[Federal Register Volume 78, Number 240 (Friday, December 13, 2013)]
[Rules and Regulations]
[Pages 75902-75904]
[FR Doc No: 2013-29588]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0603; FRL-9904-12-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Philadelphia County Reasonably Available Control
Technology Under the 1997 8-Hour Ozone National Ambient Air Quality
Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is conditionally
approving two State Implementation Plan (SIP) revisions for the
Commonwealth of Pennsylvania. The SIP revisions consist of a
demonstration that Philadelphia County is meeting the requirements of
reasonably available control technology (RACT) of the Clean Air Act
(CAA) for nitrogen oxides (NOX) and volatile organic
compounds (VOC) under the 1997 8-hour ozone national ambient air
quality standard (NAAQS). EPA's conditional approval of Philadelphia
County's 1997 8-hour ozone RACT demonstration is based on Philadelphia
County's commitment to submit additional SIP revisions addressing
source-specific RACT controls for major sources of VOC and
NOX in the County. This action is being taken under the CAA.

DATES: This final rule is effective on January 13, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2008-0603. All documents in the electronic docket
are listed in the www.regulations.gov Web page. Although listed in the
index, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in www.regulations.gov or in hard copy
during normal business hours at the Air Protection Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. Copies of the State submittal are
available at the Department of Public Health, Air Management Services,
321 University Avenue, Philadelphia, Pennsylvania 19104. Copies are
also available at Pennsylvania Department of Environmental Protection,
Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street,
Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 19, 2013 (78 FR 36716), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. In the NPR, EPA
proposed conditional approval of Philadelphia County's SIP revisions
addressing the RACT requirements under the 1997 8-hour ozone NAAQS. The
formal SIP revisions were submitted by the Pennsylvania Department of
Environmental Protection (PADEP) on behalf of Philadelphia Air
Management Services (AMS) on September 29, 2006 and June 22, 2010
(hereafter the 2006 SIP revision and the 2010 SIP revision,
respectively).
    On November 29, 2005, EPA published an ozone implementation rule to
address nonattainment SIP requirements for the 1997 8-hour ozone NAAQS
(the Phase 2 Ozone Implementation Rule). See (70 FR 71612 (November,
29, 2005). In the Phase 2 Ozone Implementation Rule, EPA required that
states meet the RACT requirements under the 1997 8-hour ozone NAAQS,
either through a certification that previously adopted RACT controls in
their SIP approved by EPA under the 1-hour ozone NAAQS continue to
represent adequate RACT control levels for 8-hour ozone attainment
purposes, or through the adoption of new or more stringent regulations
that represent RACT control levels. See 70 FR 71655.
    However, the Court of Appeals for the District of Columbia Circuit
subsequently held that a particular provision in the Phase 2 Ozone
Implementation Rule, which allowed the NOX SIP call, a cap-
and-trade program for NOX, to substitute as RACT for
electric generating units (EGUs) for the 1997 ozone NAAQS, was
inconsistent with the statutory requirements of section 172(c)(1) of
the CAA and remanded that provision of the rule to EPA. See NRDC v.
EPA, 571 F.3d 1245 (D.C. Cir. 2009). Since the Philadelphia County 2006
SIP revision relies on the NOX SIP Call to meet the
NOX RACT requirements for EGUs and it does not specifically
and sufficiently address the source-specific RACT determinations for 46
major sources that were previously approved under the 1-hour ozone
standard, EPA determined that it cannot proceed with the final approval
of this SIP revision, as proposed on August 26, 2008 (73 FR 50270) and
on June 19, 2013 (78 FR 36716), withdrew the August 26, 2008 proposed
rulemaking action to approve the 2006 SIP revision.

II. Summary of SIP Revisions

    On September 29, 2006, PADEP submitted on behalf of AMS a SIP
revision for Philadelphia County to meet the RACT requirements for the
1997 8-hour ozone NAAQS. The 2006 SIP revision consists of a RACT
demonstration for Philadelphia County for NOX and VOC, and
includes: (1) A certification that previously adopted RACT controls in
Pennsylvania's SIP that were approved by EPA for Philadelphia County
under the 1-hour ozone NAAQS are based on the currently available
technically and economically feasible controls and continue to
represent RACT for the 8-hour implementation purposes; (2) the adoption
of Federally enforceable permits that represent RACT control levels for
four major VOC sources; and (3) a negative declaration that certain VOC
sources do not exist in Philadelphia County.
    On June 22, 2010, PADEP submitted another SIP revision addressing
Philadelphia County's RACT requirements under the 1997 8-hour ozone
standard. The 2010 SIP revision consists of: (1) The adoption of two
regulations to meet control technique guideline (CTG) RACT
requirements; and (2) a negative declaration for a particular CTG
source category. The 2010 SIP revision supersedes portions of the 2006
SIP revision addressing specific CTG RACT requirements.
    Finally, on April 26, 2013, PADEP submitted on behalf of AMS a
letter committing to submit additional SIP revisions to address source-
specific RACT controls under the 1997 8-hour ozone standard for
Philadelphia County pursuant to section 110(k)(4) of the CAA.
Additional details on the SIP revisions are included in the NPR and
will not be restated here. No public comments were received on the NPR
for this action.

III. EPA's Rationale for Conditional Approval

    In light of the DC Circuit decision in NRDC v. EPA regarding
requirements in the Phase 2 Ozone Implementation Rule, EPA determined
it could not approve the presumption in the 2006 SIP submittal that the
NOX SIP Call constitutes RACT for EGU sources in
Philadelphia County. Thus, AMS needs to perform a NOX RACT
analysis for EGUs as provided in the April 26, 2013 commitment letter
from PADEP for AMS. EPA also determined that the 2006 SIP revision does
not specifically and sufficiently address whether the source-specific
RACT controls for 46 major sources in Philadelphia County that were
previously approved in the Pennsylvania SIP under the 1-hour ozone
NAAQS continue to represent RACT for the 1997 8-hour ozone NAAQS.
Therefore, to satisfy the major source RACT requirement for the 1997 8-
hour ozone NAAQS, AMS must either: (1) Provide a certification that
previously adopted source-specific RACT controls approved by EPA in
Pennsylvania's SIP under the 1-hour ozone NAAQS for major sources in
Philadelphia County (as listed in 40 CFR 52.2020(d)(1)) continue to
represent adequately RACT for the 1997 8-hour ozone NAAQS; or (2)
perform a source-specific RACT analysis for each source for which
controls do not currently and adequately represent RACT for the 1997 8-
hour ozone NAAQS.
    In this rulemaking action, EPA is conditionally approving
Philadelphia County's 1997 8-hour ozone RACT demonstration provided in
the 2006 and 2010 SIP revisions, based upon the commitment from AMS in
the April 26, 2013 letter from PADEP to submit additional SIP revisions
to address the deficiencies in the current RACT demonstration for
Philadelphia County. The SIP revisions, to be submitted by PADEP on
behalf of AMS no later than twelve months from today's final
conditional approval, will address source-specific RACT determinations
for the following major sources in Philadelphia County: (1) Exelon--
Delaware Station; (2) Exelon--Richmond Station; (3) Exelon--Schuylkill
Station; (4) Veolia--Edison Station (formerly Trigen- Edison Station);
(5) Veolia--Schuylkill Station (formerly Trigen--Schuylkill Station);
(6) Philadelphia Energy Solutions Refinery (formerly Sunoco Refinery);
(7) Kraft Nabisco (formerly Nabisco Biscuit Company); (8) Temple
University, Health Sciences Center; (9) GATX Terminals Corporation; and
(10) Honeywell (formerly Sunoco Chemicals, Frankford Plant). The SIP
revisions to be submitted will also include a certification that
previously adopted source-specific RACT controls approved by EPA in
Pennsylvania's SIP for the 1-hour ozone NAAQS for the remaining sources
in Philadelphia County continue to represent adequately RACT for the
1997 8-hour ozone NAAQS.

