[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Proposed Rules]
[Pages 50647-50648]
[FR Doc No: 2012-20656]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1435; Airspace Docket No. 11-ACE-28]

Proposed Amendment of Class E Airspace; Perry, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Perry, IA.
Decommissioning of the Perry non-directional beacon (NDB) at Perry
Municipal Airport, Perry, IA, has made reconfiguration necessary for
standard instrument approach procedures and for the safety and
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Comments must be received on or before October 9, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2011-1435/Airspace Docket No. 11-
ACE-28, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall

regulatory, aeronautical, economic, environmental, and energy-related
aspects of the proposal. Communications should identify both docket
numbers and be submitted in triplicate to the address listed above.
Commenters wishing the FAA to acknowledge receipt of their comments on
this notice must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-1435/Airspace Docket No. 11-ACE-28.'' The postcard will be
date/time stamped and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by modifying Class E airspace extending upward from
700 feet above the surface for new standard instrument approach
procedures at Perry Municipal Airport, Perry, IA. Airspace
reconfiguration is necessary due to the decommissioning of the Perry
NDB and the cancellation of the NDB approach. Controlled airspace is
necessary for the safety and management of IFR operations at the
airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9V, dated August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Perry Municipal Airport,
Perry, IA.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, dated August 9,
2011, and effective September 15, 2011, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

ACE IA E5 Perry, IA [Amended]

Perry Municipal Airport, IA
    (Lat. 41[deg]49'41'' N., long. 94[deg]09'35'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Perry Municipal Airport.

    Issued in Fort Worth, TX on August 1, 2012.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-20656 Filed 8-21-12; 8:45 am]
BILLING CODE 4901-13-P


                EPA ICR No. 1710.08; OMB Control No. 2070-0151

                                 ATTACHMENT 1

           Residential Lead-Based Paint Hazard Reduction Act of 1992

                                 42 USC 4852d

                    TITLE 42--THE PUBLIC HEALTH AND WELFARE

          CHAPTER 63A--RESIDENTIAL LEAD-BASED PAINT HAZARD REDUCTION

                SUBCHAPTER I--LEAD-BASED PAINT HAZARD REDUCTION

Sec. 4852d. Disclosure of information concerning lead upon transfer of residential property

(a) Lead disclosure in purchase and sale or lease of target housing

           (1) Lead-based paint hazards

    Not later than 2 years after October 28, 1992, the Secretary and the Administrator of the Environmental Protection Agency shall promulgate regulations under this section for the disclosure of lead-based paint hazards in target housing which is offered for sale or lease. The regulations shall require that, before the purchaser or lessee is obligated under any contract to purchase or lease the housing, the seller or lessor shall--
        (A) provide the purchaser or lessee with a lead hazard information pamphlet, as prescribed
    by the Administrator of the Environmental Protection Agency under section 406 of the Toxic
    Substances Control Act [15 U.S.C. 2686];
        (B) disclose to the purchaser or lessee the presence of any known lead-based paint, or any
    known lead-based paint hazards, in such housing and provide to the purchaser or lessee any
    lead hazard evaluation report available to the seller or lessor; and
        (C) permit the purchaser a 10-day period (unless the parties mutually agree upon a different
    period of time) to conduct a risk assessment or inspection for the presence of lead-based
    paint hazards.

             (2) Contract for purchase and sale

    Regulations promulgated under this section shall provide that every contract for the purchase and sale of any interest in target housing shall contain a Lead Warning Statement and a statement
signed by the purchaser that the purchaser has--
        (A) read the Lead Warning Statement and understands its contents;
        (B) received a lead hazard information pamphlet; and
        (C) had a 10-day opportunity (unless the parties mutually agreed upon a different period of
    time) before becoming obligated under the contract to purchase the housing to conduct
    a risk assessment or inspection for the presence of lead-based paint hazards.

