and Application of 30-month Stays on Approval
of Abbreviated New Drug Applications Certifying That a Patent Claiming
a Drug Is Invalid or Will Not Be Infringed (OMB Control Number 0910-
0513)--Extension.

    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as part
of the NDA, ``the patent number and the expiration date of any patent
which claims the drug for which the applicant submitted the application
or which claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture[,] use, or sale of
the drug.'' Section 505(c)(2) of the act (21 U.S.C. 355(c)(2)) imposes
a similar patent submission obligation on holders of approved NDAs when
the NDA holder could not have submitted the patent information with its
application. Under section 505(b)(1) of the act, we publish patent
information after approval of an NDA application in the list entitled
``Approved Drug Products with Therapeutic Equivalence Evaluations''
(the Orange Book). If patent information is submitted after NDA
approval, section 505(c)(2) of the act directs us to publish the
information upon its submission.
    FDA regulations at Sec. Sec.  314.50(h) (21 CFR 314.50(h)) and
314.53 (21 CFR 314.53) clarify the types of patent information that
must and must not be submitted to FDA as part of an NDA, an amendment,
or a supplement, and require persons submitting an NDA, an amendment,
or a supplement, or submitting information on a patent after NDA
approval, to make a detailed patent declaration using Form FDA 3542a
and Form FDA 3542.
    The reporting burden for submitting an NDA, an amendment, or
supplement in accordance with Sec.  314.50 (a) through (f), and (k) has
been estimated by FDA and the collection of information has been
approved by OMB under OMB control number 0910-0001. We are not re-
estimating these approved burdens in this document. Only the reporting
burdens associated with patent submission and listing, as explained in
the following paragraphs, are estimated in this document.
    The information collection reporting requirements are as follows:
    Section 314.50(h) requires that an NDA, an amendment, or a
supplement

contain patent information described under Sec.  314.53.
    Section 314.53 requires that an applicant submitting an NDA, an
amendment, or a supplement, except as provided in Sec.  314.53(d)(2),
submit on Forms 3542 and 3542a, the required patent information
described in this section.
    Compliance with the information collection burdens under Sec. Sec.
314.50(h) and 314.53 consists of submitting with an NDA, an amendment,
or a supplement (collectively referred to as ``application'') the
required patent declaration(s) on Form 3542a for each ``patent that
claims the drug or a method of using the drug that is the subject of
the new drug application or amendment or supplement to it and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner of the patent engaged in
the manufacture, use, or sale of the drug product'' (Sec.  314.53(b)).
Such patents claim the drug substance (active ingredient), drug product
(formulation and composition), or method of use. If a patent is issued
after the application is filed with FDA but before the application is
approved, the applicant must submit the required patent information on
Form 3542a as an amendment to the application, within 30 days of the
date of issuance of the patent.
    Within 30 days after the date of approval of an application, the
applicant must submit Form 3542 for each patent that claims the drug
substance (active ingredient), drug product (formulation and
composition), or approved method of use for listing in the Orange Book.
In addition, for patents issued after the date of approval of an
application, Form 3542 must be submitted within 30 days of the date of
issuance of the patent.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       No. of Responses per     Total Annual        Hours per
  21 CFR Section Sec.   314.50 (citing Sec.   314.53)      Respondents          Respondent           Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3542a                                                        233                   2.6                606                 20             12,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3542                                                         154                   2.6                400                  5              2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Reporting Burden Hours:                                                                                14,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of information.

    The numbers of patents submitted to FDA for listing in the Orange
Book in 2007, 2008, and 2009 were 268, 347, and 335, respectively, for
an annual average of 317 (268 patents + 347 patents + 335 patents) / 3
years = 317 patents / year). Because many of these individual patents
are included in multiple NDA submissions, there could be multiple
declarations for a single patent. From our previous review of
submissions, we believe that approximately 14 percent of the patents
submitted are included in multiple NDA submissions, and thus require
multiple patent declarations. Therefore, we estimate that 44 (317
patents x 14 percent) patents will be multiple listings, and there will
be a total of 361 patents (317 patents + 44 patents = 361 patents)
declared on Form FDA 3542. We approved 67, 73, and 77 NDAs in 2007,
2008, and 2009, respectively, of which approximately 71% submitted
patent information for listing in the Orange Book. The remaining NDAs
submitted Form 3542 as required and declared that there were no
relevant patents. We also approved approximately 88, 96, and 62 NDA
supplements in 2007, 2008, and 2009, respectively, for which submission
of a patent declaration would be required. We estimate there will be
154 instances (based on an average of 72 NDA approvals and 82
supplement approvals per year) where an NDA holder would be affected by
the patent declaration requirements, and that each of these NDA holders
would, on average, submit 2.6 declarations ((361 patent declarations +
45 no relevant patent declarations) / 154 instances = 2.6 declarations
per instance) on Form FDA 3542. We filed 120, 113, and 118 NDAs in
2007, 2008, and 2009, respectively, and 145, 99, and 104 NDA
supplements in 2007, 2008, and 2009, respectively, for which submission
of a patent declaration would be required. We estimate there will be
233 instances (based on an average of 117 NDAs filed and 116 NDA
supplements filed per year) where an NDA holder would be affected by
the patent declaration requirements. We estimate, based on a
proportional increase from the number of declarations for approved
NDAs, that there will be an annual total of 606 declarations (233
instances x 2.6 declarations per instance = 606 declarations) on Form
FDA 3542a submitted with these applications. Based upon information
provided by regulated entities and other information, we previously
estimated that the information collection burden associated with Sec.
314.50(h) (citing Sec. 314.53) and FDA Forms 3542a and 3542 will be
approximately 20 hours and 5 hours per response, respectively.
    On December 3, 2008, FDA announced in the Federal Register (73 FR
73659) the availability of a draft guidance for industry entitled
``Submission of Patent Information for Certain Old Antibiotics.'' That
draft guidance, if finalized, would provide information regarding FDA's
current thinking on the implementation of section 4(b)(1) of the Q1
Program Supplemental Funding Act (Public Law 110-379). Section 4(b)(1)
of the Q1 Act requires submission to FDA of patent information by
sponsors of certain NDAs containing old antibiotics. Estimates on the
number of Forms FDA 3542a and 3542 that might be submitted in
accordance with a finalized guidance have been included in table 1 of
this document.

    Dated: April 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7891 Filed 4-7-10; 8:45 am]
BILLING CODE 4160-01-S