IV. Final Action

    In this rulemaking action, EPA is conditionally approving
Philadelphia County's RACT demonstration under the 1997 8-hour ozone
NAAQS, as provided in the 2006 and the 2010 SIP revisions. Pursuant to
section 110(k)(4) of the CAA, this conditional approval is based upon
the April 26, 2013 letter from PADEP for AMS committing to submit to
EPA, no later than twelve months from today's final conditional
approval, additional SIP revisions to address the deficiencies in the
current RACT demonstration for Philadelphia County. The SIP revisions
will provide source-specific RACT determinations for 10 major sources
of VOC and NOX in Philadelphia County and a certification
that previously adopted source-specific RACT controls approved by EPA
in Pennsylvania's SIP for the 1-hour ozone NAAQS for the remaining
sources in Philadelphia County continue to adequately represent RACT
for the 1997 8-hour ozone NAAQS. Once EPA has determined that AMS has
satisfied this condition, EPA shall remove the conditional nature of
this approval and Philadelphia County's 1997 8-hour ozone RACT
demonstration will, at that time, receive a full approval status.
Should AMS fail to meet the condition specified above, today's final
conditional approval of Philadelphia County's 1997 8-hour ozone RACT
demonstration will convert to a disapproval.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it

is published in the Federal Register. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 11, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action [add language that is unique to this action] may
not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: November 29, 2013.
 W.C. Early,
Acting Regional Administrator, Region III.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
an entry for ``RACT under the 1997 8-hour ozone NAAQS'' for
Philadelphia County at the end of the table. The added text reads as
follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

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    Name of non-regulatory SIP          Applicable           State                                Additional
             revision                geographic area    submittal date   EPA Approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
RACT under the 1997 8-hour ozone   Philadelphia County         9/29/06  12/13/13 [Insert     Conditional
 NAAQS.                                                        6/22/10   page number where    approval. See Sec.
                                                                         the document           52.2023(l).
                                                                         begins].
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0
3. Section 52.2023 is amended by adding paragraph (l) to read as
follows:

Sec.  52.2023  Approval status.

* * * * *
    (l) EPA conditionally approves Philadelphia County's reasonably
available control technology (RACT) demonstration under the 1997 8-hour
ozone NAAQS, as provided in SIP revisions submitted on September 29,
2006 and June 22, 2010. Pursuant to section 110(k)(4) of the CAA, this
conditional approval is based upon an April 26, 2013 letter from
Pennsylvania on behalf of Philadelphia County committing to submit to
EPA, no later than twelve months from EPA's final conditional approval,
additional SIP revisions to address the deficiencies in the current
RACT demonstration for Philadelphia County. The SIP revisions, to be
submitted by Pennsylvania on behalf of Philadelphia County, will
address source-specific RACT determinations for ten (10) major sources
in Philadelphia County and will include a certification that previously
adopted source-specific RACT controls approved by EPA in Pennsylvania's
SIP under the 1-hour ozone NAAQS for the remaining sources in
Philadelphia County (as listed in 40 CFR 52.2020(d)(1)) continue to
adequately represent RACT for the 1997 8-hour ozone NAAQS.

[FR Doc. 2013-29588 Filed 12-12-13; 8:45 am]
BILLING CODE 6560-50-P


FY 2011 End of Year (EOY) Reporting Protocol for “SP-4”

Action	No Later Than

States should report two numbers -- the numbers of Community Water
Systems (CWS) that have substantially implemented Source Water
Protection (SWP) according to the state definition and the population
served by those CWS.  States have the option of reporting to their
Regional Office or through SDWIS (Attachment B).  Any changes to a
state’s definition of substantial implementation should be documented
and provided to the region.  	Regions Determine

It is helpful to HQ if you use the sample reporting template (below).
For each state, the Region should indicate whether or not the state is
reporting through SDWIS.  If “Yes,” indicate the date that the state
formally notified the region (must be by June 30).  For states
continuing to report to the regions, “No,” document the numbers of
CWS and the population served by those water systems.  If there has been
a change to any state’s definition of substantial implementation, the
changes should be provided to HQ.   E-mail the table and any narrative
to Beth Hall<EMAIL_ADDRESS> 	Weds, Sept. 14

Headquarters will use SDWIS and the tables to calculate the percentages
of CWS and population served for each State, and for the Region, based
on Q3/FY2011 SDWIS-FED denominators and return those data to the
Regions.	Tuesday, October 4

Once the Regions have, for each state, the final percentages, the
Regions can complete entry of the final percentages of CWS and of the
population served, into ACS.  Please make note in the ACS comment field
provided if a state’s definition of substantial implementation has
changed.  	Mid October

Sample Reporting Template for Regions

CWS that have achieved “substantial implementation” according to
each State’s definition.  (cumulative)

State	Reporting SDWIS ?	For Y, date

Notification received	# CWSs	Population Served

Connecticut  	Yes/No

Maine  	Yes/No

	Massachusetts  	Yes/No

	New Hampshire  	Yes/No

	Rhode Island  	Yes/No

	Vermont  	Yes/No

	Narrative:

Regions II – X :   Please replace Region I state names with your
states’ names.


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request Environmental Protection Agency/ OSWER 2. OMB control number b. G None a. 2 0 5 0  0 1 3 9 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c.

Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a.

Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes

No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.

Three years from approval date b. G Other Specify: / /___

7. Title Reporting and Recordkeeping Requirements Under EPA's WasteWise Program ( Renewal)

8. Agency form number( s) ( If applicable) 1698.05 9. Keywords solid waste, voluntary 10. Abstract EPA needs to collect this information to evaluate the success of the voluntary WasteWise program and the progress of members participating in the program. The information is used to recognize members' achievements and identify successful waste reduction strategies to share with others. Members are predominantly businesses, as well as some non profits, trade associations, institutions, and federal, state, local and tribal governments.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. P Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,425 b. Total annual responses 1,525 1. Percentage of these responses collected electronically 35 % c. Total hours requested 56,350 d. Current OMB inventory 64,260 e. Difference  7,910 f. Explanation of difference 1. Program Change  7,910 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. P Program evaluation f. _ Research c. __ General purpose statistics g. _ Regulatory or compliance d. _ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c.

Reporting 1.

On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6.

Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Charles Heizenroth Phone: ( 703) 308 0154 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

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

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

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

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

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

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

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

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

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

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

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

Signature of Program Official Lillian Bagus, Director Municipal and Industrial Solid Waste Division Office of Solid Waste Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20513-20518]
[FR Doc No: 2011-8885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. FDA-2010-N-0099]

Revision of the Requirements for Constituent Materials

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations to permit the Director of the Center for
Biologics Evaluation and Research (CBER) or the Director of the Center
for Drug Evaluation and Research (CDER), as appropriate, to approve
exceptions or alternatives to the regulation for constituent materials.
A request for an exception or alternative will be considered for
approval when the data submitted in support of such a request establish
the safety, purity, and potency of the biological product for the
conditions of use, including indication and patient population, for
which the applicant is seeking approval. FDA is taking this action due
to advances in developing and manufacturing safe, pure, and potent
biological products licensed under the Public Health Service Act (the
PHS Act) that, in some instances, render the existing constituent
materials regulation too prescriptive and unnecessarily restrictive.
This rule provides manufacturers of biological products with
flexibility, as appropriate, to employ advances in science and
technology as they become available, without diminishing public health
protections.

DATES: This rule is effective May 13, 2011.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 30, 2010 (75 FR 15639), FDA
published a proposed rule to amend the regulations for constituent
materials under Sec.  610.15 (21 CFR 610.15). Constituent materials
include ingredients, preservatives, diluents, adjuvants, extraneous
protein and antibiotics that are contained in a biological product. FDA
is amending the regulation for constituent materials to allow the
Director of CBER or the Director of CDER, as appropriate, to approve an
exception or alternative to the requirements under Sec.  610.15. An
exception or alternative will be considered for approval when the data
submitted in support of such a request establish the safety, purity,
and potency of the biological product for the conditions for which the
applicant is seeking approval. Under the final rule, the Director of
CBER or CDER would not approve an exception or alternative when the
data or the conditions of use, including indication and patient
population, for which the applicant is seeking approval, do not provide
a sufficient scientific and regulatory basis for such an approval.
    The final rule provides manufacturers of biological products with
flexibility, as appropriate, to employ advances in science and
technology, as they become available. However, the final rule does not
diminish public health protections that are provided by existing laws
and regulations. The final rule gives manufacturers the potential to
employ advances in science and technology if the data provide a
sufficient regulatory basis for approval of the product. This means
that each manufacturer's request for an exception or alternative will
be considered on a case-by-case basis to determine whether the product
at issue meets the statutory and regulatory criteria for safety,
purity, and potency for use in the intended population. The Director of
CBER or CDER will only approve a request for an exception or
alternative after determining that the particular request meets this
prescribed criteria for the intended population. Examples of how the
final rule provides flexibility (such as alternatives to the use of
preservatives and modifications to the amount of aluminum permitted in
certain biological products), without diminishing public health
protections, are provided in the paragraphs that follow.\1\
---------------------------------------------------------------------------

    \1\ Although specific examples for use of extraneous protein and
antibiotics are not provided, the final rule also allows for
flexibility in applying the existing standards for extraneous
proteins and antibiotics (Sec.  610.15(b) and (c)); provided that
each request for an alternative or exception to these requirements
is supported by data that establish the safety, purity, and potency
of the biological product.
---------------------------------------------------------------------------

    Standards for certain constituent materials present in biological
products are provided under Sec.  610.15. Section 610.15(a) requires
that all ingredients used in a licensed product, and any diluent
provided as an aid in the administration of the product, meet generally
accepted standards of purity and quality. Any preservative used must be
sufficiently nontoxic so that the amount present in the recommended
dose of the product will not be toxic to the recipient, and in the
combination used, it must not denature the specific substances in the
product to result in a decrease below the minimum acceptable potency
within the dating period when stored at the recommended temperature.
Products in multiple-dose containers must contain a preservative,
except that a preservative need not be added to Yellow Fever Vaccine;
Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the
jet injector; dried vaccines when the accompanying diluent contains a
preservative; or to an allergenic product in 50 percent or more volume
in volume (v/v) glycerin. Furthermore, under Sec.  610.15, an adjuvant
must not be introduced into a product unless there is satisfactory
evidence that it does not affect adversely the safety or potency of the
product.
    Section 610.15(a) also requires that the amount of aluminum in the
recommended individual dose of a biological product not exceed:
    1. 0.85 milligrams if determined by assay;

    2. 1.14 milligrams if determined by calculation on the basis of the
amount of aluminum compound added; or
    3. 1.25 milligrams determined by assay provided that data
demonstrating that the amount of aluminum used is safe and necessary to
produce the intended effect are submitted to and approved by the
Director of CBER or the Director of CDER.
    Section 610.15 establishes standards for the presence of certain
constituent materials in licensed, biological products and/or strictly
limits the amount of certain constituent materials present in licensed
biological products. However, in order to employ advancements in
science and technology to benefit the public health, flexibility in
applying these regulatory standards is needed.
    For example, Sec.  610.15 contains specific requirements as to
preservatives. Preservatives are compounds that kill or prevent the
growth of micro-organisms, particularly bacteria and fungi. The current
requirements for preservatives were based, at least in part, on reports
from scientific literature concerning serious injuries and deaths
associated with bacterial contamination of multiple-dose containers of
vaccines that did not contain a preservative.\2\ As discussed
previously, Sec.  610.15 provides for limited exceptions from the
preservative requirement. These exceptions include live viral vaccines
that had been licensed under section 351 of the PHS Act (42 U.S.C. 262)
and that were in production when the National Institutes of Health
(NIH) issued the 1968 regulation.3 4
---------------------------------------------------------------------------

    \2\ See ``The National Vaccine Advisory Committee Sponsored
Workshop on Thimerosal Vaccines,'' pp. 21-25, August 11, 1999. See
also Wilson, Graham S., Hazards of Immunization, 1967.
    \3\ With the creation of NIH, NIH had regulatory authority over
biological products until 1972, at which time they were transferred
to FDA. NIH issued the precursor regulation to constituent
materials, Sec.  610.15, in the Federal Register of January 10, 1968
(33 FR 367 at 369). See the Federal Register notice of June 29, 1972
(37 FR 12865) and the Federal Register notice of August 9, 1972 (37
FR 15993), for more information concerning the transfer of authority
from NIH to FDA and how the regulations pertaining to biological
products under 21 CFR part 73 were transferred to the then newly
established 21 CFR part 273.
    \4\ Biological products had contained preservatives prior to
1968. ``The National Vaccine Advisory Committee Sponsored Workshop
on Thimerosal Vaccines,'' p. 24, August 11, 1999.
---------------------------------------------------------------------------