           (3) Contents of lead warning statement

    The Lead Warning Statement shall contain the following text printed in large type on a separate sheet of paper attached to the contract:

    ``Every purchaser of any interest in residential real property on which a residential dwelling was built prior to 1978 is notified that such property may present exposure to lead from lead-based paint that may place young children at risk of developing lead poisoning. Lead poisoning in young children may produce permanent neurological damage, including learning disabilities, reduced intelligence quotient, behavioral problems, and impaired memory. Lead poisoning also poses a particular risk to pregnant women. The seller of any interest in residential real property is required to provide the buyer with any information on lead-based paint hazards from risk assessments or inspections in the seller's possession and notify the buyer of any known  lead-based paint hazards. A risk assessment or inspection for possible lead-based paint hazards   is recommended prior to purchase.''.

           (4) Compliance assurance

    Whenever a seller or lessor has entered into a contract with an agent for the purpose of selling or leasing a unit of target housing, the regulations promulgated under this section shall require the agent, on behalf of the seller or lessor, to ensure compliance with the requirements of this section.

           (5) Promulgation

    A suit may be brought against the Secretary of Housing and Urban Development and the Administrator of the Environmental Protection Agency under section 20 of the Toxic Substances Control Act [15 U.S.C. 2619] to compel promulgation of the regulations required under this section and the Federal district court shall have jurisdiction to order such promulgation.

(b) Penalties for violations

           (1) Monetary penalty

    Any person who knowingly violates any provision of this section shall be subject to civil money penalties in accordance with the provisions of section 3545 of this title.

           (2) Action by Secretary

    The Secretary is authorized to take such lawful action as may be necessary to enjoin any violation of this section.

           (3) Civil liability

    Any person who knowingly violates the provisions of this section shall be jointly and severally liable to the purchaser or lessee in an amount equal to 3 times the amount of damages incurred by such individual.           (4) Costs

        In any civil action brought for damages pursuant to paragraph (3), the appropriate court may award court costs to the party commencing such action, together with reasonable attorney fees and any expert witness fees, if that party prevails.

          (5) Prohibited act

    It shall be a prohibited act under section 409 of the Toxic Substances Control Act [15 U.S.C. 2689] for any person to fail or refuse to comply with a provision of this section or with any rule or order issued under this section. For purposes of enforcing this section under the Toxic Substances Control Act [15 U.S.C. 2601 et seq.], the penalty for each violation applicable under section 16 of that Act [15 U.S.C. 2615] shall not be more than $10,000.

(c) Validity of contracts and liens

    Nothing in this section shall affect the validity or enforceability of any sale or contract for the purchase and sale or lease of any interest in residential real property or any loan, loan agreement, mortgage, or lien made or arising in connection with a mortgage loan, nor shall anything in this section create a defect in title.

(d) Effective date

    The regulations under this section shall take effect 3 years after October 28, 1992.

(Pub. L. 102-550, title X, Sec. 1018, Oct. 28, 1992, 106 Stat. 3910.)

           References in Text

    The Toxic Substances Control Act, referred to in subsec. (b)(5), is Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 2601 of Title 15 and Tables.

           Section Referred to in Other Sections

    This section is referred to in section 4856 of this title; title 15 section 2686.


[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 921-922]
[FR Doc No: 2020-00070]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3592]

Certificates of Confidentiality; Guidance for Sponsors, Sponsor-
Investigators, Researchers, Industry, and Food and Drug Administration
Staff; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending
the comment period for the notice entitled ``Certificates of
Confidentiality; Guidance for Sponsors, Sponsor-Investigators,
Researchers, Industry, and Food and Drug Administration Staff;
Availability'' that appeared in the Federal Register of November 25,
2019. The Agency is taking this action to allow interested persons
additional time to submit comments before finalization of the guidance.

DATES: FDA is extending the comment period on the notice published
November 25, 2019 (84 FR 64906). Submit either electronic or written
comments on the draft guidance by January 24, 2020, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3592 for ``Certificates of Confidentiality; Guidance for
Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and
Drug Administration Staff.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://

www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Office of Policy, Bldg. 32, Rm. 4248, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 25, 2019 (84 FR 64906), FDA
published a notice with a 45-day comment period to request comments on
the draft guidance for industry and staff entitled ``Certificates of
Confidentiality; Guidance for Sponsors, Sponsor-Investigators,
Researchers, Industry, and Food and Drug Administration Staff.'' FDA is
extending the comment period, in response to a request from a
stakeholder, until January 24, 2020. The Agency believes the extension
allows adequate time for interested persons to submit comments without
significantly delaying publication of the final version of the
guidance.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00070 Filed 1-7-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16270-16272]
[FR Doc No: 2019-07764]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1517]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Abbreviated New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
abbreviated new animal drug applications.

