[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Notices]
[Pages 4688-4690]
[FR Doc No: 2011-1261]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0008; FRL-8856-1]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this Notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before February 25, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number specified within the table below, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number specified
for the pesticide of interest as shown in the registration application
summaries. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity

or contact information unless you provide it in the body of your
comment. If you send an e-mail comment directly to EPA without going
through regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or e-mail. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What should I consider as I prepare my comments for EPA?

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

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing currently registered active ingredients pursuant to the
provisions of section 3(c) of FIFRA, and is publishing this Notice of
such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
    1. Registration Numbers: 100-617, 100-618. Docket Number: EPA-HQ-
OPP-2009-1009. Company name and address: Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419. Active ingredient:
Propiconazole. Proposed Use(s): Mint, onion subgroups 3-07 A and B, and
berry subgroups 13-07 A, B, and G. Contact: Lisa Jones,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    2. Registration Numbers: 100-1067, 100-1217. Docket Number: EPA-HQ-
OPP-2010-0637. Company name and address: Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Paraquat
dichloride. Proposed Use(s): Atemoya, biriba, black sapote, canistel,
cherimoya, custard apple, feijoa, Ilama, jaboticaba, longan, lychee,
mamey sapote, mango, pawpaw, pomegranate, pulasan, rambutan, sapodilla,
soursop, Spanish lime, star apple, starfruit, sugar apple, wax jambu,
and white sapote. Contact: Hope Johnson,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    3. Registration Numbers: 352-728, 352-729, 352-730. Docket Number:
EPA-HQ-OPP-2010-0888. Company name and address: DuPont Crop Protection,
Stine-Haskell Research Center, P.O. Box 30, Newark, DE 19714. Active
ingredient: Chlorantraniliprole. Proposed Use(s): Bushberry subgroup,
large shrub/tree berry subgroup, low growing berry subgroup, Ti palm
roots, Ti palm leaves, root and tuber vegetables, leaves of foot and
tuber vegetables, sugar beet molasses, bulb onion subgroup, peanut
nutmeat, peanut hay and dried tea leaves. Contact: Kable Bo Davis,
(703) 306-0415<EMAIL_ADDRESS>    4. Registration Numbers: 59639-139, 59639-140. Docket Number: EPA-
HQ-OPP-2009-0481. Company name and address: Valent U.S.A. Corporation,
1600 Riviera Ave, Suite 200, Walnut

Creek, CA 94596. Active ingredient: Fluopicolide Technical. Proposed
Use(s): Brassica leafy greens subgroup 5B, potatoes, sugar beets,
carrots, and rotational wheat. Contact: Janet Whitehurst, (703) 305-
6129<EMAIL_ADDRESS>    5. Registration Number: 59639-142. Docket Number: EPA-HQ-OPP-2009-
0481. Company name and address: Valent U.S.A. Corporation, 1600 Riviera
Ave, Suite 200, Walnut Creek, CA 94596. Active ingredient: Fluopicolide
and Propamocarb Hydrochloride. Proposed Use(s): Potatoes, sugar beets,
carrots, and rotational wheat. Contact: Janet Whitehurst, (703) 305-
6129<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: January 10, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-1261 Filed 1-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31626-31627]
[FR Doc No: 2022-11155]

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DEPARTMENT OF TRANSPORTATION

[OMB Control No. 2105-0573; Docket No. DOT-OST-2022-0061]

Notice and Request for Comments on Revision of a Previously
Approved Information Collection Request

AGENCY: Department of Transportation.

ACTION: Notice; request for comment.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
Department of Transportation's (DOT) Office of the Secretary (OST)
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. Federal agencies have
been directed to provide service to the public that matches or exceeds
the best service available in the private sector. In order to work
continuously to ensure that our programs are effective and meet our
customers' needs, the Department of Transportation (DOT) seeks a
renewal without revision to a fast track generic clearance information
collection request already approved by OMB. OST requests renewal
without revision of ICR with OMB Control Number: 2105-0573 as described
below.

DATES: Submit comments on or before: July 25, 2022.