    Preservatives in multiple-dose containers have a long record of
safe and effective use in preventing microbial growth in the event that
the vaccine is accidentally contaminated, as might occur with repeated
punctures of a multiple-dose container. Even though the use of
preservatives has significantly declined in recent years with the use
of products filled in single-dose containers that do not require
addition of a preservative, some biological products such as
inactivated influenza virus vaccines are still presented in multi-dose
containers with a preservative. The use of preservatives could also
decline further as manufacturers develop and employ new technologies,
such as multi-dose adaptors to prevent contamination of products in
multiple-dose containers, without the use of preservative.
    However, the current regulation under Sec.  610.15(a) does not
provide FDA with flexibility to consider situations (outside of the
listed exceptions) in which to allow the use of preservative-free
vaccines in multiple-dose containers. It is necessary for FDA to have
flexibility in applying the regulatory requirements for preservatives
when, for example, state-of-the art technologies, such as the
development of devices to ensure aseptic withdrawing offer a safe
alternative to the use of preservatives in multiple-dose containers.
The final rule permits the Director of CBER or the Director of CDER to
approve a request to market a biological product in multiple-dose
containers without the use of a preservative, if the manufacturer
demonstrates that sufficient measures, such as an aseptic withdrawing
technique through the use of an appropriate device, ensure that the
product continues to meet the statutory and regulatory requirements for
safety, purity, and potency. Thus, the final rule allows flexibility in
the use of advancements in technology to provide a public benefit,
while continuing to ensure the safety, purity, and potency of the
product.
    Another example where it is necessary for FDA to have flexibility
in applying current regulatory requirements pertains to the amount of
aluminum permitted under Sec.  610.15(a) in the recommended single
human dose of a biological product. Aluminum, in the form of an
aluminum salt, is used as an adjuvant in certain biological products.
The existing regulation limits the amount of aluminum per dose to no
more than 0.85 milligrams (mg) if determined by assay or 1.14 mg if
determined by calculation on the basis of the amount of aluminum
compound added. In 1981, FDA amended Sec.  610.15(a) to increase the
permissible level of aluminum per dose to 1.25 mg both to make the
regulation consistent with World Health Organization standards,\5\ and
because it appeared that certain groups (such as renal dialysis
patients), who were understood to be at high risk of contracting
hepatitis, might require a higher dosage of the hepatitis B vaccine,
which would in turn, require amounts of aluminum as high as 1.25 mg per
dose. (See ``General Biological Products Standards; Aluminum in
Biological Products,'' 46 FR 51903, October 23, 1981. See also
``General Biological Products Standards for Aluminum in Biological
Products,'' 46 FR 23765, April 28, 1981).
---------------------------------------------------------------------------

    \5\ More specifically, the amendment permitted the use of up to
1.25 mg per dose of aluminum determined by assay provided that data
demonstrating that the amount of aluminum used is safe and necessary
to produce the intended effect are submitted to and approved by the
Director, Bureau of Biologics. ``General Biological Products
Standards; Aluminum in Biological Products,'' (46 FR 51903, October
23, 1981).
---------------------------------------------------------------------------

    The aluminum content per dose in the formulation of a licensed
biological product, as specified in Sec.  610.15(a), reflects the NIH
Minimum Requirements for Diphtheria Toxoid (1947) \6\ and Tetanus
Toxoid (1952).\7\ The final rule does not alter the existing
requirements regarding the amount of aluminum in a biological product.
Instead, in a change that is analogous to the one FDA issued in 1981,
involving the groups who were at high risk of contracting hepatitis,
the final rule allows either the Director of CBER or the Director of
CDER to approve an exception or alternative when the Director
determines that a biological product meets the requirements for safety,
purity, and potency for the conditions for which the applicant is
seeking approval, but contains an amount of aluminum that is higher
than currently permitted by Sec.  610.15. For example, the final rule
permits the Director of CBER or CDER to approve a manufacturer's
request for an exception to use a proposed therapeutic vaccine for
treating individuals with cancer, when the proposed vaccine contains
aluminum levels higher than currently allowed but still meets the
requirements of safety, purity, and potency.
---------------------------------------------------------------------------

    \6\ NIH, Minimum Requirements for Diphtheria Toxoid, 4th
Revision, 1947.
    \7\ NIH, Minimum Requirements for Tetanus Toxoid, 4th Revision,
1952.
---------------------------------------------------------------------------

II. Clarifications to the Preamble of the Proposed Rule

    FDA received comments on the rule from manufacturers, private and
public interest groups, and the general public. In response to comments
expressing concerns about the safety of a licensed product for which
FDA grants an exception or alternative to current regulations, FDA
emphasizes that a manufacturer's request for an exception or
alternative will not be approved unless the submitted data meet the

statutory and regulatory criteria for safety, purity, and potency for
use in the intended population. FDA also emphasizes that the product at
issue must be shown to be safe, pure, and potent for the conditions of
use, including proposed indication and patient population, for which
the applicant is seeking approval, in determining whether the product
may be approved. FDA further clarifies that consideration for approval
of a request will be done case-by-case and will be based on review of
the data submitted in support of a request.
    In addition, in response to comments, FDA clarifies that there is
both a need for FDA to have flexibility in applying the regulatory
standards in Sec.  610.15, and a need for manufacturers to have
flexibility in employing advancements in science and technology for
developing new safe, pure, and potent alternatives to current products.
FDA provides more discussion on the need for flexibility in the
responses to comments on the proposed rule.
    FDA considered all comments received in response to the proposed
rule and has determined that the proposed rule should be issued as a
final rule. Accordingly, FDA is issuing as a final rule the amendment
to Sec.  610.15 under paragraph (d) to permit the Director of CBER or
the Director of CDER, as appropriate, to approve an exception or
alternative to the regulatory requirements for constituent materials,
when the data submitted with the request for approval of an exception
or alternative establish the safety, purity, and potency of the
biological product, and is acceptable for use in the intended
population. All requirements under Sec.  610.15 remain in effect,
except those for which the Director approves an exception or
alternative. FDA approval of an exception or alternative will be done
case-by-case, based on the data submitted for a specific product.
Manufacturers seeking approval of an exception or alternative must
submit a request in writing. The request may be submitted as part of
the original biologics license application (BLA) or as an amendment to
the original, pending application or as a prior approval supplement to
an approved application.

