[Federal Register Volume 76, Number 232 (Friday, December 2, 2011)]
[Notices]
[Page 75542]
[FR Doc No: 2011-30971]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-6729-000]

Hermance, Frank S.; Notice of Filing

    Take notice that on November 23, 2011, Frank S. Hermance submitted
for filing, an application for authority to hold interlocking
positions, pursuant to section 305(b) of the Federal Power Act, 16
U.S.C. 825d (b) and Part 45 of Title 18 of the Code of Federal
Regulations, 18 CFR part 45.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 14, 2011.

    Dated: November 25, 2011.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2011-30971 Filed 12-1-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58548-58549]
[FR Doc No: 2011-24328]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Federal Register citation of previous announcement: [76 FR 57772].

STATUS:  Open Meeting.

PLACE:  100 F Street, NW., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING:  September 19, 2011 at
10 a.m.

CHANGE IN THE MEETING:  Deletion of an Item.
    The following item will not be considered during the Commission's
Open Meeting on September 19, 2011 at 10 a.m.
    The Commission will consider whether to propose new rules under
Section 764(a) of the Dodd-Frank Wall Street Reform and Consumer
Protection Act to provide for the registration of security-based swap
dealers and major security-based swap participants.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if

any, matters have been added, deleted or postponed, please contact the
Office of the Secretary at<PHONE_NUMBER>.

     September 16, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-24328 Filed 9-19-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51995-51996]
[FR Doc No: 2022-18265]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0430]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quick Turnaround Testing of Communication Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 23, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0876. Also include the FDA docket
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Clearance for Quick Turnaround Testing of Communication
Effectiveness

OMB Control Number 0910-0876--Extension

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role consumers and stakeholders play in ensuring the safety of the food
supply, which helps ensure that suppliers produce food that meets U.S.
safety standards.
    Occasionally, FDA will need to communicate with consumers and other
stakeholders about immediate health issues that could affect public
health and safety. This collection of information allows the use of
fast-track methods of communication such as quick turnaround surveys,
focus groups, and indepth interviews collected from consumers and other
stakeholders to communicate FDA issues of immediate and important
public health significance. We plan on using these methods of
communication to collect vital public health and safety information.
    For example, these methods of communication might be used when
there is a foodborne illness outbreak, food recall, or other situation
requiring expedited FDA food, dietary supplement, cosmetics, or animal
food or feed communications. So that FDA may better protect the public
health, the Agency needs quick turnaround information provided by this
collection of information to help ensure its messaging has reached the
target audience, has been effective, and, if needed, to update its
communications during these events.
    Respondents to this collection of information include a wide range
of consumers and other FDA stakeholders such as producers and
manufacturers of FDA-regulated food and cosmetic products, dietary
supplements, and animal food and feed. Participation will be voluntary.
    In the Federal Register of April 18, 2022 (87 FR 22906), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, they
were not responsive to the four collection of information topics
solicited.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                 Survey type                     Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indepth Interviews, Cognitive Interviews                  45               1              45  0.083 (5 minutes).........................               4
 Screener.
Indepth Interviews, Cognitive Interviews....               9               1               9  1.........................................               9
Indepth Interviews Screener.................             900               1             900  0.083 (5 minutes).........................              75
Indepth Interviews..........................             180               1             180  1.........................................             180
Survey Cognitive Interviews Screener........              45               1              45  0.083 (5 minutes).........................               4
Survey Cognitive Interviews.................               9               1               9  1.........................................               9
Pretest Survey Screener.....................             750               1             750  0.083 (5 minutes).........................              62
Pretest Survey..............................             150               1             150  0.25 (15 minutes).........................              38
Self-Administered Surveys--Study Screener...          75,000               1          75,000  0.083 (5 minutes).........................           6,225
Self-Administered Surveys...................          15,000               1          15,000  0.25 (15 minutes).........................           3,750
Focus Group/Small Group, Cognitive Groups                180               1             180  0.083 (5 minutes).........................              15
 Screener.
Focus Group/Small Group, Cognitive Groups...              60               1              60  1.5 (90 minutes)..........................              90
Focus Group/Small Group Participant                      720               1             720  0.083 (5 minutes).........................              60
 Screening.
Focus Group/Small Group Discussion..........             240               1             240  1.5 (90 minutes)..........................             360
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          10,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18265 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Pages 70951-70953]
[FR Doc No: 2013-28438]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1423]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Importer's Entry Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit either electronic or written comments on the collection
of information by January 27, 2014.