ADDRESSES: Submit comments identified by Information Collection 2105-
0573, Fast Track Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery, by any of the following methods:
     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.
     Mail: U.S. Department of Transportation, Office of the
Chief Information Officer, 1200 New Jersey Avenue SE, Washington, DC
20590. ATTN: Chief Data Officer/IC 2105-0573, Fast Track Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery.
    Instructions: Please submit comments only and cite Information
Collection 2105-0573, Fast Track Generic Clearance for the Collection
of Qualitative Feedback on Agency Service Delivery in all
correspondence related to this collection. To confirm receipt of your
comment(s), please check regulations.gov, approximately two-to-three
business days after submission to verify posting (except allow 30 days
for posting of comments submitted by mail).

FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Daniel Morgan, Assistant Chief Information
Officer for Data Services/Chief Data Officer, or via email to
[email protected] or or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Fast Track Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery.
    Abstract: The information collection activity will garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Department's commitment to improving
service delivery. By qualitative feedback we mean information that
provides useful insights on perceptions and opinions, but are not
statistical surveys that yield quantitative results that can be
generalized to the population of study. This feedback will provide
insight into customer or stakeholder perceptions, opinions, experiences
and expectations, provide an early warning of issues with service, or
focus attention on areas where communication, training or changes in
operations might improve delivery of products or services. These
collections will allow for ongoing, collaborative and actionable
communications between the Department of Transportation and its
customers and stakeholders. It will also allow feedback to contribute
directly to the improvement of program management. Feedback or
information collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population.
    The U.S. Department of Transportation will only submit collections
if they meet the following criteria.
     The collections are voluntary.

     The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government.
     The collections are noncontroversial and do not raise
issues of concern to other Federal agencies.
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future.
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained.
     Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the Department (if
released, the Department must indicate the qualitative nature of the
information).
    This type of generic clearance for qualitative information will not
be used for quantitative information collections that are designed to
yield reliably actionable results, such as monitoring trends over time
or documenting program performance. Such data uses require more
rigorous designs that address: The target population to which
generalizations will be made, the sampling frame, the sample design
(including stratification and clustering), the precision requirements
or power calculations that justify the proposed sample size, the
expected response rate, methods for assessing potential nonresponse
bias, the protocols for data collection, and any testing procedures
that were or will be undertaken prior to fielding the study. Depending
on the degree of influence the results are likely to have, such
collections may still be eligible for submission for other generic
mechanisms that are designed to yield quantitative results.
    Type of Review: Renewal without revision of a previously approved
Information Collection Request.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Estimated Number of Respondents: 240,000.
    Estimated Annual Responses: 80,000.
    Estimated Annual Burden Hours: 20,000 hours.
    Frequency: One-time requirement.
    Annual burden hours = (80,000 responses) x (15 minutes) = 1,200,000
min = 20,000 hours.
    Total burden hours for 3 years = 20,000 x 3 = 60,000 hours.
    Total respondents = 80,000 (each year) x 3 = 240,000.
    Request for Comments: Comments submitted in response to this notice
will be summarized and/or included in the request for OMB approval.
Comments are invited on: (a) Whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; (d) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology; and (e) estimates of capital or start-up costs and costs of
operation, maintenance, and purchase of services to provide
information.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; to develop, acquire, install and utilize
technology and systems for the purpose of collecting, validating and
verifying information, processing and maintaining information, and
disclosing and providing information; to train personnel and to be able
to respond to a collection of information, to search data sources, to
complete and review the collection of information; and to transmit or
otherwise disclose the information.
    All written comments will be available for public inspection
Regulations.gov.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid Office of Management and Budget control number.

    Dated: May 19, 2022.
Daniel Morgan,
Assistant Chief Information Officer for Data Services/Chief Data
Officer.
[FR Doc. 2022-11155 Filed 5-23-22; 8:45 am]
BILLING CODE 4910-9X-P


                                  MEMORANDUM

Tetra Tech, Inc.
10306 Eaton Place, Suite 340
Fairfax, VA 22030
phone<PHONE_NUMBER>
fax<PHONE_NUMBER>

TO:			Record
FROM:		Christine Wong, Tetra Tech, Inc.
DATE: 		April 15, 2009

SUBJECT:	Notes from teleconferences with Canada Department of Fisheries and Oceans staff

Background

To complement existing information on cooling water intake structures and intake technologies, EPA directed Tetra Tech (Tt) to research Canadian cooling water intake structures and intake technologies that might be of potential interest for site visitations by EPA and contractor personnel.