III. Comments on the Proposed Rule

    FDA received 15 letters of comment on the proposed rule, not
including 1 duplicate letter from the same commenter. As stated
previously, these comments were received from manufacturers, private
and public interest groups, and the general public. Several of the
comments supported the proposed rule and several comments disagreed
with the proposed rule. Some of the comments on the proposed rule were
similar to or duplicates of other comments received, and have been
grouped together, where appropriate, to facilitate a uniform response.
    To make it easier to identify the comments and our corresponding
responses, the word ``Comment'' followed by a number is placed in
parentheses and is used to indicate a particular comment or set of
similar comments, as appropriate. The word ``Response'' in parentheses
precedes FDA's response to a comment. The order of comments and
responses, as listed, do not represent a value assigned to the comment
but is used for organizational purposes only.
    (Comment 1) Several comments supported the proposed rule. One such
comment praised the rule for broadening the potential capacity for
biologics manufacturers to provide medicines to the public without
compromising the high level expectation of demonstrating safety,
purity, and potency. Another comment supported the proposed rule for
providing a means to advance ``innovative science'' and applications of
use. Yet another comment expressed interest in seeing the ``reasonable
flexibility'' provided in the proposed rule extended to other
biopharmaceutical fields. Still another comment found the conditions
and recommendations in the proposed rule to be comprehensible and
useful.
    (Response) FDA acknowledges and appreciates the supportive
comments. As previously stated, the rule allows FDA the flexibility to
approve an exception or alternative to the constituent materials
regulation, without diminishing public health protections. As such, the
final rule provides patients safe access to important products
resulting from advances in science and technology. FDA continues to
review existing regulations and may propose modification of these
regulations as appropriate for public health and safety.
    (Comment 2) One comment requests clarification as to whether a
request for an exception or alternative to the requirements under Sec.
610.15 can be made earlier in clinical development rather than waiting
until submitting the original BLA.
    (Response) FDA clarifies that although a manufacturer may submit a
request for an exception or alternative early in the clinical
development of a biological product, FDA considers such a request to be
timely when the data intended to support the request establish the
safety, purity, and potency of the biological product for its intended
use. In developing data necessary to support a request for an exception
or alternative, manufacturers must comply with all applicable laws and
regulations, including the procedures and requirements for
investigational new drug applications (INDs) and BLAs under parts 312
and 601 (21 CFR parts 312 and 601). Only after FDA determines that the
biological product meets the statutory and regulatory criteria for
safety, purity, and potency, and is acceptable for use in the intended
population, may the Director of CBER or CDER approve a request for an
exception or alternative.
    However, FDA strongly encourages early communication from
manufacturers intending to submit a request for an exception or
alternative to the requirements under Sec.  610.15. This includes pre-
IND and IND communications by which manufacturers may seek FDA advice
concerning issues such as data needed to support the rationale for
testing a biological product in humans, the design of nonclinical
pharmacology, toxicology, and drug activity studies, initial
development plans for the biological product, and regulatory
requirements for demonstrating safety, purity, and potency. Early
communications between FDA and manufacturers, as described previously,
are intended to be advisory and are not to be interpreted as approval
of a request for an exception or alternative.
    (Comment 3) One comment requests agreement from FDA that sponsors
may administer multiple doses taken from individual preservative-free
multi-dose vials in clinical trials prior to licensure, as long as the
sponsor follows pre-approved aseptic procedures in defined time periods
to support this format as part of the original license application.
    (Response) FDA does not agree with the comment. The current
regulation for preservatives requires that products in multiple-dose
containers contain a preservative, with listed exceptions. The final
rule provides the Director of CBER or CDER with flexibility to approve
a request for an exception or alternative to this requirement. However,
FDA will consider each request for an exception or alternative on a
case-by-case basis and approval of such a request will be based on the
determination that the data submitted with the request establishes a
regulatory basis for approval. Sponsors seeking to investigate the use
of a new biological product in humans must follow the procedures and
requirements for investigational drugs under part 312. (See also
Response to Comment 4).

    (Comment 4) Several comments opposed the proposed rule because the
commenters understood the rule to give the Director of CBER or CDER
sole authority in the decisionmaking process to approve a request for
an exception or alternative. Another comment stated that the proposed
rule does not allow for a deliberative process for vaccine ingredient
changes. Other comments stated that the drug industry had too much
influence upon government agencies including FDA, and that all
decisions about additives should reside with many experts, in order to
avoid the potential of undue influence. One comment seeks greater
transparency from FDA and manufacturers for all aspects of biologics.
Another comment states that all changes to medicine, particularly those
``which are proscribed by some government entities, should be subject
to a public review.''
    (Response) FDA acknowledges and appreciates all comments on the
proposed rule. FDA agrees with comments supporting public review and
transparency. However, FDA disagrees with the comments opposing the
authority of the Director of CBER or CDER to approve a biologic
product. FDA also disagrees with the comments that the rule places the
decisionmaking process in the hands of one person, does not allow for a
deliberative process for vaccine ingredient changes, and that
manufacturers will have an undue influence in the approval process.
    Under the provisions of the PHS Act, and the Federal Food, Drug,
and Cosmetic Act (the FD&C Act), FDA has the authority to issue and
enforce regulations designed to ensure that biological products are
safe, pure, and potent. Through delegations of authority,\8\ the
Directors of CBER and CDER have been given the authority to approve
biological products. Thus, the Directors of CBER and CDER may approve a
biologic product determined to be safe, pure, and potent, based on
factors that include review of data, and in some cases, taking into
account recommendations and input from independent experts (e.g.,
advisory committees), input from interested parties, and public
comments.
---------------------------------------------------------------------------

    \8\ Delegations of authority give certain officials in CBER and
CDER the legal authority to take substantive actions and perform
certain functions of the Commissioner of Food and Drugs. Staff
Manual Guide 1410.702 available on the Internet at  http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm049563.htm (accessed October 22, 2010); ``Drug and Biological
Product Consolidation,'' (68 FR 38067, June 26, 2003).
---------------------------------------------------------------------------

    The PHS Act and the FD&C Act provide FDA with the authority to
issue regulations that not only establish the requirements for product
approvals but also establish the requirements for clinical
investigations of unapproved biologics (21 U.S.C. 355(i) and 42 U.S.C.
262(a)(2)(A)). In accordance with part 312, manufacturers seeking to
investigate the use of a new biological product in humans must follow
specified procedures and requirements for investigational biological
products. During the IND process, manufacturers must submit, for FDA
review, data and proposals for additional studies intended to support
the safety, purity, and potency of a biological product. Manufacturers
also are required to provide information on patient outcomes and
adverse events observed during this investigation. FDA reviews the
submitted data and, upon determining that the biological product does
not represent an unreasonable risk to the safety of the persons who are
the subjects of the clinical investigation, will allow a manufacturer
to proceed with the investigational use of a biological product. A
manufacturer, after developing data to support approval, may submit a
BLA to FDA for review and approval.
    Under Sec.  601.2, the Director of CBER or CDER may approve a
manufacturer's application for a biologics license only after a
manufacturer submits an application accompanied by data derived from
nonclinical laboratory and clinical studies that demonstrate that the
manufactured product meets requirements of safety, purity, and potency.
These data are reviewed by appropriate experts to determine whether the
application meets the statutory and regulatory requirements. In
addition to the recommendations made by these experts, the Director of
CBER or CDER may seek input from other sources within and outside of
FDA to determine whether the application should be approved. Further,
FDA closely monitors the safety of a biological product during its pre-
approval and post-approval development, and may take corrective action,
as necessary to protect the public.
    In addition to the review process described previously, a sponsor,
applicant, or manufacturer of a biological product regulated under the
PHS Act (42 U.S.C. 262), may request review of a scientific controversy
by an appropriate scientific advisory panel (Sec.  10.75(b)(2) (21 CFR
10.75(b)(2)). Also, under Sec.  10.75(c), interested persons outside of
FDA may request internal review of a decision through established FDA
channels of supervision or review.
    Thus, the current regulations establish procedures for review and
evaluation of biological products, which include review by appropriate
internal and external experts. In addition, the current regulations
allow for public and private entities to participate in FDA's review
process, as appropriate. This process serves to increase transparency
and helps ensure that the public health is protected. The final rule
maintains these important regulatory procedures and requirements while
increasing FDA's flexibility in employing advances in science and
technology.
    (Comment 5) Several comments opposed the proposed rule because the
commenters believe the rule would make the use of vaccines less safe.
One commenter stated that FDA is ignoring its mandate to make vaccines
safer by any and all means at its disposal; that FDA is making vaccines
less safe by removing the certainty as to the minimum standards that a
biological product must meet; and that the proposed rule does not
require that the written requests for such exemptions or alternatives
include the appropriate proofs (toxicological and immunological) of the
short-term and long-term safety to the most susceptible humans. A few
comments stated that an increase in the amount of aluminum may
compromise the safety of vaccines. Another comment stated that families
do not feel that the current regulations are ``too prescriptive and
unnecessarily restrictive,'' and that families would prefer more
stringent rules. Other comments discussed specific concerns with
already-approved vaccines.
    (Response) FDA acknowledges these comments, as many of the issues
were considered in drafting the proposed rule. However, FDA disagrees
with the assertion that the rule will result in a decrease in the
safety of vaccines and other biological products for which a request
for an exception or alternative to any requirement under Sec.  610.15
is made and approved. These regulations will continue to be the
criteria by which all license applications will be evaluated. However,
in order to employ advancements in treatment for certain populations,
such as treatment for individuals suffering from life-threatening
conditions (e.g., cancer), FDA needs flexibility in applying the
regulations. By analogy, as is stated in the drug regulations at 21 CFR
314.105(c):

    While the statutory standards apply to all drugs, the many kinds
of drugs that are subject to statutory standards, and the wide range
of uses for those drugs demand flexibility in applying the
standards. Thus FDA is required to exercise its scientific judgment
to determine the kind and quantity of data and information an
applicant is

required to provide for a particular drug to meet the statutory
standards.

