[Federal Register: March 12, 2007 (Volume 72, Number 47)]
[Notices]
[Page 11016-11017]
[DOCID:fr12mr07-87]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-569-001]

Transcontinental Gas Pipe Line Corporation; Notice of Tariff
Filing

March 5, 2007.
    Take notice that on February 28, 2007, Transcontinental Gas Pipe
Line Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, the tariff sheets listed on
Appendix A to the filing, to become effective March 1, 2007.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding.

Such protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing a protest must serve a copy of that document on all the
parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-4346 Filed 3-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Proposed Rules]
[Pages 76650-76651]
[FR Doc No: 2010-30989]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0961; Airspace Docket No. 10-ANM-12]

Proposed Modification of Class E Airspace; Bryce Canyon, UT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace at Bryce
Canyon, UT to accommodate Area Navigation (RNAV) Global Positioning
System (GPS) Standard Instrument Approach Procedures at Bryce Canyon
Airport. The FAA is proposing this action to enhance the safety and
management of Instrument Flight Rules (IFR) operations at Bryce Canyon
Airport.

DATES: Comments must be received on or before January 24, 2011.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2010-
0961; Airspace Docket No. 10-ANM-12, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2010-0961 and Airspace Docket No. 10-ANM-12) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2010-0961 and Airspace Docket No. 10-ANM-12''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Bryce Canyon Airport, Bryce
Canyon, UT. Controlled airspace is necessary to accommodate aircraft
using the RNAV (GPS) Standard Instrument Approach Procedures at Bryce
Canyon Airport, Bryce Canyon, UT. This action would enhance the safety
and management of aircraft operations at the airport.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9U, dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies controlled airspace at Bryce Canyon Airport, Bryce
Canyon, UT.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9U, Airspace Designations and Reporting Points, dated August 18,
2010, and effective September 15, 2010 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM UT E5 Bryce Canyon, UT [Modified]

Bryce Canyon Airport, UT
    (Lat. 37[deg]42'23'' N., long. 112[deg]08'45'' W.)

    That airspace extending upward from 700 feet above the surface
within 8 miles each side of the 047[deg] and 227[deg] bearing from
the airport, extending 18 miles northeast and 15.9 miles southwest
of the airport. That airspace extending upward from 1,200 feet above
the surface bounded by a line beginning at lat. 38[deg]21'00'' N.,
long. 112[deg]34'00'' W.; to lat. 38[deg]21'00'' N., long.
112[deg]24'00'' W.; to lat. 38[deg]12'00'' N., long. 112[deg]15'00''
W.; to lat. 38[deg]20'00'' N., long. 111[deg]56'00'' W.; to lat.
38[deg]18'00'' N., long. 111[deg]41'00'' W.; to lat. 38[deg]00'00''
N., long. 111[deg]43'00'' W.; to lat. 37[deg]45'00'' N., long.
111[deg]02'00'' W.; to lat. 37[deg]17'00'' N., long. 111[deg]18'00''
W.; to lat. 37[deg]19'00'' N., long. 111[deg]48'00'' W.; to lat.
37[deg]22'00'' N., long. 112[deg]14'00'' W.; to lat. 37[deg]13'00''
N., long. 112[deg]33'00'' W.; to lat. 37[deg]14'00'' N., long.
112[deg]39'00'' W.; to lat. 37[deg]29'00'' N., long. 112[deg]42'00''
W.; to lat. 37[deg]41'00'' N., long. 112[deg]53'00'' W.; thence to
point of origin, and excluding that airspace within Federal airways.

    Issued in Seattle, Washington, on December 1, 2010.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2010-30989 Filed 12-8-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Notices]
[Pages 30378-30380]
[FR Doc No: 2013-12159]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69590; File No. SR-NYSE-2013-32]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of a Proposed Rule Change Proposing an Amendment to
the Bylaws of Its Wholly-Owned Subsidiary, NYSE Regulation, Inc.
(``NYSE Regulation''), To Eliminate a Requirement That Not Less Than
Two Members of the Board of Directors of NYSE Regulation Must Qualify
as ``Fair Representation Candidates''