Methodology

Based on previous correspondence with personnel from Canada's Department of Fisheries and Oceans (DFO), the government agency responsible for overseeing programs and services that support the use and development of Canada's waterways and aquatic resources, Tt did not attempt to contact national-level DFO staff about individual cooling water intake structures and intake technologies, because such information is typically not aggregated at the national level.  Instead, based on the recommendation of previous contacts, Tt staff directly contacted personnel in the provincial governments of coastal provinces and those adjoining the Great Lakes, since the permitting process takes place at the provincial level.  Tt made telephone inquiries to the general information lines (provided at http://www.dfo-mpo.gc.ca/contact-eng.htm) at the Pacific, Central and Arctic, Gulf, Maritimes, and Newfoundland and Labrador regional DFO offices.  In each case, Tt inquiries were referred to personnel from the Fish Habitat Management Program.

Tt made contact with Fish Habitat Management Program personnel from the Vancouver, British Columbia; St. John's, Newfoundland; and Burlington, Ontario regional offices.  The discussion below summarizes the information gathered from these staff.

                         ****************************

Terry Fleet<PHONE_NUMBER>), Habitat Management Engineer in Newfoundland

Mr. Fleet knew of two examples of fish protection technologies on water intake structures, but did not know of any large-scale or widespread implementation of such technologies.  He knew of one example indirectly  -  a hydroelectric project in Great Falls, Newfoundland, for a pulp and paper mill has been using a louver system to guide fish away from the intake structure.  Mr. Fleet indicated that the louver is known to be approximately 75-80% effective at fish deterrence (specifically salmon deterrence), and suggested more information about the project is available on the Internet from Mr. Leon King<PHONE_NUMBER>).

Mr. Fleet spoke at length about another water intake project under his supervision. A municipal drinking water intake on the salmon-bearing Shoal Harbor River in Clarenville, Newfoundland, has a fine-mesh traveling to protect the fish from uptake.  He stated that the mesh is 1.3 mm and the intake velocity at this facility is typically less than 0.15 m/s (0.5 ft/s).  He noted that the environmental assessment for this project is likely available on the Internet.

Mr. Fleet stated that there are no requirements for fish protection at intakes in non-fish bearing waters, but noted that it is common to have some types of screens (generally, stationary screens) on water intakes (most are drinking water intakes) in fish-bearing water to prevent impingement, as well as debris buildup.  He indicated that there are no nuclear facilities in Newfoundland, but there are a number of geothermal and hydroelectric facilities.  Mr. Fleet noted that hydroelectric facilities do not necessarily have or are required to have screens on their intakes, and such requirements are made by regulatory personnel on a case-by-case basis.

                         ****************************

Al Johnson<PHONE_NUMBER>), Habitat Management and Enhancement Branch for the Lower Frazier area in Vancouver, BC

Mr. Johnson stated that fish protection technologies at water intake structures in the greater Vancouver area are only implemented at very small scale intakes; for example, on farms.  He stated that this is very likely true of all of British Columbia.

Mr. Johnson noted that all of the fish protection technologies at water intakes that he is aware of are being implemented in the United Stated in Washington state and California.

                         ****************************

Derrick Beach<PHONE_NUMBER>), Habitat Management Engineer for the greater Ontario area

Mr. Beach stated that Canada is still trying to catch up with the United States in terms of fish protection technologies on water intake structures.  He stated that he is working with some nuclear power plants on the Great Lakes to negotiate the potential installation of fish protection technologies on their intake structures.  He stated that these projects are still in the biological assessment stage; the facilities are studying the number of fish impacted by water intakes in the affected waterbodies.

Mr. Beach stated that most facilities do not have any kind of fish protection technologies on water intake structures, though many might have debris screens.  He noted one municipal drinking water facility that does have stationary fish protection screens, but did not know the mesh size of the screens.  He suggested that the mesh size is determined according to the size of the local fish intended to be protected.  Mr. Beach stated that habitat management personnel are most interested in preventing entrainment, noting the difficulty with maintenance (i.e., for deep intakes) in the Great Lakes.  He indicated that regulators in the area are interested in designing structures that can be retrofitted with screens and allow for continuous monitoring.