DATES: Submit either electronic or written comments on the collection
of information by June 17, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 17, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1517 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Abbreviated New Animal Drug
Applications. '' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the

``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Abbreviated New Animal Drug Applications--Sections 512(b)(2) and (n)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))

OMB Control Number 0910-0669--Extension

    Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), any person may file an abbreviated new animal drug
application (ANADA) seeking approval of a generic copy of an approved
new animal drug. The information required to be submitted as part of an
ANADA is described in section 512(n)(1) of the FD&C Act. Among other
things, an ANADA is required to contain information to show that the
proposed generic drug is bioequivalent to, and has the same labeling
as, the approved new animal drug. We allow applicants to submit a
complete ANADA or to submit information in support of an ANADA for
phased review. Applicants may submit Form FDA 356v with a complete
ANADA or a phased- review submission to ensure efficient and accurate
processing of information. We use the information submitted, among
other things, to assess bioequivalence to the originally approved drug
and thus, the safety and effectiveness of the generic new animal drug.
    We believe the demonstration of bioequivalence required by the
statute does not need to be established on the basis of in vivo studies
(blood level bioequivalence or clinical endpoint bioequivalence) for
soluble powder oral dosage form products and certain Type A medicated
articles. We are adding to this information collection applicant
requests to waive the requirement to establish bioequivalence through
in vivo studies (biowaiver requests) for soluble powder oral dosage
form products or certain Type A medicated articles based upon either of
two methods. We will consider granting a biowaiver request if it can be
shown that the generic soluble powder oral dosage form product or Type
A medicated article contains the same active and inactive ingredient(s)
and is produced using the same manufacturing processes as the approved
comparator product or article. Alternatively, we will consider granting
a biowaiver request without direct comparison to the pioneer product's
formulation and manufacturing process if it can be shown that the
active pharmaceutical ingredient(s) (API) is the same as the pioneer
product, is soluble, and that there are no ingredients in the
formulation likely to cause adverse pharmacologic effects. We use the
information submitted by applicants in the biowaiver request as the
basis for our decision whether to grant the request.
    Additionally, we have found that various uses of veterinary master
files have increased the efficiency of the drug development and drug
review processes for both us and the animal pharmaceutical industry. A
veterinary master file is a repository for submission to FDA's Center
for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more veterinary drugs.
Veterinary master files are used by the animal pharmaceutical industry
in support of information being submitted for new animal drug
applications (NADAs), ANADAs, investigational new animal drug (INAD)
files, and generic investigational new animal drug (JINAD) files. In
previous information collection requests, we included the time
necessary to compile and submit such information to veterinary master
files within the burden estimates provided for applications and amended
applications (for NADAs and INAD files) and abbreviated applications
and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We recently combined the time necessary to compile and
submit such information to veterinary master files within the burden
estimates provided in the collection of information supporting new
animal drug applications (OMB control number 0910-0032).
    The reporting associated with ANADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(2) of the FD&C Act. As noted, we use the information
submitted, among other things, to assess bioequivalence to the
originally approved drug and thus, the safety and effectiveness of the
generic new animal drug.
    Description of Respondents: The respondents for this collection of
information are veterinary pharmaceutical manufacturers.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Activity                           FDA Form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA...................................................            356v              18               1              18             159           2,862
Phased Review with Administrative ANADA.................            356v               3               5              15            31.8             477
Biowaiver request for soluble powder oral dosage form                N/A               1               1               1               5               5
 product, using same formulation/manufacturing process
 approach...............................................
Biowaiver request for soluble powder oral dosage form                N/A               5               5               5              10              50
 product, using same API/solubility approach............
Biowaiver request for Type A medicated article, using                N/A               2               2               2               5              10
 same formulation/manufacturing process approach........
Biowaiver request for Type A medicated article, using                N/A              10              10              10              20             200
 same API/solubility approach...........................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............              51  ..............           3,604
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our records of generic drug applications.
We estimate that we will receive 21 ANADA submissions per year over the
next 3 years and that three of those submissions will request phased
review. We estimate that each applicant that uses the phased review
process will have approximately five phased reviews per application. We
estimate that an applicant will take approximately 159 hours to prepare
either an ANADA or the estimated five ANADA phased review submissions
and the administrative ANADA. Our estimates of the burden of biowaiver
requests for generic soluble powder oral dosage form products and Type
A medicated articles differ based on the type of product and the basis
for the request, as shown in table 1. We estimate that an applicant
will take between 5 and 20 hours to prepare a biowaiver request.
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our previous
estimate of the number of respondents submitting generic drug
applications. However, as discussed, the burden for this information
collection was increased by 265 hours and 18 responses since the last
OMB approval. This is due to adding to this collection burden hours and
responses for biowaiver requests.