May 16, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 8, 2013, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II
and III 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend an amendment to the bylaws of its
wholly-owned subsidiary NYSE Regulation, Inc. (``NYSE Regulation'') to
eliminate a requirement that not less than two members of the board of
directors of NYSE Regulation must qualify as ``fair representation
candidates'' (as that term is defined in those bylaws). A requirement
that such directors constitute a minimum of 20% of the board would
remain in place. The text of the proposed rule change is available on
the Exchange's Web site at www.nyse.com, 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 those 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 parts 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 is proposing to amend the Fourth Amended and Restated
Bylaws of NYSE Regulation (``NYSE Regulation Bylaws'') to eliminate the
requirement that not less than two members of the NYSE Regulation board
of directors must be ``fair representation candidates'' (as defined in
the NYSE Regulation Bylaws).\3\ However, the current requirement that
such directors constitute a minimum of 20% of the board will continue
to apply. If the number that is equal to 20% of the entire board of
directors is not a whole number, such number will be rounded up to the
next whole number, and a provision so stating would be added to the
NYSE Regulation Bylaws.
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    \3\ Section 6(b)(3) of the Act requires, as a condition for
registration of a national securities exchange, the Commission to
determine that, ``[t]he rules of the exchange assure a fair
representation of its members in the selection of its directors and
administration of its affairs . . . .'' See 15 U.S.C. 78f(b)(3).
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    As defined in the NYSE Regulation Bylaws, fair representation
candidates are Board members who are determined by member organizations
of the Exchange through a specified petition process (``Petition
Candidates'') or, in the absence of a sufficient number of Petition
Candidates, candidates recommended by the Director Candidate
Recommendation Committee (the ``DCRC'') of NYSE Regulation. In
addition, fair representation candidates for the NYSE Regulation Board
must qualify as ``non-affiliated directors'' (as such term is defined
in the NYSE Regulation Bylaws), i.e., U.S. Persons who are not members
of the board of directors of NYSE Euronext and qualify as independent
under the director independence policy of NYSE Regulation.\4\ Finally,
like all members of the NYSE Regulation Board except for the Chief
Executive Officer, fair representation candidates must qualify as
independent under the director independence policy of NYSE
Regulation.\5\
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    \4\ See Securities Act Release No. 67564 (August 1, 2012), 77 FR
47161 (August 7, 2012) (SR-NYSE-2012-17) (approving the creation of
the director independence policy of NYSE Regulation).
    \5\ The Bylaws of NYSE Regulation require that a majority of its
Board consist of non-affiliated directors. The remaining directors
are comprised of the Chief Executive Officer of NYSE Regulation and
members of the board of directors of NYSE Euronext that qualify as
independent under the NYSE Euronext independence policy. The Bylaws
do not require any affiliated directors other than the Chief
Executive Officer of NYSE Regulation.
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    The NYSE Regulation Bylaws also provide that the Board shall
consist of not less than three persons and that the number of directors
shall be fixed from time to time by the Exchange, as sole equity member
of NYSE Regulation. The size of the NYSE Regulation Board is currently
fixed at five members, of which four positions are currently filled and
one is open.\6\ The Exchange and NYSE Regulation believe that a Board
consisting of five members is sufficiently large to effectively perform
the Board's oversight responsibilities. In addition, with a Board size
of five directors, the Exchange believes that retaining the requirement
that at least two directors must be ``fair representation candidates''
is now unwarranted since such directors would constitute 40% of the
Board rather than 20% as was the case when the number of directors was
ten. The Exchange believes that the current process for selecting the
20% of directors who meet the fair representation requirement in
Section 6(b)(3), is consistent with the Act.\7\ The Exchange is not
proposing to change the NYSE Regulation independence requirements.
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    \6\ The number of directors on the NYSE Regulation board was
reduced from ten to five in early 2013 in connection with the
Financial Industry Regulatory Authority's (``FINRA'') completion of
specified milestones in the regulatory services agreement by and
among FINRA, NYSE Group, Inc., NYSE, NYSE Regulation, NYSE Arca,
Inc., and NYSE MKT LLC pursuant to which FINRA assumed
responsibility for performing the market surveillance and
enforcement functions previously conducted by NYSE Regulation.
    \7\ The Exchange represents that the DCRC of NYSE Regulation is
aware of and is in agreement with the proposed plan of
implementation. There is otherwise no change to the ``fair
representation'' candidate selection and petition process.
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    The Exchange believes that elimination of the two-director minimum
requirement for fair representation candidates is consistent with the
governance structures of other national securities exchanges that have
been approved by the Securities and Exchange Commission (the
``Commission''). For example, Article III, Section 5(e) of the By-Laws
of the NASDAQ Stock Market LLC (``NASDAQ'') requires that the
Regulatory Oversight Committee of the NASDAQ Board of Directors (the
``NASDAQ ROC''), which has an oversight role comparable to that of the
NYSE Regulation Board, must consist of three members, each of whom must
be a Public Director (i.e., ``a Director who has no material business
relationship with a broker or dealer, [NASDAQ] or its affiliates, or
FINRA'') and ``independent director'' as defined by NASDAQ Marketplace
Rule 4200. There is no requirement that the NASDAQ ROC have any members
who would be the equivalent of a fair representation candidate on the
NYSE Regulation Board.
    More recently, the Commission has approved a similar change to that
proposed herein to the Operating Agreement of the Exchange and to the
Bylaws of the Exchange's wholly owned subsidiary, NYSE Market, Inc.\8\
These changes were approved subsequent to the Commission's approval of
a structure for the board of NYSE Alternext US LLC (what is now NYSE
MKT LLC), an affiliate of the Exchange, that included a requirement
that at least 20% of the board of that organization constitute fair
representation directors, but without the requirement that there be no
less than two such directors.\9\
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    \8\ Securities Exchange Act Release No. 59683 (April 1, 2009),
74 FR 15799-01 (April 7, 2009 (SR-NYSE-2009-12).
    \9\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707, at 57711-12 (October 3, 2008) (SR-Amex-2008-62).
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    Accordingly, approval of the change to the NYSE Regulation Bylaws
proposed herein will leave NYSE Regulation with a governance structure
that is completely consistent with similar structures that the
Commission has approved for the Exchange, for other subsidiaries and
affiliates of the Exchange and for other national securities exchanges.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \10\ of the Act, in general, and furthers the
objectives of Section 6(b)(3) of the Act \11\ in particular in that it
will assure a fair representation of the members of the Exchange in the
selection of NYSE Regulation directors and in the administration of the
affairs of the Exchange and NYSE Regulation. More specifically, the
NYSE believes

that, by eliminating the current NYSE Regulation Bylaw requirement for
a minimum of two fair representation candidates on the NYSE Regulation
Board, it will be able to improve administrative efficiency and
effectiveness by operating with a smaller number of directors while
continuing to fulfill its statutory obligations regarding the fair
representation of members of the Exchange. The Exchange believes that
the proposed rule change will also further the objectives of Section
6(b)(5) of the Act \12\ as it will contribute to perfecting the
mechanism of a free and open market and a national market system, in a
manner that is consistent with the protection of investors and the
public interest.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(3).
    \12\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
relates solely to the implementation of a more efficient and effective
governance structure for NYSE Regulation and will have no effect on the
NYSE's business operations or competitive position.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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 (i) as the Commission may
designate up to 90 days of such date 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 the 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_ADDRESS>Please include
File Number SR-NYSE-2013-32 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2013-32. 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 Web site (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 Web site 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 such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NYSE-2013-32,
and should be submitted on or before June 12, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-12159 Filed 5-21-13; 8:45 am]
BILLING CODE 8011-01-P


Preliminary Initial Considerations for a Draft Proposed Standard for
General Industries, Construction and Maritime

PART 1910... - [AMENDED]		General industry

PART 1915... - [AMENDED]  	Maritime

PART 1926... -	[AMENDED] 	Construction

 (a)	Scope.

	This standard applies to occupational exposures to Beryllium in all
forms and compounds in general industry, construction, and maritime.

(b)	Definitions.

Action level means a concentration of airborne Beryllium   of XXX
micrograms per cubic meter of air (XXX (g/m3) calculated as an 8-hour
time-weighted average (TWA).

  	Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.

Beryllium [or Be] means Beryllium in any form and in any compound

Beryllium-induced Lymphocyte Proliferation Test (BeLPT) means an in
vitro measure of the beryllium antigen-specific, cell-mediated immune
response

Chronic Beryllium Disease (CDB) means a chronic lung disease
characterized by the formation of granulomas with varying degrees of
interstitial fibrosis.  The symptoms associated with chronic beryllium
disease include chest pain, cough, and/or dypsnea with relatively mild
exertion.

Director means the Director of the National Institute for Occupational
Safety and Health (NIOSH), U.S. Department of Health and Human Services,
or designee.

Employee exposure means the exposure to airborne Beryllium   that would
occur if the employee were not using a respirator.