Mr. Beach indicated that all the intake screening that he knew of were all stationary screens; he did not know of any traveling screen technology being used on water intakes in the Great Lakes.  He stated that regulatory personnel were also looking into implementing requirements for reducing the intake velocity to protect fish.  He emphasized that all of the tools were being discussed, but none, to his knowledge, were being implemented yet.

Mr. Beach confirmed that the requirements and authority for protecting fish at water intakes comes from several different parts of the Fisheries Act, and that the language in those regulations is very general and does not contain specific implementation requirements.  He suggested that Habitat Management offices in British Columbia and the other maritime provinces might have more information on fish protection technologies.

During a follow-up conversation, Tt personnel spoke with Mr. Beach to confirm whether he knew of or was requiring any facilities, specifically nuclear generating facilities, to use closed-cycle recirculating systems (CCRSs) or changes in flow regimes for the purpose of fish protection.  He was chosen for these follow-up questions because his area has the highest concentration of power plants in Canada, which mainly derives its electricity from hydropower.

Mr. Beach stated that he does not know of any facilities that are using CCRSs or targeted flow regimes (i.e., seasonal changes, variable speed pumps, low intake velocity) for fish protection or other purposes.  He indicated that his department has been in negotiations (for many years) with facilities that may have intakes in biologically rich areas, but those talks have not yielded anything past discussions about what types of aquatic organism protection screening might be used at those intakes, per the Canadian guidelines for fish protection at intake structures, and has definitely not led to the installation flow-based technologies.  He noted that those negotiations have included some discussion of flow regime changes or CCRSs, but no facilities have yet used or been required to use those technologies or methods.  He mentioned that there has been a rumor circulating around SFO staff that the Fisheries Act, which contains the current guidelines for fish protection at intake structures, might be rewritten in the near future, but that is the extent of his knowledge about national rulemaking on this topic.


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8509-8511]
[FR Doc No: 2016-03462]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0096]

Determining the Extent of Safety Data Collection Needed in Late-
Stage Premarket and Postapproval Clinical Investigations; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Determining the
Extent of Safety Data Collection Needed in Late-Stage Premarket and
Postapproval Clinical Investigations.'' The guidance is intended to
help sponsors determine the amounts and types of safety data to collect
in late-stage premarket and postapproval clinical investigations based
on what is already known about a drug's safety profile. Sponsors
collect extensive safety data in clinical investigations of drug and
biological products conducted to support marketing approval (premarket)
and after approval (postapproval). FDA believes that selective safety
data collection may be possible for some late-stage premarket and
postapproval clinical investigations because certain aspects of a
drug's safety profile will be sufficiently well-established and
comprehensive data collection is not needed. This guidance finalizes
the draft guidance issued in February 2012.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2012-D-0096 for ``Determining the Extent of Safety Data Collection
Needed