The final rule is consistent with this CDER regulation as it allows the
Directors of CBER and CDER flexibility in applying current standards
for the approval of an exception or alternative to Sec.  610.15, when
data submitted with the request for an exception or alternative,
establish the safety, purity, and potency of the biological product.
    Further, consistent with existing statutory and regulatory
requirements, the Directors of CBER and CDER will not approve a
biological product that is unsafe for the intended population. The
final rule does not alter these statutory and regulatory requirements
nor does it guarantee that a request for an exception or alternative
will be approved. The final rule only allows the Director of CBER or
CDER the flexibility to approve a manufacturer's request for an
exception or alternative if the manufacturer demonstrates that the
biological product is safe, pure, and potent for use in the intended
population.
    With regard to comments expressing concern about the safety of
previously licensed vaccines or specific ingredients in previously
licensed vaccines, FDA notes that those comments concerning previously
licensed vaccines are outside the scope of this rulemaking action
because the rule only allows the Director of CBER or CDER to approve a
manufacturer's request for an exception or alternative to any
requirement in Sec.  610.15, when the data submitted in support of such
a request establish the safety, purity, and potency of the biological
product.
    (Comment 6) One comment opposed the proposed rule because the
commenter did not know how FDA would monitor or enforce requirements
for adequate storage, aseptic withdrawing techniques, and timely use of
vaccines in multiple-dose containers without preservative or if
additional training would be given to health care providers.
    (Response) In addressing this comment, FDA clarifies that all
requests for an exception or alternative are subject to FDA regulations
regarding the monitoring and enforcement of regulatory standards. These
regulations were established to assure the quality and integrity of
data submitted to FDA in support of new product approvals and to
protect the rights and welfare of the public. FDA accomplishes this
through various means, including conducting onsite inspections, data
audits, product testing, and report monitoring. FDA also provides
advice through guidances and other communications which are provided to
assist interested parties in complying with regulatory standards for
the safety, purity, and potency of a product.
    (Comment 7) One comment provided alternative revisions to the
proposed rule and other subsections within Sec.  610.15. Specifically,
the commenter proposed that FDA revise the proposed rule to read as
follows:

    Alternatives. Except for the generally accepted standards of
purity and quality, in keeping with the vaccine safening mandates
set forth in 42 U.S.C. 300aa-27''; * * * ``the Director of the
Center for Biologics Evaluation and Research or the Director of the
Center for Drug Evaluation and Research may approve an exception or
alternative to any requirement in this section, provided the
manufacturer proves that the exception or alternative would improve
the safety of the biological drug product or, failing that, improves
the effectiveness, not efficacy, or reduces the per dose cost, of
the biological drug product without reducing the safety of said
product''; and * * * ``include the findings, pro and con, of and the
data from all of the studies conducted to support the request.

    (Response) FDA acknowledges the comment and appreciates the
suggestions for revising Sec.  610.15. However, in accordance with the
regulations, FDA is seeking public comment only on the proposed rule to
permit the Director of CBER or the Director of CDER, as appropriate, to
approve exceptions or alternatives to the regulation for constituent
materials. FDA's response to the comments requesting revisions to the
proposed rule are discussed in the paragraphs that follow.
    FDA disagrees with the commenter's suggested revisions to the
proposed rule because the revisions inappropriately limit the
application of the rule to vaccines; allow more flexibility than is
intended for approving a manufacturer's request for an exception or
alternative; may lead to confusion about the rule; and are unnecessary.
As discussed previously, the final rule allows the Director of CBER or
CDER flexibility to approve a request for an exception or alternative
to a requirement under Sec.  610.15 provided that data are submitted
that establish the safety, purity, and potency of the specific
biological product. These statutory and regulatory requirements apply
to the use of constituent materials in all biological products and not
just to vaccines as the comment suggests. In addition, FDA may only
approve a BLA for a vaccine or other biological product if it has been
demonstrated to be ``safe, pure, and potent.'' The commenter's
suggestions that FDA should take cost considerations into account when
making a decision to approve a vaccine are inconsistent with FDA's
regulatory authority. Although FDA is sensitive to issues of cost,
current statutory standards for constituent materials are based on the
safety, purity, and potency of the product. Furthermore, the suggested
revisions to the proposed rule inappropriately limit what FDA may
consider with respect to a request for an exception or alternative.
Manufacturers are required by current regulations to submit all
available data, including adverse event reports, with a BLA. FDA
reviews the data to determine whether an application should be
approved. The final rule, as consistent with current regulations, does
not allow the Director of CBER or CDER to approve an application if the
data are not sufficient to establish that the biological product is
safe, pure, and potent in relation to the manufacturer's intended use
of the product.

IV. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and
general administrative provisions of the FD&C Act (sections 201, 301,
501, 502, 503, 505, 510, 701, and 704) (21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 371, and 374). Under these provisions of the PHS Act and
the FD&C Act, we have the authority to issue and enforce regulations
designed to ensure that biological products are safe, pure, and potent;
and prevent the introduction, transmission, and spread of communicable
disease.

V. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies 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). The Agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory

options that would minimize any significant impact of a rule on small
entities. Because the final rule allows the Director of CBER or the
Director of CDER, as appropriate, to approve exceptions or alternatives
to the regulations for constituent materials, this action increases the
flexibility and reduces the regulatory burden for affected entities.
Therefore, FDA certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``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 $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The benefit of this regulatory action is its reduction, through
greater flexibility in the regulatory requirements, of burdens on the
biological products industry. These issues are discussed in greater
detail in section I of this document. Industry cost reductions may
result in consumers being offered lower prices or wider availability of
existing and new biological products; this would have a positive effect
on patients' welfare.
    Any administrative and paperwork costs associated with this
regulatory action are expected to be minimal and widely dispersed among
affected entities. Based on FDA experience, we estimate that we would
receive a total of approximately three requests annually for an
exception or alternative under Sec.  610.15. FDA experience with
similar information collection requirements suggests that approximately
1 hour would be required to prepare and submit each such request.
    We received comments expressing concern that this rule would
generate additional costs in the form of negative public health
effects. FDA has considered the potential for adverse consequences,
including increased morbidity and mortality, associated with allowing
deviations from the constituent materials regulations set forth in
Sec.  610.15(a) through (c), and will grant exemptions only in cases
where data indicate that biological products in their exempted forms
will be safe, pure, and potent for the conditions for which the
applicant is seeking approval. As experience with the October 1981 rule
has shown, FDA is able to conduct a constituent materials exemption
process in a manner that is consistent with its public health mandate.
For all these reasons, we believe the final rule will impose no overall
public health cost.