Emergency means any occurrence that results, or is likely to result, in
an uncontrolled release of Beryllium. If an incidental release of
Beryllium can be controlled at the time of release by employees in the
immediate release area, or by maintenance personnel, it is not an
emergency.

High-efficiency particulate air [HEPA] filter means a filter that is at
least 99.97 percent efficient in removing mono- dispersed particles of
0.3 micrometers in diameter or larger.Physician or other licensed
health care professional [PLHCP] is an individual whose legally
permitted scope of practice (i.e., license, registration, or
certification) allows him or her to independently provide or be
delegated the responsibility to provide some or all of the particular
health care services required by paragraph (k) of this section.

Regulated area means an area, demarcated by the employer, where an
employee's exposure to airborne concentrations of Beryllium exceeds, or
can reasonably be expected to exceed, the PEL.

This section means this Beryllium standard.

(c)	Permissible Exposure Limit (PEL).

(1) The employer shall ensure that no employee is exposed to an airborne
concentration of Beryllium in excess of XXX microgram(s) per cubic meter
of air (XXX μg/m3), calculated as an 8-hour time-weighted average
(TWA).

(d)	Exposure Assessment.

(1)  General.

The employer shall determine the 8-hour TWA exposure for each employee
on the basis of a sufficient number of personal breathing zone air
samples to accurately characterize full shift exposure on each shift,
for each job classification, in each work area. Where an employer does
representative sampling instead of sampling all employees in order to
meet this requirement, the employer shall sample the employee(s)
expected to have the highest Beryllium exposures.

(2)  Initial Exposure Monitoring.

(i) Except as provided for in paragraphs (d)(2)(ii) and (d)(2)(iii),
each employer who has a workplace or work operation covered by this
section shall determine if any employee may be exposed to Beryllium at
or above the action level, or may be subject to routine contact with
beryllium powders, dusts or contact with contaminated surfaces, and
shall base further actions on the assessment results.

(ii) Where the employer has monitored for Beryllium   in the past 12
months, and the data were obtained during work operations conducted
under workplace conditions closely resembling the processes, types of
material, control methods, work practices, and environmental conditions
used and prevailing in the employer's current operations, and where that
monitoring satisfies all other requirements of this section, including
the accuracy and confidence levels of paragraph (d)(6), the employer may
rely on such earlier monitoring results to satisfy the requirements for
initial monitoring.

(iii) Where the employer has objective data demonstrating that a
material containing Beryllium or a specific process, operation, or
activity involving Beryllium cannot release dust, fumes, or mist of
Beryllium in concentrations at or above the action level under any
expected conditions of use, the employer may rely upon such data to
satisfy initial monitoring requirements. The data must reflect workplace
conditions closely resembling the processes, types of material, control
methods, work practices, and environmental conditions in the employer's
current operations.

(3)	Periodic Monitoring.

(i) If initial monitoring indicates that employee exposures are below
the action level, the employer may discontinue monitoring for those
employees whose exposures are represented by such monitoring.

(ii)	If initial monitoring reveals employee exposures to be at or above
the action level, the employer shall perform periodic monitoring at
least every six months.

(iii) If initial monitoring reveals employee exposures to be at or above
the PEL, the employer shall perform periodic monitoring at least every
three months.

(iv) If periodic monitoring indicates that employee exposures are below
the action level, and the result is confirmed by the result of another
monitoring taken at least seven days later, the employer may discontinue
the monitoring for those employees whose exposures are represented by
such monitoring.

(4)  Additional Monitoring.

The employer shall perform additional monitoring when there has been any
change in the production process, raw materials, equipment, personnel,
work practices, or control methods that may result in new or additional
exposures to Beryllium, or when the employer has any reason to believe
that new or additional exposures have occurred.

(5)  Employee Notification of Monitoring Results.

(i) Within 15 working days after the receipt of the results of any
monitoring performed under this section, the employer shall either
notify each affected employee individually in writing of the results or
shall post the results of the exposure monitoring in an appropriate
location that is accessible to all affected employees.

(ii) Whenever monitoring results indicate that employee exposure is
above the PEL, the employer shall describe in the written notification
the corrective action being taken to reduce employee exposure to or
below the PEL.

(6)  Accuracy of Measurement.

(i) The employer shall use a method of monitoring that produces results
that are accurate to within a statistical confidence level of 95
percent.

(ii) The employer shall use an analytical method that measures airborne
Beryllium to within an accuracy of plus or minus 25 percent (+/- 25%) at
or above the action level.

(7)  Observation of Monitoring.

(i) The employer shall provide affected employees or their designated
representatives an opportunity to observe any monitoring of employee
exposure to Beryllium.

(ii) When observation of monitoring requires entry into an area where
the use of protective clothing or equipment is required, the employer
shall provide the observer with clothing and equipment and shall assure
that the observer uses such clothing and equipment and complies with all
other applicable safety and health procedures.

(e)	Regulated Areas.

(1)  Establishment.

The employer shall establish a regulated area wherever an employee's
exposure to airborne concentrations of Beryllium   is, or can reasonably
be expected to be, in excess of the PEL.

(2)  Demarcation.

The employer shall ensure that regulated areas are demarcated from the
rest of the workplace in any manner that adequately establishes and
alerts employees of the boundaries of the regulated area.

(3)  Access.

The employer shall limit access to regulated areas to:

(i) Persons authorized by the employer and required by work duties to be
present in the regulated area;

(ii) Any person entering such an area as a designated representative of
employees for the purpose of exercising the right to observe monitoring
procedures under paragraph (d) of this section; or

(iii) Any person authorized by the Occupational Safety and Health Act or
regulations issued under it to be in a regulated area.

(f) Methods of Compliance.

	(1)	Written Exposure Control Plan.

	(i) Each employer who has a workplace or work operation with exposure
over the action level or the potential for significant skin contact
shall establish a written exposure control plan to minimize employee
exposure to airborne beryllium and employee exposure to eye or skin
contact with beryllium.

	(ii)  The exposure control plan for such employers shall contain at
least the following elements:

An inventory of locations of beryllium operations and other locations of
who are or who are likely to be exposed at these locations;

Procedures for minimizing cross-contamination;

Procedures for cleaning beryllium-contaminated products or equipment
before release from beryllium-contaminated work areas;

Procedures for cleaning beryllium-contaminated work surfaces; and

Procedures for removal, storage and cleaning or disposal of personal
protective equipment.

	(iii) Each employer shall ensure that a copy of the Exposure Control
Plan is accessible to employees in accordance with 29 CFR 1910.20(e).