in Late-Stage Premarket and Postapproval Clinical Investigations;
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993-0002, 301-
796-3691; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Determining the Extent of Safety Data Collection Needed in
Late-Stage Premarket and Postapproval Clinical Investigations.'' The
guidance is intended to help sponsors determine the amounts and types
of safety data to collect during late-stage premarket and postapproval
clinical investigations (e.g., phase 3 clinical trials, studies of new
uses, long-term outcomes) based on what is already known about a drug's
safety profile.
    If the drug's safety profile is well-established before completion
of clinical development or for marketed drugs used in postmarketing
clinical trials, it may no longer be necessary in some cases to collect
certain types of safety data. In some cases, collection of data that do
not contribute to better characterizing the safety profile of a drug
may have negative consequences. Additionally, excessive safety data
collection practices may discourage the conduct of certain types of
trials by increasing the resources needed to perform the trials and may
also be a disincentive to investigator and patient participation in
clinical trials. FDA believes that selective safety data collection
may: (1) Facilitate the conduct of larger trials without compromising
the integrity and the validity of trial results or losing important
information, (2) facilitate investigators' and patients' participation
in clinical trials, and (3) help contain costs by making more-efficient
use of clinical trial resources.
    The guidance outlines the circumstances where selective data
collection may be appropriate and the types of safety data that may be
eligible for selective collection. The guidance provides
recommendations on maintaining a balance between eliminating the
collection of data that will not be useful and collecting sufficient
data to allow adequate characterization of the safety profile of a drug
in scenarios where selective safety data collection is appropriate. The
guidance also strongly encourages sponsors to work closely with the
relevant FDA review division or divisions to establish and implement
selective safety data collection.
    In the Federal Register of February 10, 2012 (77 FR 7166), FDA
announced the availability of a draft guidance for industry of the same
title. The public comment period closed on April 10, 2012. FDA
carefully considered all comments received in developing the guidance.
In response to public comments requesting more detail and examples, the
guidance was revised and reorganized to clarify what types of safety
data and what circumstances may be appropriate for selective
collection, add detail regarding the draft guidance topics, and provide
additional information on safety data reporting issues. This guidance
finalizes the draft guidance issued in February 2012.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on determining the extent of safety data
collection needed in late-stage premarket and postapproval clinical
investigations. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 312.32 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
312.47 have been approved under OMB control numbers 0910-0014 and 0910-
0429; the collections of information in 21 CFR 314.80 have been
approved under OMB control number 0910-0230; and the collections of
information in 21 CFR 600.80 have been approved under OMB control
number 0910-0308.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03462 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58130-58133]
[FR Doc No: 2021-22806]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93312; File No. SR-PEARL-2021-50]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change by To Extend the
Pilot Related to the Market-Wide Circuit Breakers in Exchange Rule 2622

October 14, 2021.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on October 12, 2021, MIAX PEARL, LLC (``MIAX
Pearl'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to extend the pilot related to
the market-wide circuit breaker mechanism in Rule 2622.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
Pearl's principal office, and at the Commission's Public Reference
Room.

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

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

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

1. Purpose
    The Exchange proposes to extend the pilot related to the market-
wide circuit breaker mechanism in Rule 2622 to the close of business on
March 18, 2022.
Background
    The Market-Wide Circuit Breaker (``MWCB'') rules, including the
Exchange's Rule 2622, provide an important, automatic mechanism that is
invoked to promote stability and investor confidence during periods of
significant stress when cash equities securities experience extreme
market-wide declines. The MWCB rules are designed to slow the effects
of extreme price declines through coordinated trading halts across both
cash equity and equity options securities markets.
    The cash equities rules governing MWCBs were first adopted in 1988.
In 2012 all U.S. cash equity exchanges and FINRA amended their cash
equities uniform rules on a pilot basis \3\ and, in