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

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Information Request Regarding Importer's Entry Notice--(OMB Control
Number 0910-0046)--Extension

    Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (U.S.C. 381) charges the Secretary of Health and Human Services
(HHS), through FDA, with the responsibility of assuring foreign origin
FDA regulated foods, drugs, cosmetics, medical devices, radiological
health, and tobacco products offered for import into the United States
meet the same requirements of the FD&C Act as do domestic products, and
for preventing products from entering the country if they are not in
compliance. The discharge of this responsibility involves close
coordination and cooperation

between FDA headquarters and field inspectional personnel and the U.S.
Customs Service (USCS), as the USCS is responsible for enforcing the
revenue laws covering the very same products.
    This collection of information gathers data for FDA-regulated
products being imported into the United States and is being used by FDA
to review and prevent imported products from entering the United States
if the products do not meet the same requirements of the FD&C Act as
domestic products.
    Until October 1995, importers were required to file manual entries
on OMB-approved forms which were accompanied by related documents. FDA
did away with use of the paper forms effective October 1, 1995, to
eliminate duplicity of information and to reduce the paperwork burden
both on the import community and FDA. FDA then implemented an automated
nationwide entry processing system which enabled FDA to more
efficiently obtain and process the information it requires to fulfill
its regulatory responsibility.
    Most of the information FDA requires to carry out its regulatory
responsibilities under section 801 is already provided electronically
by filers to USCS. Because USCS relays this data to FDA using an
electronic interface, the majority of data submitted by the entry filer
need be completed only once.
    At each U.S. port of entry (seaport, landport, and airport) where
foreign-origin, FDA-regulated products are offered for import, FDA is
notified through USCS's Automated Commercial System (ACS) by the
importer (or his/her agent) of the arrival of each entry. Following
such notification, FDA reviews relevant data to ensure the imported
product meets the standards as required for domestic products, decides
on the admissibility of the imported product, and informs the importer
and USCS of its decision. A single entry frequently contains multiple
lines of different products. FDA may authorize products listed on
specific lines to enter the United States unimpeded, while other
products listed in the same entry may be held pending further FDA
review/action.
    All entry data pass through a screening criteria program resident
on a USCS computer. This screening program was developed and is
maintained by FDA. This electronic screening criteria module makes the
initial screening decision on every entry of foreign-origin, FDA-
regulated product. Almost instantaneously after the entry is filed, the
filer receives FDA's admissibility decision for each entry, i.e., ``MAY
PROCEED'' or ``FDA REVIEW.''
    In addition to the information collected by USCS, FDA requires four
additional pieces of information that were not available from USCS's
system in order to make an admissibility decision for each entry. These
data elements include the FDA Product Code, FDA country of production,
manufacturer/shipper, and ultimate consignee. OMB has previously
approved the automated collection of these four data elements for
tobacco products that filers could provide to FDA along with other
entry-related information. Providing this information to FDA results in
importers receiving an FDA admissibility decision more expeditiously,
e.g., the quantity, value, and Affirmation(s) of Compliance with
Qualifier(s).
    Since the inception of the interface with ACS, FDA's electronic
screening criteria program has been applied nationwide. This eliminates
issues such as ``port shopping'' (attempts to intentionally slip
products through one FDA port when refused by another, or filing
entries at a port known to receive a high volume of entries). Every
electronically submitted entry line of foreign-origin, FDA-regulated
product undergoes automated screening and the screening criteria can be
set to be as specific or as broad as applicable; changes are
immediately effective. This capability is of tremendous value in
protecting the public if there is a need to immediately halt specific
product from entering the United States.
    If the data in this collection of information is not collected, FDA
could not adequately meet its statutory responsibilities to regulate
imported products, nor control potentially dangerous products from
entering the U.S. marketplace.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    FDA Imported Products         Number of      responses per    Total annual   Average  burden    Total hours
                                 respondents      respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
Non-Tobacco..................           3,406             1,089       3,709,134  .14............         519,279
                                                                                (8 minutes)....
Tobacco......................             330                68          22,440  .14............            3142
                                                                                (8 minutes)....
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............         522,421
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The hourly burden for this information collection is based on FDA's
averaging of data obtained during a survey of nine representative
filers nationwide and FDA's experience. For purposes of comparison of
hourly burden, the filers also were requested to provide the same
information with regard to filing entries manually. FDA felt that the
average time for completing either electronic or manual entries was
very similar.
    Based on data collected by FDA's survey of nine filers and its
experience, the total annual burden to the import community to submit
information electronically for 3,731,574 average annual responses was
522,421 hours. The previously OMB-approved hours per response (0.14
hours) are expected to remain the same.
    This burden includes the time FDA estimates it will take
respondents to compile and provide documents to FDA for those entries
where FDA cannot make an admissibility decision based on the electronic
data alone. Based on the survey of nine filers and FDA's past
experience, FDA estimates that there will be no additional costs to
provide import data electronically to FDA, as filers already have
equipment and software in place to enable them to provide data to USCS
via the automated system. Therefore, no additional software or hardware
need be developed or purchased to enable filers to file the FDA data
elements at the same time they file entries electronically with USCS.

    Dated: November 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28438 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P