(2)  Engineering and Work Practice Controls.

The employer shall use engineering and work practice controls to reduce
and maintain employee exposure to Beryllium   to or below the PEL unless
the employer can demonstrate that such controls are not feasible.
Wherever feasible engineering and work practice controls are not
sufficient to reduce employee exposure to or below the PEL, the employer
shall use them to reduce employee exposure to the lowest levels
achievable, and shall supplement them by the use of respiratory
protection that complies with the requirements of paragraph (g) of this
section.

(3)  Prohibition of Rotation.

The employer shall not rotate employees to different jobs to achieve
compliance with the PEL.

(g) Respiratory Protection.

(1) 	General.

The employer shall provide respiratory protection for employees during:

(i) Periods necessary to install or implement feasible engineering and
work practice controls;

(ii) Work operations, such as maintenance and repair activities, for
which engineering and work practice controls are not feasible;

(iii) Work operations for which an employer has implemented all feasible
engineering and work practice controls and such controls are not
sufficient to reduce exposures to or below the PEL; or

(iv) Emergencies.

(2)  Respiratory Protection Program.

Where respirator use is required by this section, the employer shall
institute a respiratory protection program in accordance with 29 CFR
1910.134.

(h)	Protective Work Clothing and Equipment.

(1)  Provision and Use.

Where employee exposure to Beryllium exceeds the PEL, or where there is
anticipated skin exposure from routine handling of beryllium powders and
dusts or contact with contaminated surfaces, the employer shall provide
appropriate personal protective clothing and equipment at no cost to the
employee, and shall ensure that the employee uses such clothing and
equipment in accordance with the written exposure control plan required
under paragraph (f)(1) of this section.(2)  Removal and Storage.

(i) The employer shall ensure that employees remove all protective
clothing and equipment contaminated with Beryllium   at the end of the
work shift or at the completion of their tasks involving Beryllium
exposure, whichever comes first, and do so only in change rooms provided
in accordance with paragraph (i) of this section.

(ii) The employer shall ensure that no employee removes
Beryllium-contaminated protective clothing or equipment from the
workplace, except for those employees whose job it is to launder, clean,
maintain, or dispose of such clothing or equipment.

(iii) When contaminated protective clothing or equipment is removed for
laundering, cleaning, maintenance, or disposal, the employer shall
ensure that it is stored and transported in sealed, impermeable bags or
other closed, impermeable containers.

(iv) Bags or containers of contaminated protective clothing or equipment
that are removed from change rooms for laundering, cleaning,
maintenance, or disposal shall be labeled in accordance with paragraph
(l) of this section.

(3)  Cleaning and Replacement.

(i) The employer shall clean, launder, repair and replace all protective
clothing and equipment required by this section as needed to maintain
its effectiveness.

(ii) The employer shall prohibit the removal of Beryllium from
protective clothing and equipment by blowing, shaking, or any other
means that disperses Beryllium into the air or onto an employee's body.

(iii) The employer shall inform any person who launders or cleans
protective clothing or equipment contaminated with Beryllium of the
potentially harmful effects of exposure to Beryllium and that the
clothing and equipment should be laundered or cleaned in a manner that
minimizes skin or eye contact with Beryllium and effectively prevents
the release of airborne Beryllium in excess of the PEL.

(i)	Hygiene Areas and Practices.

(1)  General.

Where employee exposure to Beryllium exceeds the PEL, or where there is
anticipated skin exposure from routine handling of beryllium powders and
dusts or contact with contaminated surfaces, the employer shall provide
change rooms, showers and handwashing facilities in conformance with 29
CFR 1910.141. Eating and drinking facilities provided by the employer
shall also be in conformance with 1910.141.

(2)  Change Rooms.

The employer shall assure that change rooms are equipped with separate
storage facilities for protective clothing and equipment and for street
clothes, and that these facilities prevent cross-contamination.(3)
Showers and handwashing Facilities.

(i) The employer shall provide readily accessible handwashing facilities
capable of removing Beryllium from the skin, and shall ensure that
affected employees use these facilities when necessary.

(ii) The employer shall ensure that employees who have eye or skin
contact with Beryllium wash their hands and faces at the end of the work
shift and prior to eating, drinking, smoking, chewing tobacco or gum,
applying cosmetics, or using the toilet.

(iii) The employer shall assure that employees exposed above the PEL
shower during the end of the workshift.

(4)  Eating and Drinking Facilities.

(i) Whenever the employer allows employees to consume food or beverages
at a worksite where Beryllium is present, the employer shall ensure that
eating and drinking areas and surfaces are maintained as free as
practicable of Beryllium, and that no employee in eating and drinking
facilities is exposed at any time to Beryllium at or above the action
level.

(ii) The employer shall ensure that employees do not enter eating and
drinking areas with protective work clothing or equipment unless surface
Beryllium has been removed from the clothing and equipment by methods
that do not disperse Beryllium into the air or onto an employee's body.

(5)  Prohibited Activities.

The employer shall ensure that employees do not eat, drink, smoke, chew
tobacco or gum, or apply cosmetics in regulated areas, or in areas where
skin or eye contact is reasonably anticipated; or carry the products
associated with these activities, or store those products in these
areas.

(j)	Housekeeping.

(1)  General.

The employer shall ensure that:

(i) All surfaces are maintained as free as practicable of accumulations
of Beryllium and adhere to procedures developed under the exposure
control plan required under paragraph (f)(1) of this section.

(ii)	All spills and releases of Beryllium containing material are
cleaned up promptly and adhere to procedures developed under the
exposure control plan required under paragraph (f)(1) of this section.

(2)  Cleaning Methods.

(i) The employer shall ensure that surfaces contaminated with Beryllium
are cleaned by HEPA-filter vacuuming or other methods that minimize the
likelihood of exposure to Beryllium.

(ii) Shoveling, sweeping, and brushing may be used only where
HEPA-filtered vacuuming or other methods that minimize the likelihood of
exposure to Beryllium have been tried and found not to be
effective.(iii) The employer shall not allow compressed air to be used
to remove Beryllium from any surface unless the compressed air is used
in conjunction with a ventilation system designed to capture the dust
cloud created by the compressed air.

(iv) The employer shall ensure that cleaning equipment is handled in a
manner that minimizes the reentry of Beryllium   into the workplace.

(3)  Disposal.

The employer shall ensure that:

(i) Waste, scrap, debris, and any other materials contaminated with
Beryllium and consigned for disposal are collected and disposed of in
sealed, impermeable bags or other closed, impermeable containers.