B. Environmental Impact

    The Agency has determined under 21 CFR 25.31(h) that this action is
of a type that does not individually or cumulatively have a significant
adverse effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

C. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the final
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, the Agency has concluded
that the final 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.

VI. Paperwork Reduction Act of 1995

    Section 610.15(d) of this final rule contains reporting
requirements that were submitted for review and approval to the
Director of the Office of Management and Budget (OMB), as required by
section 3507(d) of the Paperwork Reduction Act of 1995. The
requirements were approved and assigned OMB control number 0910-0666.

List of Subjects in 21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 610 is amended as follows:

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
1. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

0
2. Amend Sec.  610.15 by adding paragraph (d) to read as follows:

Sec.  610.15  Constituent materials.

* * * * *
    (d) The Director of the Center for Biologics Evaluation and
Research or the Director of the Center for Drug Evaluation and Research
may approve an exception or alternative to any requirement in this
section. Requests for such exceptions or alternatives must be in
writing.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8885 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Page 46287]
[FR Doc No: 2011-19468]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 2047-049]

Erie Boulevard Hydropower, L.P.; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC)
regulations, 18 CFR Part 380, Commission staff has reviewed the
application for amendment of license for the Stewarts Bridge Project
(FERC No. 2047) and has prepared an environmental assessment (EA). The
project is located on the Sacandaga River in Saratoga County, New York.
    The EA contains the Commission staff's analysis of the potential
environmental effects of the proposed addition of new generating
capacity and concludes that authorizing the amendment, with appropriate
environmental protective measures would not constitute a major Federal
action that would significantly affect the quality of the human
environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site 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. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY
contact<PHONE_NUMBER>.

    Dated: July 26, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-19468 Filed 8-1-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41362]
[DOCID:fr18jy08-95]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Animal Models for the Treatment of Acute Radiation Syndrome;
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research and Center for Drug Evaluation and Research,
and the National Institutes of Health, National Institute of Allergy
and Infectious Diseases, are announcing a public workshop entitled
``Animal Models for the Treatment of Acute Radiation Syndrome (ARS).''
The purpose of the public workshop is to discuss issues that should be
considered when developing animal models to assist in developing and
demonstrating the efficacy of products intended for treatment of ARS.
    Date and Time: The public workshop will be held on September 17,
2008, from 8:30 a.m. to 5:30 p.m., and on September 18, 2008, from 8:30
a.m. to 1 p.m.
    Location: The public workshop will be held at the Hilton Hotel,
Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD
20877.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation
and Research (HFM-43), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX: 301-827-
3079; e-mail<EMAIL_ADDRESS>(Subject line: Animal Models for
ARS Workshop).
    Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to the contact person by August 25, 2008. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 8 a.m. If you need
special accommodations due to a disability, please contact Bernadette
Kawaley (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:  There are no approved medical products with
an indication for treatment of ARS. The public workshop will provide
the opportunity to explore current research involving animal models for
the development of treatments for ARS, and to determine what areas need
further research. There will be feature presentations by experts from
government, academia, and medicine. The first day of the workshop will
include presentations on the effects of radiation and the management of
patients with ARS, and a discussion of the application of the animal
rule to therapies for ARS. Both days of the workshop will examine the
challenges faced when using animal models to mimic radiation exposure
scenarios and will include panel discussions that will focus on various
animal models and their application to the different syndromes of ARS.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16461 Filed 7-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Rules and Regulations]
[Pages 36320-36322]
[FR Doc No: 2017-16414]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2017-0317; Special Conditions No. 25-694-SC]

Special Conditions: Embraer S.A. Model ERJ 190-300 Airplane;
Flight Envelope Protection: Normal Load Factor (g) Limiting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Embraer S.A.
(Embraer) Model ERJ 190-300 airplane. This airplane will have a novel
or unusual design feature when compared to the state of technology
envisioned in the airworthiness standards for transport-category
airplanes. This design feature involves flight-envelope protection
functions that limit such flight parameters as, for example, angle of
attack, normal load factor, attitude, bank angle, and speed during
normal operation. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: This action is effective on Embraer S.A. on August 4, 2017. We
must receive your comments by September 18, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0317
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478).
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and Flight
Crew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been subject to the notice and comment period in several prior
instances and has been derived without substantive change from those
previously issued. It is unlikely that prior public comment would
result in a significant change from the substance contained herein.
Therefore, because a delay would significantly affect the certification
of the airplane, the FAA has determined that prior public notice and
comment are unnecessary and impracticable.
    In addition, since the substance of these special conditions has
been subject to the public comment process in several prior instances
with no substantive comments received, the FAA finds it unnecessary to
delay the effective date and finds that good cause exists for adopting
these special conditions upon publication in the Federal Register.

    The FAA is requesting comments to allow interested persons to
submit views that may not have been submitted in response to the prior
opportunities for comment described above.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On September 13, 2013, Embraer applied for an amendment to Type
Certificate No. A57NM to include the new Model ERJ 190-300 airplane.
The Model ERJ 190-300 airplane, which is a derivative of the Embraer
Model ERJ 190-100 STD airplane currently approved under Type
Certificate No. A57NM, is a 97- to 114-passenger transport-category
airplane. The maximum take-off weight is 124,340 lbs (56,400 kg).

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane
meets the applicable provisions of the regulations listed in Type
Certificate No. A57NM, or the applicable regulations in effect on the
date of application for the change, except for earlier amendments as
agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model ERJ 190-300 airplane because
of a novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model ERJ 190-300 airplane must comply with the fuel-
vent and exhaust-emission requirements of 14 CFR part 34 and the noise-
certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Embraer Model ERJ 190-300 airplane will incorporate the
following novel or unusual design feature: Flight-envelope protection
functions that limit such flight parameters as, for example, angle of
attack, normal load factor, attitude, bank angle, and speed during
normal operation.
    The Model ERJ 190-300 airplane incorporates normal load-factor
limiting on a full-time basis, which prevents the pilot from exceeding
the positive or negative airplane limit load factor. The application of
this load-factor limiting function affects airplane-handling
characteristics and may compromise the airplane's maneuverability and
controllability. The current regulations do not contain adequate safety
standards for these novel protection features.