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07764 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8216-8217]
[FR Doc No: 2013-02424]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68767; File No. SR-C2-2012-039]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Order Granting Approval to a Proposed Rule Change Relating to Bylaw and
Other Changes Concerning the Board of Directors of the Exchange

January 30, 2013.

I. Introduction

    On November 30, 2012, the C2 Options Exchange, Incorporated
(``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its Bylaws concerning
the nomination of Representative Directors, petition candidates, and
the size of the Exchange's Board of Directors (``Board''), and to make
conforming changes to the C2 Certificate of Incorporation. On December
19, 2012, the proposed rule change was published for comment in the
Federal Register.\3\ The Commission received no comments on the
proposed rule change. This order grants approval to the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 68429 (December 13,
2012), 77 FR 75237 (``Notice'').
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II. Description of the Proposed Rule Change

Compositional Requirements Determined by the Board
    In December of 2011, C2 amended its Bylaws and Certificate of
Incorporation to, among other things: (i) Eliminate the requirement
that its Board of Directors be composed of at least 30% Industry
Directors, and (ii) eliminate the requirement in Section 3.2 of the
Bylaws that the Representative Directors must be Industry Directors.\4\
In connection with these changes, C2 also amended Section 3.1 of the
Bylaws to provide that: ``[T]he Board shall determine from time to time
pursuant to resolution adopted by the Board the total number of
directors, the number of Non-Industry Directors and Industry Directors
(if any), and the number of Representative Directors that are Non-
Industry Directors and Industry Directors (if any).'' \5\
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    \4\ See Securities Exchange Act Release Nos. 65681 (November 3,
2011), 76 FR 69783 (November 9, 2011) (SR-C2-2011-031) (noticing for
comment); and 65979 (December 15, 2011), 76 FR 79239 (December 21,
2011) (approving SR-C2-2011-031).
    \5\ See C2 Bylaw 3.1. See also Securities Exchange Act Release
Nos. 65681 (November 3, 2011), 76 FR 69783 (November 9, 2011) (SR-
C2-2011-031) (noticing for comment).
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    C2 proposed to amend the Bylaws to expressly provide that any
person nominated by the Representative Director Nominating Body \6\ and
any petition candidate nominated pursuant to the Section 3.2 of the
Bylaws must satisfy the compositional requirements

determined by the Board pursuant to a resolution adopted by the Board
in accordance with Section 3.1 designating the number of Representative
Directors that are Non-Industry Directors and Industry Directors (if
any). C2 also proposed to amend Section 3.5 of the Bylaws relating to
the filling of vacancies on the Board to provide that the
Representative Director Nominating Body may only recommend individuals
to fill a vacancy in a Representative Director position who satisfy
those same compositional requirements.
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    \6\ The Exchange noted that at all times at least 20% of the
directors serving on the Board would be Representative Directors
nominated by the Representative Director Nominating Body as provided
in Section 3.2 of the Bylaws (or otherwise selected through the
petition process). See Notice, supra note 3, at 75237.
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Board Size Range
    Currently, the Bylaws provide that the Board shall consist of not
less than 11 and not more than 23 directors. C2 proposed to change the
Board size range such that the Board would consist of not less than 12
and not more than 16 directors.
Conforming Amendments to Certificate of Incorporation
    Finally, C2 proposed to make conforming changes to its Certificate
of Incorporation and to include in its Certificate of Incorporation
that the Board and/or Nominating and Governance Committee, as
applicable, shall make determinations as to whether a director
candidate satisfies applicable qualifications for election as a
director pursuant to and in accordance with Section 3.1 of the
Exchange's Bylaws, which is nearly identical to the current provisions
in the Exchange's existing Bylaws.

III. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\7\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(1) of the Act,\8\ which requires a
national securities exchange to be so organized and have the capacity
to carry out the purposes of the Act and to enforce compliance by its
members and persons associated with its members with the provisions of
the Act; Section 6(b)(3) of the Act,\9\ which requires that the rules
of a national securities exchange assure the fair representation of its
members in the selection of its directors and administration of its
affairs, and provide that one or more directors shall be representative
of issuers and investors and not be associated with a member of the
exchange, broker, or dealer (the ``fair representation requirement'');
and Section 6(b)(5) of the Act,\10\ in that it is designed, among other
things, to prevent fraudulent and manipulative acts and practices; to
promote just and equitable principles of trade; to remove impediments
to and perfect the mechanism of a free and open market and a national
market system; and, in general, to protect investors and the public
interest.
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    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(1).
    \9\ 15 U.S.C. 78f(b)(3).
    \10\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the Exchange's proposal to expressly
provide that any person nominated by the Representative Director
Nominating Body \11\ and any petition candidate nominated pursuant to
the Section 3.2 of the Bylaws must satisfy the compositional
requirements determined by the Board pursuant to a resolution adopted
by the Board in accordance with Section 3.1 of the Bylaws, as well as
the proposal to amend Section 3.5 of the Bylaws to provide that the
Representative Director Nominating Body may only recommend individuals
to fill a vacancy in a Representative Director position who satisfy
those same compositional requirements, are consistent with Section 6(b)
of the Act,\12\ including Section 6(b)(3) of the Act.\13\ The
Exchange's proposal would not impact its current process to ensure fair
representation of its Trading Permit Holders in the selection of its
directors and administration of its affairs as required by Section
6(b)(3) of the Act.\14\ Specifically, the proposed changes are
consistent with the changes to the Bylaws that C2 made in December of
2011 and simply reflect the application of those changes. As the
Commission noted when it approved that prior proposal, the Commission
had previously approved proposals in which an exchange's board of
directors was composed of all or nearly all non-industry directors
where the process was nevertheless designed to comply with the ``fair
representation'' requirement in the selection and election of
directors.\15\
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    \11\ See supra note 6.
    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(3). Section 6(b)(3) of the Act requires
that the rules of a national securities exchange assure the fair
representation of its members in the selection of its directors and
administration of its affairs, and provide that one or more
directors shall be representative of issuers and investors and not
be associated with a member of the exchange, broker, or dealer.
    \14\ See id.
    \15\ See Securities Exchange Act Release No. 65979 (December 15,
2011), 76 FR 79239 at 79241 (December 21, 2011) (approving SR-C2-
2011-031) (citing to Securities Exchange Act Release No. 48946
(December 17, 2003), 68 FR 74678 (December 24, 2003) (approving SR-
NYSE-2003-34)).
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    In addition, the Commission believes that the Exchange's proposal
to change the Board size range to consist of not less than 12 and not
more than 16 directors is consistent with Section 6(b) of the Act,\16\
including Section 6(b)(3) of the Act.\17\ The Exchange's proposal would
not impact in any manner its current process to ensure fair
representation of its Trading Permit Holders in the selection of its
directors and administration of its affairs as required by Section
6(b)(3) of the Act.\18\ Further, the proposed change is consistent with
the current size of C2's Board and simply narrows the possible size
range from 11 to 23 to 12 to 16.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(3).
    \18\ See id.
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IV. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the Act and the rules and regulations
thereunder applicable to a national securities exchange.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-C2-2012-039) be and hereby
is approved.
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    \19\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02424 Filed 2-4-13; 8:45 am]
BILLING CODE 8011-01-P