(ii) Bags or containers of waste, scrap, debris, and any other materials
contaminated with Beryllium that are consigned for disposal are labeled
in accordance with paragraph (l) of this section.

(k)	Medical Surveillance.

(1)  General.

(i) The employer shall make medical surveillance available at no cost to
the employee, and at a reasonable time and place, for all employees who
are:

(A) Occupationally exposed to Beryllium at or above the action level or
have skin exposure from routine handling of beryllium powders and dusts
or contact with contaminated surfaces;

(B) Exposed in an emergency; or

(C) Experiencing signs or symptoms of the adverse health effects
associated with Beryllium exposure.

   		(ii) The employer shall assure that all medical examinations and
procedures required by this section are performed according to generally
accepted medical practice by or under the supervision of a PLHCP.

(2)  Frequency.

	The employer shall provide a medical examination:

(i) Within 30 days after initial assignment, unless the employee has
received a Beryllium related medical examination, provided in accordance
with this standard, within the last twelve months;

     	(ii) Annually;

(iii) Within 30 days after a PLHCP's written medical opinion recommends
an additional examination;

(iv) Whenever an employee shows signs or symptoms of the adverse health
effects associated with Beryllium exposure;

(v) Within 30 days after exposure during an emergency which results in
an uncontrolled release of Beryllium; or

 (vi) At the termination of employment, unless the last examination that
satisfied the requirements of paragraph (k) of this section was less
than six months prior to the date of termination.

(3)  Contents of Examination.A medical examination consists of:

(i) A medical and work history, with emphasis on: past, present, and
anticipated future exposure to Beryllium; any history of respiratory
system dysfunction; and any positive BeLPT;

(ii) A physical examination of the skin and respiratory tract;

(iii) a BeLPT for those employees who have not previously been confirmed
positive; and

(iv) Any additional tests deemed appropriate by the examining PLHCP.

(4)  Information Provided to the PLHCP.

The employer shall ensure that the examining PLHCP has a copy of this
standard, and shall provide the following information:

(i) A description of the affected employee's former, current, and
anticipated duties as they relate to the employee's occupational
exposure to Beryllium;

  		(ii) The employee's former, current, and anticipated levels of
occupational exposure to Beryllium;

(iii) A description of any personal protective equipment used or to be
used by the employee, including when and for how long the employee has
used that equipment; and

(iv) Information from records of employment-related medical examinations
previously provided to the affected employee, currently within the
control of the employer.

(5)  PLHCP's Written Medical Opinion.

(i) The employer shall obtain a written medical opinion from the PLHCP,
within 30 days for each medical examination performed on each employee,
which contains:

(A) The PLHCP's opinion as to whether the employee has

any detected medical condition(s) that would place the employee at
increased risk of material impairment to health from further exposure to
Beryllium;

(B) Any recommended limitations upon the employee’s exposure to
Beryllium or upon the use of personal protective equipment such as
respirators;

(C) A statement that the PLHCP has explained to the employee the results
of the medical examination, including any medical conditions related to
Beryllium exposure that require further evaluation or treatment, and any
special provisions for use of protective clothing or equipment.

(ii) The PLHCP shall not reveal to the employer specific findings or
diagnoses unrelated to occupational exposure to Beryllium.

(iii) The employer shall provide a copy of the PLHCP's written medical
opinion to the examined employee within two weeks after receiving it.

(l)	Communication of Beryllium Hazards to Employees.

(1)  General.

In addition to the requirements of the Hazard Communication Standard,
29 CFR 1910.1200, for labels, material safety data sheets, and training,
employers shall comply with the following requirements.

(2)  Warning Signs.

(i) The employer shall ensure that legible and readily visible warning
signs are displayed at all approaches to regulated areas so that an
employee may read the signs and take necessary protective steps before
entering the area.

(ii) Warning signs required by paragraph (l)(2)(i) of this section shall
include at least the following information:

	DANGER

	BERYLLIUM

	RESPIRATORY AND CANCER HAZARD

	AUTHORIZED PERSONNEL ONLY

                 RESPIRATORS REQUIRED IN THIS AREA

(3)  Warning Labels.

The employer shall ensure that bags or containers of contaminated
clothing and equipment to be removed for laundering, cleaning, or
maintenance, and containers of waste, scrap, debris, and any other
materials contaminated with Beryllium that are consigned for disposal,
bear appropriate warning labels that include at least the following
information:

DANGER

	CONTAINS BERYLLIUM

	RESPIRATORY AND CANCER HAZARD

(4)  Employee Information and Training.

(i) For all employees who are potentially exposed to airborne Beryllium
or who have eye or skin contact with beryllium, the employer shall
provide training, ensure employee participation in training, and
maintain a record of the training provided.

(ii) Initial training shall be provided prior to or at the time of
initial assignment to a job involving potential exposure to Beryllium.
An employer who is able to demonstrate that a new employee has received
training within the last 12 months that addresses the elements specified
in this paragraph is not required to repeat such training provided that
the employee can demonstrate knowledge of those elements.

(iii) The employer shall provide training that is understandable to the
employee and shall ensure that each employee can demonstrate knowledge
of at least the following:

(A) The health hazards associated with Beryllium   exposure including
the signs and symptoms of chronic beryllium disease and an explanation
of the role of sensitization in developing chronic beryllium disease;

(B) The location, manner of use, and release of Beryllium in the
workplace and the specific nature of operations that could result in
exposure to Beryllium, especially exposure above the PEL;

(C) The engineering controls and work practices associated with the
employee's job assignment;

(D) The employer’s written exposure control plan

(D) The purpose, proper selection, fitting, proper use, and limitations
of respirators and protective clothing;

(E) Emergency procedures;

(F) Measures employees can take to protect themselves from exposure to
Beryllium, including modification of personal hygiene and habits;

(G) The purpose and a description of the medical surveillance program
required by paragraph (k) of this section including a description of the
BeLPT and an explanation of the possible outcomes of the test;

(H) The contents of this section; and

(I) The employee's rights of access to records under 29 CFR
1910.1020(g).

(iv) The employer shall provide additional training when:

(A) Training is necessary to ensure that each employee maintains an
understanding of the safe use and handling of Beryllium in the
workplace.

(B) Workplace changes (such as modification of equipment, tasks, or
procedures) result in an increase in employee exposures to Beryllium,
and where those exposures exceed or can reasonably be expected to exceed
the action level or result in skin or eye contact, the employer shall
provide additional training as necessary to ensure that each affected
employee understands the proper procedures for safe handling and use of
Beryllium in the workplace.