Discussion

    The Embraer Model ERJ 190-300 design has a complex, fully digital
flight-control system, referred to as fly-by-wire (FBW) architecture.
This FBW architecture provides closed-loop flight-control laws and
multiple protection functions.
    Airplanes with conventional flight-control systems (mechanical
linkages) are limited in the pitch axis only by the elevator surface
area and deflection limit. The elevator-control power is normally
derived for adequate controllability and maneuverability at the most
critical longitudinal pitching moment. The result is that, for
traditional airplanes, maneuverability in excess of limit structural
design values, within a significant portion of the flight envelope, is
possible.
    Part 25 does not specify requirements or policy for demonstrating
maneuver control that imposes any handling-qualities requirements
beyond the design limit structural loads. Nevertheless, the
availability of this excess maneuver capacity, in the event of extreme
emergency such as upset recoveries or collision avoidance, is
recognized.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later
date for a change to the type certificate to include another model
incorporating the same novel or unusual design feature, these special
conditions would apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model of airplane. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Embraer Model ERJ 190-300 airplanes.
    1. Normal Load Factor (g) Limiting. To meet the intent of adequate
maneuverability and controllability required by Sec.  25.143(a); and in
addition to the requirements of Sec.  25.143(a), and in the absence of
other limiting factors, the following special conditions apply, based
on Sec.  25.333(b):
    a. The positive limiting load factor must not be less than:
    i. 2.5 g for the normal state of the electronic flight-control
system with the high-lift devices retracted up to VMO/
MMO. The positive limiting load factor may gradually be
reduced to 2.25 g above VMO/MMO.
    ii. 2.0 g for the normal state of the electronic flight-control
system with the high-lift devices extended.
    b. The negative limiting load factor must be equal to or more
negative than:
    i. Minus 1.0 g for the normal state of the electronic flight-
control system with the high-lift devices retracted.
    ii. 0.0 g for the normal state of the electronic flight-control
system with high-lift devices extended
    c. Maximum reachable positive load factor, wings level, may be
limited by the characteristics of the electronic

flight-control system or flight-envelope protections (other than load-
factor protection), provided that:
    i. The required values are readily achievable in turns, and
    ii. Wings-level pitch-up is satisfactory.
    d. Maximum achievable negative load factor may be limited by the
characteristics of the electronic flight-control system or flight-
envelope protections (other than load-factor protection), provided
that:
    i. Pitch-down responsiveness is satisfactory, and
    ii. From level flight, 0g is readily achievable, or alternatively,
a satisfactory trajectory change is readily achievable at operational
speeds. For the FAA to consider a trajectory change as satisfactory,
the applicant should propose and justify a pitch rate that provides
sufficient maneuvering capability in the most critical scenarios.
    e. Compliance demonstration with the above requirements may be
performed without ice accretion on the airframe.
    f. These special conditions do not impose an upper bound for the
normal load-factor limit, nor do they require that the limiter exist.
If the limit is set at a value beyond the structural design limit
maneuvering load factor n of Sec. Sec.  25.333(b), 25.337(b), and
25.337(c), then there should be a very obvious positive tactile feel
built into the controller so that it serves as a deterrent to
inadvertently exceeding the structural limit.

    Issued in Renton, Washington.
Victor Wicklund,
Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16414 Filed 8-3-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Page 46359]
[FR Doc No: 2011-19456]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Announcing the Nineteenth Public Meeting of the Crash Injury
Research and Engineering Network (CIREN)

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Meeting announcement.

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SUMMARY: This notice announces the Nineteenth Public Meeting of members
of the Crash Injury Research and Engineering Network. CIREN is a
collaborative effort to conduct research on crashes and injuries at six
Level I Trauma Centers across the United States linked by a computer
network. The current CIREN model utilizes two types of centers, medical
and engineering. Medical centers are based at Level I Trauma Centers
that admit large numbers of people injured in motor vehicle crashes.
These teams are led by trauma surgeons and emergency physicians and
also include a crash investigator and project coordinator. Engineering
centers are based at academic engineering laboratories that have
experience in motor vehicle crash and human injury research.
Engineering teams partner with trauma centers to enroll crash victims
into the CIREN program. Engineering teams are led by mechanical
engineers, typically trained in the area of impact biomechanics.
Engineering teams also include trauma/emergency physicians, a crash
investigator, and a project coordinator. Either type of team typically
includes additional physicians and/or engineers, epidemiologists,
nurses, and other researchers. The CIREN process combines prospective
data collection with professional multidisciplinary analysis of medical
and engineering evidence to determine injury causation in every crash
investigation conducted. Researchers can review data and share
expertise, which may lead to a better understanding of crash injury
mechanisms and the design of safer vehicles.
    The six centers will give presentations on current research based
on CIREN data. Topics include side air bag analysis utilizing CIREN
weighted data; the role of frailty in crash related injuries;
fatalities and serious injuries in multiple event rollover crashes;
validation of prehospital trauma triage: mechanism of injury; small
overlap frontal crashes and injury causation; and brain injury
analysis. The final agenda will be posted to the CIREN Web site that
can be accessed by going to the NHTSA homepage http://www.nhtsa.dot.gov/, click on Vehicle Safety Research on the right side
of the top toolbar, then click on Crash Injury Research and Engineering
Network (CIREN) in the box on the left. The agenda will be posted one
week prior to the meeting.

DATES AND TIME: The meeting is scheduled from 9 a.m. to 4 p.m. on
Wednesday, September 7, 2011.

ADDRESSES: The meeting will be held at: Department of Transportation
Headquarters, Oklahoma Room, 1200 New Jersey Avenue, SE., Washington,
DC 20590.
    To Register for this Event: It is essential that you pre-register
to expedite the security process for entry to the meeting facility.
Please send your name, affiliation, phone number, and e-mail address to
<EMAIL_ADDRESS>by Thursday, September 1, 2011, in order to have
your name added to the pre-registration list. Everyone must have a
government-issued photo identification to be admitted to the facility.
    For General Information: Rodney Rudd<PHONE_NUMBER>, Mark Scarboro
(202) 366-5078 or Cathy McCullough<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NHTSA has held CIREN public meetings on a
regular basis since 2000, including quarterly meetings and annual
conferences. This is the nineteenth such meeting. Presentations from
these meetings are available through the NHTSA Web site. NHTSA plans to
continue holding CIREN meetings on a regular basis to disseminate CIREN
information to interested parties. Individual CIREN cases collected
since 1998 may be viewed from the NHTSA/CIREN Web site at the address
provided above. Should it be necessary to cancel the meeting due to
inclement weather or to any other emergencies, a decision to cancel
will be made as soon as possible and posted immediately on CIREN's Web
site as indicated above. If you do not have access to the Web site, you
may call or e-mail the contacts listed in this announcement and leave
your telephone number or e-mail address. You will be contacted only if
the meeting is postponed or canceled.

    Issued on: July 27, 2011.
John Maddox,
Associate Administrator for Vehicle Safety Research.
[FR Doc. 2011-19456 Filed 8-1-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29780-29781]
[FR Doc No: 2020-10616]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-22]

Petition for Exemption; Summary of Petition Received; Aero Seat,
Inc.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before May 26, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0403
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records

notice (DOT/ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Justin Barcas<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 13, 2020.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0403.
    Petitioner: Aero Seat, Inc.
    Section(s) of 14 CFR Affected: Sec. Sec.  135.293, 135.299.
    Description of Relief Sought: Aero Seat, Inc. requests relief from
the testing and checking requirements in part 135 that would allow its
pilot to continue operating until December 2020 based on the competency
and line checks completed in December 2018. Aero Seat, Inc. cites a
lack of qualified FAA inspectors available to conduct the testing and
checking and difficulties imposed by the COVID-19 crisis as
justification for an exemption.

[FR Doc. 2020-10616 Filed 5-15-20; 8:45 am]
BILLING CODE 4910-13-P