2020, the Exchange adopted the cash equities uniform rule under
Exchange Rule 2622(a)-(d) to also operate on a pilot basis \4\ (the
``Pilot Rules''). The Pilot Rules currently provide for trading halts
in all cash equity securities during a severe market decline as
measured by a single-day decline in the S&P 500 Index (``SPX'').\5\
Under the Pilot Rules, a market-wide trading halt will be triggered if
SPX declines in price by specified percentages from the prior day's
closing price of that index. The triggers are set at three circuit
breaker thresholds: 7% (Level 1), 13% (Level 2), and 20% (Level 3). A
market decline that triggers a Level 1 or Level 2 halt after 9:30 a.m.
and before 3:25 p.m. would halt market-wide trading for 15 minutes,
while a similar market decline at or after 3:25 p.m. would not halt
market-wide trading. (Level 1 and Level 2 halts may occur only once a
day.) A market decline that triggers a Level 3 halt at any time during
the trading day would halt market-wide trading for the remainder of the
trading day.
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    \3\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-
025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-
30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-
2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SR-
NYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (``Pilot
Rules Approval Order''). See also Securities Exchange Act Release
No. 89563 (August 14, 2020), 85 FR 51510 (August 20, 2020) (SR-
PEARL-2020-03) (``Equities Approval Order'') (approving, among other
things, Exchange Rule 2622).
    \4\ See Equities Approval Order, id.
    \5\ The rules of the equity options exchanges similarly provide
for a halt in trading if the cash equity exchanges invoke a MWCB
Halt. See, e.g., Exchange Rule 504(a) and NYSE Arca Rule 6.65-
O(d)(4).
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    Exchange Rule 2622 was approved by the Commission to operate on a
pilot basis set to expire on at the close of business on October 18,
2020.\6\ The Exchange subsequently amended Rule 2622 to extend the
Pilot Rules' effectiveness for an additional year to the close of
business on October 18, 2021.\7\
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    \6\ See Equities Approval Order, supra note 3.
    \7\ See Securities Exchange Act Release No. 90124 (October 8,
2020), 85 FR 65105 (October 14, 2020) (SR-PEARL-2020-20).
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    The Exchange now proposes to amend Rule 2622 to extend the pilot to
the close of business on March 18, 2022. This filing does not propose
any substantive or additional changes to Rule 2622.
The MWCB Task Force and the March 2020 MWCB Events
    In late 2019, Commission staff requested the formation of a MWCB
Task Force (``Task Force'') to evaluate the operation and design of the
MWCB mechanism. The Task Force included representatives from the SROs,
the Commission, CME, the Commodity Futures Trading Commission
(``CFTC''), and the securities industry and conducted several
organizational meetings in December 2019 and January 2020.
    In Spring 2020, the MWCB mechanism proved itself to be an effective
tool for protecting markets through turbulent times. In March 2020, at
the outset of the worldwide COVID-19 pandemic, U.S. equities markets
experienced four MWCB Level 1 halts, on March 9, 12, 16, and 18, 2020.
In each instance, the markets halted as intended upon a 7% drop in the
S&P 500 Index, and resumed as intended 15 minutes later.
    In response to these events, in the Spring and Summer of 2020, the
Task Force held ten meetings that were attended by Commission staff,
with the goal of performing an expedited review of the March 2020 halts
and identifying any areas where the MWCB mechanism had not worked
properly. Given the risk of unintended consequences, the Task Force did
not recommend changes that were not rooted in a noted deficiency. The
Task Force recommended creating a process for a backup reference price
in the event that SPX were to become unavailable, and enhancing
functional MWCB testing. The Task Force also asked CME to consider
modifying its rules to enter into a limit-down state in the futures
pre-market after a 7% decline instead of 5%. CME made the requested
change, which became effective on October 12, 2020.\8\
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    \8\ See https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rule-filings/2020/9/20-392_1.pdf; https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rule-filings/2020/9/20-392_2.pdf.
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The MWCB Working Group's Study
    On September 17, 2020, the Director of the Commission's Division of
Trading and Markets asked the SROs to conduct a more complete study of
the design and operation of the Pilot Rules and the LULD Plan during
the period of volatility in the Spring of 2020.
    In response to the request, the SROs created a MWCB ``Working
Group'' composed of SRO representatives and industry advisers that
included members of the advisory committees to both the LULD Plan and
the NMS Plans governing the collection, consolidation, and
dissemination of last-sale transaction reports and quotations in NMS
Stocks. The Working Group met regularly from September 2020 through
March 2021 to consider the Commission's request, review data, and
compile its study. The Working Group's efforts in this respect
incorporated and built on the work of an MWCB Task Force.
    The Working Group submitted its study to the Commission on March
31, 2021 (the ``Study'').\9\ In addition to a timeline of the MWCB
events in March 2020, the Study includes a summary of the analysis and
recommendations of the MWCB Task Force; an evaluation of the operation
of the Pilot Rules during the March 2020 events; an evaluation of the
design of the current MWCB system; and the Working Group's conclusions
and recommendations.
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    \9\ See Report of the Market-Wide Circuit Breaker (``MWCB'')
Working Group Regarding the March 2020 MWCB Events, submitted March
31, 2021 (the ``Study''), available at https://www.nyse.com/publicdocs/nyse/markets/nyse/Report_of_the_Market-Wide_Circuit_Breaker_Working_Group.pdf.
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    In the Study, the Working Group concluded: (1) The MWCB mechanism
set out in the Pilot Rules worked as intended during the March 2020
events; (2) the MWCB halts triggered in March 2020 appear to have had
the intended effect of calming volatility in the market, without
causing harm; (3) the design of the MWCB mechanism with respect to
reference value (SPX), trigger levels (7%/13%/20%), and halt times (15
minutes) is appropriate; (4) the change implemented in Amendment 10 to
the Plan to Address Extraordinary Market Volatility (the ``Limit Up/
Limit Down Plan'' or ``LULD Plan'') did not likely have any negative
impact on MWCB functionality; and (5) no changes should be made to the
mechanism to prevent the market from halting shortly after the opening
of regular trading hours at 9:30 a.m.
    In light of the foregoing conclusions, the Working Group also made
several recommendations, including that the Pilot Rules should be
permanent without any changes.\10\
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    \10\ See id. at 46.
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Proposal To Extend the Operation of the Pilot Rules Pending the
Commission's Consideration of the Exchange's Filing To Make the Pilot
Rules Permanent
    On July 16, 2021, the New York Stock Exchange LLC (``NYSE'')
proposed a rule change to make the Pilot Rules permanent, consistent
with the Working Group's recommendations.\11\ On August 27, 2021, the
Commission extended its time to consider the proposed rule change to
October 20, 2021.\12\ The Exchange now proposes to extend the