(v) The employer shall make a copy of this section and its appendices
readily available without cost to all affected employees.

(m)	Recordkeeping.

(1)  Exposure Measurements.

(i) The employer shall maintain an accurate record of all measurements
taken to monitor employee exposure to Beryllium as prescribed in
paragraph (d) of this section.

(ii) This record shall include at least the following information:

(A) The date of measurement for each sample taken;

(B) The operation involving exposure to Beryllium   that is being
monitored;

(C) Sampling and analytical methods used and evidence of their accuracy;

(D) Number, duration, and the results of samples taken;

(E) Type of personal protective equipment, such as respirators worn; and

(F) Name, social security number, and job classification of all
employees represented by the monitoring, indicating which employees
where actually monitored.

(iii) The employer shall ensure that exposure records are maintained and
made available in accordance with 29 CFR 1910.1020.

(2)  Historical Monitoring Data.

(i) Where the employer has monitored for Beryllium in the past 12
months, and has relied on this historical monitoring data to demonstrate
that exposures on a particular job will be below the action level, the
employer shall establish and maintain an accurate record of the
historical monitoring data relied upon.

(ii) The record shall include information that reflects the following
conditions:

(A) The data were collected using methods that meet the accuracy
requirements of paragraph (d)(6) of this section;

(B) The processes and work practices that were in use when the
historical monitoring data were obtained are essentially the same as
those to be used during the job for which initial monitoring will not be
performed;

(C) The characteristics of the Beryllium containing material being
handled when the historical monitoring data were obtained are the same
as those on the job for which initial monitoring will not be performed;

(D) Environmental conditions prevailing when the historical monitoring
data were obtained are the same as those on the job for which initial
monitoring will not be performed; and

(E) Other data relevant to the operations, materials, processing, or
employee exposures covered by the exception.

(iii) The employer shall maintain this record for the duration of the
employer's reliance upon such historical monitoring data and shall make
such records available in accordance with 29 CFR 1910.1020.

(3)  Objective Data.

(i) Where an employer uses objective data to satisfy initial monitoring
requirements, the employer shall establish and maintain an accurate
record of the objective data relied upon.

(ii) This record shall include at least the following information:

(A) The Beryllium-containing material in question;

(B) The source of the objective data;

(C) The testing protocol and results of testing, or analysis of the
material for the release of Beryllium;

(D) A description of the operation exempted from initial monitoring and
how the data support the exemption; and

(E) Other data relevant to the operations, materials, processing or
employee exposures covered by the exemption.

(iii) The employer shall maintain this record for the duration of the
employer's reliance upon such objective data and shall make such records
available in accordance with 29 CFR 1910.1020.

 (4)  Medical Surveillance.

(i) The employer shall establish and maintain an accurate record for
each employee covered by medical surveillance under paragraph (k) of
this section.

(ii) The record shall include the following information about the
employee:

(A) Name, social security number, and job classification;

(B) A copy of the PLHCP's written opinions;

(C) A copy of the information provided to the PLHCP as required by
paragraph (k)(4) of this section.

(iii) The employer shall ensure that medical records are maintained and
made available in accordance with 29 CFR 1910.1020.

(5)  Training.

(i) At the completion of training, the employer shall prepare a record
that indicates the identity of the individuals trained and the date the
training was completed.  This record shall be maintained for three (3)
years after the completion of training.

(ii) The employer shall provide to the Assistant Secretary or the
Director, upon request, all materials relating to employee information
and training.

(n)	Dates.

(1)  Effective Date.

This section shall become effective [insert date 60 days after
publication in the Federal Register].

(2)  Start-Up Dates.

All obligations of this section commence 90 days after the effective
date except as follows:

(i) Change rooms required by paragraph (i) of this section shall be
provided no later than 1 year after the effective date.

(ii) Engineering controls required by paragraph (f) of this section
shall be implemented no later than two (2) years after the effective
date.

DRAFT DO NOT CITE OR QUOTE

 PAGE

f

This information is distributed solely for the purpose of SBREFA review
under the Regulatory Flexibility Act.  It has not been formally
disseminated by OSHA.  It does not represent and should not be construed
to represent any agency determination or policy.


[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76200-76203]
[FR Doc No: 2022-27016]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1794]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Drug Labeling
Provisions and Over-the-Counter Monograph Drug User Fee Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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 January 12, 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 0910-0340. 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, 10A-12M, 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.

General Drug Labeling Provisions and OTC Monograph Drug User Fee
Submissions--21 CFR Part 201

OMB Control Number 0910-0340--Revision

I. Over-the-Counter (OTC) Drug Product Labeling

    This information collection supports implementation of general drug
labeling provisions, including certain OTC drug product labeling
requirements found in FDA regulations in 21 CFR part 201 and in section
502(x) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug product labeling recommendations
discussed in FDA guidance documents enumerated below. The requirements
and recommendations contained in this authority help ensure that OTC
drug product labeling includes information to assist consumers with
product selection and with the safe and effective use of products that
protect the public health from potential harm that could result from
the dissemination of false and misleading statements regarding FDA-
regulated products. As described further below, the information
collection provisions of one guidance also apply to prescription drug
labeling.

A. Principal Display Panel Labeling

    Certain information collection provisions address the labeling
(third-party disclosures) that drug companies provide on the principal
display panel of every OTC drug product in package form--the part of
that drug product's label that is most likely to be displayed or
examined in a retail sale setting (see 21 CFR 201.60). Information on
this panel supports consumers' product selection, as well as
identification after purchase. OTC drug product companies must include
a declaration of the net quantity of the OTC product contents on the
principal display panel (see Sec.  201.62 (21 CFR 201.62)). They also
must include a statement of identity (see Sec.  201.61 (21 CFR
201.61)).
    FDA has made available a draft guidance for industry entitled
``Statement of Identity and Strength--Content and Format of Labeling
for Human Nonprescription Drug Products'' \1\ (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) that further addresses content and
format of statement of identity information and drug product strength
information to be included in the principal display panel labeling of
human nonprescription drug products. The guidance provides
recommendations to help manufacturers comply with statement of identity
labeling requirements under Sec.  201.61 and also provides a
recommended alternative to the statement required by that regulation to
provide consumers with consistent information about the active
ingredients, strength, and dosage form of the product. Consistent
information about the active ingredients, strength, and dosage form of
the product on the principal display panel may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection of these products and in subsequent
identification of the products after purchase.
---------------------------------------------------------------------------

    \1\ When final, this guidance will represent FDA's current
thinking on this topic.
---------------------------------------------------------------------------

    In estimating burden for statement of identity labeling, we have
excluded the burden for disclosing any statement of identity specified
in a final OTC monograph order under section 505G of the FD&C Act (21
U.S.C. 355h), because FDA regulations state that for purposes of Sec.
201.61, the statement of identity shall be the term or phrase used in
an applicable OTC monograph (see 21 CFR 330.1(c)(1)). By operation of
law, OTC monographs are now established by order under section 505G of
the FD&C Act, and information collections made under section 505G are
exempt from the PRA under section 505G(o) of the FD&C Act.

