[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21680-21682]
[FR Doc No: 2023-07515]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1005]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 generic collection of
focus group information as used by FDA for all FDA-regulated products.

DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be

considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of June
12, 2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received 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-2023-N-1005 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Focus Groups as Used by the Food
and Drug Administration.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

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. 3501-3521), 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.

Focus Groups as Used by the Food and Drug Administration

OMB Control Number 0910-0497--Extension

    FDA conducts focus group interviews on a variety of topics
involving FDA-regulated products, including drugs, biologics, devices,
food, tobacco products, and veterinary medicine.
    Focus groups provide an important role in gathering information
because they allow for a more in-depth understanding of consumers'
attitudes, beliefs, motivations, and feelings than do quantitative
studies. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and as a qualitative research tool
have three major purposes:
     To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in
response to topics and concepts, and
     To further explore findings obtained from quantitative
studies.
    FDA will use focus group findings to test and refine ideas but will
generally conduct further research before making important decisions,
such as adopting new policies and allocating or redirecting significant
resources to support these policies.

    Respondents to this collection of information will include members
of the general public, healthcare professionals, the industry, and
other stakeholders who are related to a product under FDA's
jurisdiction. Inclusion and exclusion criteria will vary depending on
the research topic.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus group interviews.............................................          12,000                1           12,000             1.75           21,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden for the information collection reflects an
overall increase of 5,600 hours and a corresponding increase of 3,200
responses. We increased the number of consolidating the burden from ICR
0910-0677, ``Focus Groups About Drug Products as Used by the Food and
Drug Administration.''

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07515 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Page 18852]
[FR Doc No: 2016-07417]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9026-3]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements
Filed 03/21/2016 Through 03/25/2016
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20160066, Final, BOP, KY, U.S. Penitentiary and Federal Prison
Camp Letcher County, Review Period Ends: 05/02/2016, Contact: Issac
Gaston<PHONE_NUMBER>.
EIS No. 20160067, Final, USACE, NGA, MO, Next NGA West Campus in the
Greater St. Louis Metropolitan Area, Review Period Ends: 05/02/2016,
Contact: David Berczek<PHONE_NUMBER>.
EIS No. 20160068, Final, USFS, ID, Becker Integrated Resource Project
(Formerly the Becker Vegetation Management Project), Review Period
Ends: 05/16/2016, Contact: Michael Feiger<PHONE_NUMBER>.
EIS No. 20160069, Draft, FERC, TX, Golden Pass LNG Export Project,
Comment Period Ends: 05/16/2016, Contact: Eric Howard<PHONE_NUMBER>.

Amended Notices

EIS No. 20160034, Second Draft Supplemental, USFS, MT, Rock Creek Mine
Project, Comment Period Ends: 04/19/2016, Contact: Michael Huffine 406-
293-6211, Revision to FR Notice published 02/19/2016; Extending Comment
Period from 04/04/2016 to 04/19/2016.

    Dated: March 29, 2016.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2016-07417 Filed 3-31-16; 8:45 am]
 BILLING CODE 6560-50-P


Region 5 Monthly Tribal Air Call { Minutes  April 1, 2004}

Attendees US EPA: Faye Blondin, State and Tribal Planning Section Aunjanee' Gautreaux, State and Tribal Planning Section Robert ( Bob) Miller, Chief State and Tribal Planning Section Alexis Cain, Integrated Air Toxics Section Jackie Nwia, Integrated Air Toxics Section Chris Panos, Criteria Pollutant Section Meghan McGuinness, Clean Air Markets Division ( HQ) MaryJo Krolewski, Clean Air Markets Division ( HQ) Bill Maxwell, Office of Air Quality Planning & Standards ( RTP)

Tribal Representatives: Lynn Hall & Jamie Ekholm ( Bad River) Dwight Sargent ( Bay Mills, also with Michigan Inter Tribal Council) Sara Polski ( Bois Forte) Nick Axtel ( Fond du Lac) Victor Aubid ( Grand Portage) Mike Tenenbaum ( Gun Lake) Frank Beaver ( Little River Band) Gary Schuettpelz & Heather Pyatskowit ( Menominee) Lois Bressette ( Oneida)

Other Representatives: Chuck Layman, CENRAP/ CenSARA Continuation of Discussions on EPA's Proposed Utility Mercury Reduction Rule Alexis Cain gave a short recap of the previous elements discussed on the initial conference call held on March 19th. MaryJo Krolewski stated that EPA headquarter's had not yet received any comments on the proposed utility mercury reduction rule and encouraged tribal representatives to submit comments before the end of the comment period, at the end of April. There was a discussion of creating set asides of mercury allowances for utility boilers located on tribal lands, including potential new sources. Since this issue was not addressed in the proposed rule, EPA will not be able to address it unless we receive written comments on the issue. More information on the proposed rule is available at: http:// www. epa. gov/ air/ mercuryrule/

There was an inquiry of the status of the Interstate Air Quality ( IAQ) Rule, which will address emissions of sulfur dioxide and oxides of nitrogen. Meghan McGuinness stated that her office had not settled on a final conclusion of how to address comments received.

MaryJo Krolewski presented the group with a general understanding of the methodology for budgeting mercury emissions allowances to states. Allowances are allocated based on the heat input rates at utilities within the state ( using the average of the three highest years between 1998 and 2002). These heat input rates are then adjusted, based on boiler type. Then each state receives a mercury emissions budget proportionate to its share of the total adjusted heat input rate. For 2018, the state budgets will add to 15 tons.

Alexis clarified that the rule was proposed for coal fired electric utility mercury emissions, only.