expiration date of the Pilot Rules to the end of business on March 18,
2022.
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    \11\ See Securities Exchange Act Release No. 92428 (July 16,
2021), 86 FR 38776 (July 22, 2021) (SR-NYSE-2021-40).
    \12\ See Securities Exchange Act Release No. 92785A (August 27,
2021), 86 FR 50202 (September 7, 2021) (SR-NYSE-2021-40).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\13\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\14\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest. The MWCB mechanism under Rule 2622 is an important, automatic
mechanism that is invoked to promote stability and investor confidence
during a period of significant stress when securities markets
experience extreme broad-based declines. Extending the MWCB pilot for
an additional five months would ensure the continued, uninterrupted
operation of a consistent mechanism to halt trading across the U.S.
markets while the Commission reviews the Exchange's proposed rule
change to make the Pilot Rules permanent.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that the proposed rule change promotes
just and equitable principles of trade in that it promotes transparency
and uniformity across markets concerning when and how to halt trading
in all stocks as a result of extraordinary market volatility. Based on
the foregoing, the Exchange believes the benefits to market
participants from Pilot Rules should continue on a pilot basis because
they will promote fair and orderly markets and protect investors and
the public interest.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act because the proposal would
ensure the continued, uninterrupted operation of a consistent mechanism
to halt trading across the U.S. markets while the Commission reviews
the NYSE's proposed rule change to make the Pilot Rules permanent.
    Further, the Exchange understands that FINRA and other national
securities exchanges will file proposals to extend their rules
regarding the MWCB pilot. Thus, the proposed rule change will help to
ensure consistency across market centers without implicating any
competitive issues.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \15\ and Rule 19b-4(f)(6) \16\
thereunder.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \17\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\18\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange asked
that the Commission waive the 30 day operative delay so that the
proposal may become operative immediately upon filing. Extending the
Pilot Rules' effectiveness to the close of business on March 18, 2022
will extend the protections provided by the Pilot Rules, which would
otherwise expire in less than 30 days. Waiver of the operative delay
would therefore permit uninterrupted continuation of the MWCB pilot
while the Commission reviews the NYSE's proposed rule change to make
the Pilot Rules permanent. Therefore, the Commission hereby waives the
30-day operative delay and designates the proposed rule change as
operative upon filing.\19\
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    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 17 CFR 240.19b-4(f)(6)(iii).
    \19\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR- PEARL-2021-50 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-PEARL-2021-50. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).

    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-PEARL-2021-50 and

should be submitted on or before November 10, 2021. 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).

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-22806 Filed 10-19-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Page 32136]
[FR Doc No: 2015-13696]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0362]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Current Good Manufacturing Practices
for Finished Pharmaceuticals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Current Good Manufacturing
Practices for Finished Pharmaceuticals'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On March 06, 2015, the Agency submitted a
proposed collection of information entitled ``Current Good
Manufacturing Practices for Finished Pharmaceuticals'' to OMB for
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0139. The approval expires on May 31, 2018. A copy
of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13696 Filed 6-4-15; 8:45 am]
BILLING CODE 4164-01-P