B. OTC Drug and Prescription Drug Facts Labeling

    In addition to labeling that drug companies provide on the
principal display panel, companies must also comply with Agency
regulations in Sec.  201.66 (21 CFR 201.66), which requires standard
content elements and formatting for the ``Drug Facts'' labeling (DFL)
of all OTC drug products. This standardized labeling helps consumers
understand the information that appears on OTC drug products to help
ensure that consumers can use those products safely and effectively.
The use of consistent language in labeling headings and subheadings
helps consumers comprehend information, and consistent formatting helps
consumers more efficiently locate information.
    The DFL is where OTC drug product labeling presents certain
specific, standardized content required or recommended under other
regulations

or guidance documents. For this reason, our burden estimates address
these information collections together. One such provision authorizes
the optional use of a symbol to convey warnings regarding use of an OTC
drug product while pregnant or breast-feeding (see Sec.  201.63(a) (21
CFR 201.63(a)). In addition, the DFL is where OTC drug product labeling
presents information (if applicable) on the quantity per dosage unit of
certain specific substances. Some consumers need to restrict their
total daily intake of these substances because of their impact on the
consumers' underlying health conditions. Specific quantitative
information must be presented in OTC drug product labeling for
phenylalanine/aspartame (Sec.  201.21(b) (21 CFR 201.21(b))), sodium
(Sec.  201.64(b) (21 CFR 201.64(b))), calcium (Sec.  201.70(b) (21 CFR
201.70(b))), magnesium (Sec.  201.71(b) (21 CFR 201.71(b))), and
potassium (Sec.  201.72(b) (21 CFR 201.72(b))).
    The quantitative labeling requirements in those regulations cited
above are complemented by the draft guidance for industry entitled
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug Products'' \2\ (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) (Quantitative Sodium, Potassium,
and Phosphorus Labeling Guidance). This draft guidance document
provides content and formatting recommendations for presenting
quantitative information about sodium, potassium, and phosphorus that
can help firms comply with the requirements under Sec. Sec.  201.64 and
201.72 for conveying information about these substances in OTC drug
product labeling. The draft guidance also provides parallel
recommendations for drug companies to provide quantitative information
about phosphorus in OTC drug product labeling. This quantitative
information about sodium, potassium, and phosphorus helps patients who
need to limit their overall consumption of any of these substances
because of its impact on underlying health conditions, such as heart
failure, hypertension, or chronic kidney disease. Quantifying these
substances in drug labeling can also help healthcare providers and
patients select drug products with lower amounts of these substances
when such alternatives are available. The draft guidance recommends
approaches to improve consistency in the presentation of this
information, including clarifying quantities per dosage unit and
rounding consistency. The information collections addressed in the
draft guidance with regard to OTC drug products are included with our
estimates for preparing the DFL panel of labeling, where this
information appears.
---------------------------------------------------------------------------

    \2\ When final, this guidance will represent FDA's current
thinking on this topic.
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    The Quantitative Sodium, Potassium, and Phosphorus Labeling
Guidance also recommends how drug firms can provide quantitative
information on sodium, potassium, and phosphorus in prescription drug
labeling to help patients who need to limit their overall consumption
of these substances. Prescription drugs are not subject to the OTC
labeling regulations, but the content and format of prescription drug
labeling is set forth in 21 CFR 201.56 and 201.57 and approved under
OMB control number 0910-0572. In the guidance, FDA recommends that when
the recommended quantitative information about sodium, potassium, and
phosphorus is included in prescription drug labeling, it should be
presented within the DESCRIPTION section of that labeling, following
the list of inactive ingredients. We estimate that the recommendations
of the guidance regarding disclosing quantitative information about
sodium, potassium, and phosphorus in prescription drug labeling will
have no effect on the overall burden estimate for prescription drug
labeling as a whole, which is addressed under OMB control number 0910-
0572.
    Our estimate of burden for OTC drug labeling that appears within
the DFL reflects several considerations. For those OTC drug products
that are marketed pursuant to an application approved under section 505
of the FD&C Act (21 U.S.C. 355), we assume a substantial part of the
burden of developing labeling is addressed in the submission of the new
drug application, which includes submission of the proposed labeling.
The information collections associated with new drug applications are
approved under OMB control number 0910-0001. For OTC drugs that are
legally marketed under section 505G of the FD&C Act that do not have an
approved application under section 505 of the FD&C Act, a substantial
part of the DFL's content, including applicable Uses (Indications),
Warnings, and Directions, is established under section 505G, either by
final administrative orders or by section 505G(a)(3) of the FD&C Act.
Collections of information made under section 505G of the FD&C Act are
exempt from the PRA. Therefore, labeling required by administrative
orders under section 505G of the FD&C Act or required by section
505G(a)(3) of the FD&C Act, even if it would ordinarily be a collection
of information,\3\ is exempt from the PRA and is not considered in our
burden estimate for the DFL (see section 505G(o) of the FD&C Act).
Finally, we note that the DFL of many individual products already being
marketed will remain unchanged within a given year. Thus, our
annualized burden estimate encompasses only new products or those
otherwise undergoing changes, such as reformulation, or changes in
package quantity that necessitate revisions to the DFL, whether those
products are marketed under approved applications (e.g., new drug
application/abbreviated new drug application) or pursuant to section
505G of the FD&C Act.
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    \3\ Some labeling required by these administrative orders or
section 505G(a)(3) of the FD&C Act is not a collection of
information at all, but rather, is the public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public (see 5 CFR
1320.3(c)(2))).
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    Our annualized estimate of burden addresses new products and
products for which the DFL and/or net quantity of contents otherwise
change in a 12-month period.