Frank Beaver of the Little River Band expressed his concern that the proposed rule would impact their reservation because of the proposed coal fired plant on it.

Lynn Hall inquired about tribes ability to get involved if the Cap & Trade program was developed. Alexis stated that one option could be a program that would allow tribes to receive allowances for new sources on reservation lands, with the number of allowances depending on the size of the source as well as several other factors. Bob Miller, with confirmation from Alexis, clarified that allowances would be set aside for tribes who apply for it; it would not be otherwise distributed on an automatic basis. Alexis also said that the rest of the emissions budget would need to be reduced to accommodate new sources ( to keep the budget for 2018 at 15 tons, for instance).

Update on Midwest Regional Planning Organization ( RPO) Tribal emissions inventory and air quality data analysis projects Mike Koerber, Executive Director of the Lake Michigan Air Director Consortium, was on travel and unable to provide an update on the Tribal emissions inventory ( EI) development project. However, he asked me to mention that the only item to note is that Sarah Kelly ( ITEP) sent out a survey requesting when to have TEISS training. So, please respond to Sarah's survey.

Update on CENRAP Chuck Layman, CENRAP/ CenSARA Executive Director, discussed areas of interests for Region 5 tribes. CENRAP continues to work on completing the current emissions inventory activities, model performance evaluations, operation and maintenance of the monitoring network and data analysis. CENRAP is currently waiting for EPA to determine the amount of allocation for the FY' 04 RPO grants. Also, on a national level, the Grant Guidance Document currently out for comment. CENRAP commented because they were not reflected positively. They further requested that the comment period be extended for the IAQR and Mercury rules. A meeting of CENRAP's workgroup co chairs and other selected active participants in Oklahoma City and had a successful meeting to coordinate and refocus on the tasks at hand. Charlie Lippert . Chuck also reminded the group that the CENRAP workgroups will be meeting in Arkansas this month. Update on PM 2.5 Designations John Summerhays was presented with a scheduling conflict so Chris Panos spoke on his behalf. He informed us that they have received numerous recommendation letters from both states and tribal partners. He was asked whether or not the state of Wisconsin has provided a recommendation, to which he replied no. On the other hand, there was one received from the state of Michigan. For more detailed information, we were provided with the website address: www. epa. gov/ pmdesignations. The due date for these recommendation letters was February 15, however Lynn Hall of the Bad River Band was not able to meet this deadline because she was waiting on previously requested design values from EPA staff. Faye and Chris stated they would get her the information. Faye mentioned that EPA was cognizant of this fact and others issues which prevented several Region 5 tribes from meeting this deadline. EPA is still accepting letters from those tribes still wanting to submit a recommendation. The 120 day letters are scheduled to go out in July and will promulgate final PM 2.5 designations by December 15, 2004.

General Announcements/ Open Forum * Reminder, the 2004 NTEC Conference is scheduled for April 19 22 at the Catawba Indian Nation of South Carolina. And Dwight Sargent of the Michigan Inter Tribal Council informed us that the next NTAA Executive Committee meeting would be held in conjunction with the NTEC meeting. He further requested that anyone wishing to submit agenda items send them to him at dwights@ itcmi. org.

* Sara Polski of the Bois Forte Band stated that the Indoor Air Quality training that was recently held on the Fond du Lac Reservation was a success.

* Faye mentioned that EPA staff was in the process of scheduling technical systems audits for Tribal ambient monitoring networks.

* Discussions were initiated to inquire when and where we would be holding the 2004 Region 5 Tribal Air Meeting which was held this pass July at the EPA office building in Chicago. Sara Polski expressed that the July ( end of summer) time frame was workable for her. Everyone was asked to review there schedules for discussions on future calls.

Next Call is scheduled for April 29, 2004, ( 10: 00am  12: 00pm central).


[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49476]
[FR Doc No: 2012-20099]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17f-2(a), SEC File No. 270-34, OMB Control No. 3235-0034.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information for Rule 17f-2(a) (17 CFR 240.17-2(a)), under
the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
    Rule 17f-2(a) (Fingerprinting Requirements for Securities
Professionals) requires that securities professionals be fingerprinted.
This requirement serves to identify security-risk personnel, to allow
an employer to make fully informed employment decisions, and to deter
possible wrongdoers from seeking employment in the securities industry.
Partners, directors, officers, and employees of exchanges, brokers,
dealers, transfer agents, and clearing agencies are included.
    The Commission staff estimates that approximately 10,000
respondents will submit fingerprint cards each year. It also estimates
that each respondent will submit 55 fingerprint cards per year. The
staff estimates that the average number of hours necessary to comply
with Rule 17f-2(a) by completing a fingerprint card is one-half hour.
Thus, the total estimated annual burden is 275,000 hours for all
respondents (550,000 times one-half hour). The average estimated
internal labor cost of compliance per hour is approximately $50.
Therefore, the total estimated annual internal labor cost of compliance
for all respondents is $13,750,000 (275,000 times $50).
    Fingerprint cards submitted under Rule 17f-2(a) must be retained
for a period of not less than three years after termination of the
person's employment relationship with the organization. Submitting
fingerprint cards for all securities personnel is mandatory to obtain
the benefit of identifying security-risk personnel, allowing an
employer to make fully informed employment decisions and deterring
possible wrongdoers from seeking employment in the securities industry.
Fingerprint cards submitted according to Rule 17f-2(a) will not be kept
confidential.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid OMB control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid OMB control number.
    Background documentation for this information collection may be
viewed at the following Web site: www.reginfo.gov. Comments should be
directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, Virginia 22312 or send an email to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: August 10, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-20099 Filed 8-15-12; 8:45 am]
BILLING CODE 8011-01-P