C. Labeling Related to Adverse Event Reporting

    Section 502(x) of the FD&C Act requires the label of a
nonprescription drug product marketed in the United States without an
application approved under section 505 of the FD&C Act to include a
domestic address or domestic telephone number through which a
manufacturer, packer, and distributor may receive a report of a serious
adverse event associated with its product(s). To help implement this
provision, we developed the guidance for industry entitled ``Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers'' (September 2009)
(available at https://www.fda.gov/media/77411/download). This guidance
document is intended to assist respondents in complying with this
statutory labeling requirement and provides recommendations for
manufacturers to include an additional labeling statement identifying
the purpose of the domestic address or telephone number to improve the
usefulness of the labeling for consumers.

D. Submissions To Request Exemptions or Deferrals From OTC Drug
Labeling Requirements

    FDA regulations in Sec.  201.66(e) authorize FDA to exempt or defer
specific requirements in Sec.  201.66 if FDA finds that the requirement
is inapplicable, impracticable, or contrary to public health or safety.
A manufacturer, packer, or distributor can seek such an exemption or
deferral by submitting a written request in accordance with the
requirements of Sec.  201.66(e), which address the content of such a
written request submission and how and where to submit it. A request
for an exemption or deferral must be submitted in triplicate for each
OTC drug product and contain certain information allowing the Agency to
make an informed decision on the request. FDA uses the submitted
information to assess whether the grounds for an exemption or deferral
are met. Based on historical experience and from feedback received from
respondents who have submitted similar requests, FDA estimates that it
will take 24 hours to prepare and submit each submission and that on
average annually, the Agency will receive one request for a waiver or
exemption from the drug labeling requirement.
    In addition, Sec.  201.63(d) states that FDA may grant exemptions
from the specific OTC drug product warning for patients who are
pregnant or breast feeding that is ordinarily required to appear in
labeling by Sec.  201.63(a). To request such an exemption, the
regulations call for submission of a citizen petition in accordance
with Sec.  10.30 (21 CFR 10.30). The submission of citizen petitions
under Sec.  10.30, including those petitions that request this labeling
exemption, is approved under OMB control number 0910-0191, and we do
not address its burden further in this document.
    In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
  Information collection activity--labeling       Number of     disclosures per    Total annual        Average burden per disclosure       Total hours 2
                                                 respondents       respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Declaration of Net Quantity of Contents                   875                  9           7,918  0.5 (30 minutes)......................           3,959
 Labeling for Nonprescription Drug Products--
 Sec.   201.62.
Statement of Identity Labeling for                        292               11.5           3,383  2.5...................................         8,457.5
 Nonprescription Drug Products that are not
 covered by a final OTC Drug Monograph under
 section 505G of the FD&C Act--Sec.   201.61.
Additional Statement of Identity and Strength             292               11.5           3,383  2.5...................................         8,457.5
 information in labeling of nonprescription
 drug products that are not covered by a
 final OTC Drug Monograph under section 505G
 of the FD&C Act (Guidance For Industry
 (GFI): Statement of Identity and Strength--
 Content and Format of Labeling for Human
 Nonprescription Drug Products, section III).
Additional Statement of Identity and Dosage               292                 19           5,614  2.5...................................          14,035
 Form information in labeling of
 nonprescription drug products that are
 covered by a final OTC Drug Monograph under
 FD&C Act section 505G (GFI: Statement of
 Identity and Strength--Content and Format of
 Labeling for Human Nonprescription Drug
 Products, section III).
DFL for Nonprescription Drug Products--Sec.               875                  9           7,918  12....................................          95,016
 201.66(c) and (d) (including content within
 DFL described in Sec.  Sec.   201.21(b),
 201.63(a), 201.64(b), 201.70(b), 201.71(b),
 201.72(b), or in guidance)..
Address and phone number of responsible                   300                  3             900  4.....................................           3,600
 person added to labeling for nonprescription
 drug products marketed without an
 application approved under section 502(x) of
 the FD&C Act and GFI: Labeling of
 Nonprescription Human Drug Products Marketed
 Without an Approved Application as Required
 by the Dietary Supplement and
 Nonprescription Drug Consumer Protection
 Act: Q&A--section III).
    Total....................................  ..............  .................  ..............  ......................................         133,525
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

                                     Table 2--Estimated Annual Third-Party Reporting Burden for OTC Drug Products 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
             Information collection activity--labeling                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for exemptions/deferrals of OTC drug product Drug Facts                  1                1                1               24               24
 labeling requirements--Sec.   201.66(e)...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. OTC Monograph Drug User Fee Program Submissions

    This information collection also includes submissions associated
with the OTC Monograph Drug User Fee Program. Section 744M of the FD&C
Act (21 U.S.C. 379j-72) establishes an OTC monograph drug user fee
program (commonly called OMUFA) and authorizes FDA to assess and
collect: (1) facility fees from qualifying OTC monograph drug
facilities and (2) fees from submitters of qualifying OTC Monograph
Order Requests (OMORs). The OMUFA program supports FDA activities
related to the regulation of OTC monograph drug products, including
provisions of section 505G of the FD&C Act that facilitate innovation
and make it easier for FDA to better respond to safety issues when they
emerge. We provide information regarding the OMUFA program on our
website at https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa.

    We developed Form FDA 5009, Over-The-Counter Monograph User Fee
Cover Sheet, (available at https://www.fda.gov/about-fda/reports-manuals-forms/forms, Search for Form FDA 5009) to facilitate the
submission of OMUFA fees and to more efficiently administer the OMUFA
program. Form FDA 5009 provides FDA with necessary information to
determine the total user fee payment amount required and to help the
Agency track payments. Respondents to this collection are qualifying
finished dosage form manufacturers of OTC monograph drugs and
submitters of qualifying OMORs submitted under section 505G(b)(5) of
the FD&C Act.
    In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the collection of information as follows:

                                                  Table 3--Estimated Annual OMUFA Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
       Form FDA 5009--OMUFA cover sheet            Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission associated with facility fees......           1,184               1           1,184  0.5 (30 minutes)........................             592
Submission associated with fees for qualifying               5               1               5  0.5 (30 minutes)........................             2.5
 OMORs.
                                               ------------------------------------------------                                          ---------------
    Total.....................................  ..............  ..............  ..............  ........................................           594.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on data from our electronic Drug Registration and Listing
System, we estimate that there will be 1,184 respondents who will
provide information in conjunction with facility fee payments annually.
In addition, consistent with the ``Over-the-Counter Monograph User
Program Performance Goals and Procedures'' commitment letter (available
at https://www.fda.gov/media/106407/download), we estimate submitters
will provide the user fee information using Form FDA 5009 in
conjunction with an average of five qualifying OMORs annually. We
assume the user fee-related submissions will require an average of 30
minutes to prepare, for a total of 594.5 hours annually.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27016 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P