[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Notices]
[Page 48699-48705]
[DOCID:fr11au10-75]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0004]
[FDA 225-10-0010]

Memorandum of Understanding Between United States Food and Drug
Administration and the Centers for Medicare and Medicaid Services

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the Centers for
Medicare and Medicaid Services (CMS), both part of the U.S. Department
of Health and Human Services. The purpose of the MOU is to promote
collaboration and enhance knowledge of efficiency by providing for the
sharing of information and expertise between the Federal partners. The
goals of the collaboration are to explore ways to further enhance
information sharing efforts through more efficient and robust inter-
agency activities; promote efficient utilization of tools and expertise
for product analysis, validation, and risk identification; and build
infrastructure and processes that meet the common needs for evaluating
the safety, efficacy, utilization, coverage, payment, and clinical
benefit of drugs, biologics, and medical devices.

DATES: The agreement became effective June 25, 2010.

FOR FURTHER INFORMATION CONTACT: David H. Dorsey, Office of Policy,
Planning and Budget, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4222, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c),

which states that all written agreements and MOUs between FDA and
others shall be published in the Federal Register, the agency is
publishing notice of this MOU.

    Dated: August 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4234-4235]
[FR Doc No: 2022-01637]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0085; FRL-9509-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for New Residential Wood Heaters
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), NSPS for New Residential Wood
Heaters (EPA ICR Number 1176.14, OMB Control Number 2060-0161), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through March 31,
2022. Public comments were previously requested, via the Federal
Register, on April 13, 2021 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before February 28,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2021-0085, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov, or in person at the EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: Manufacturers of wood heaters and testing laboratories
and third-party certifiers are required to comply with reporting and
record keeping requirements for the General Provisions (40 CFR part 60,
subpart A), as well as for the applicable specific standards in 40 CFR
part 60 Subpart AAA. This includes submitting initial notifications,
performance tests and periodic reports and results, and maintaining
records. These reports are used by EPA to determine compliance with
these standards.
    Form Numbers: None.
    Respondents/affected entities: Manufacturers of wood heating
appliances, testing laboratories, third-party certifiers.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart AAA).
    Estimated number of respondents: 62 (total).
    Frequency of response: Annually, biennially, every five years.
    Total estimated burden: 4,380 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,180,000 (per year), which includes
$657,000 in annualized capital startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is an increase in burden from the
most-recently approved ICR as currently identified in the OMB Inventory
of Approved Burdens. This is due to several considerations. Among other
considerations, the number of manufacturers and the number of certified
woodstove model lines have both increased since the previous ICR.

These two factors have contributed to an increase in respondents, labor
burden, and in the number of responses.
    The growth rate for manufacturers entering this industry has slowed
since the previous ICR, and no new respondents are expected during the
three-year period of this ICR. The number of existing testing
laboratories and third-party certifiers has remained constant since the
previous ICR. The capital/startup costs have decreased since the
previous ICR, which occurred during a period when manufacturers were
introducing approximately 30 new model lines each year to comply with
Step 2 requirements. In this ICR, we expect the introduction of new
model lines to be 15 per year. This results in a decrease in capital/
startup costs for performance testing and new model certification.
There is an increase in operation and maintenance (O&M) costs
reflecting the increase in model lines that are tested as part of the
manufacturers Quality Assurance Program. Also, in this ICR, we have
reorganized Table 1, Table 2, and the Total Annual Responses tables to
separate requirements for new model lines from existing model lines.
This ICR also reorganizes the Capital/Startup vs. Operation and
Maintenance (O&M) Costs table to distinguish between initial costs for
new models and operation and maintenance costs for existing models.
Additionally, this ICR adjusts the labor assumptions for the `burden'
associated with manufacturer review of QA annual audit reports provided
by third-party certifiers to reflect that audits are anticipated to be
performed for all of a single manufacturer's model lines in one visit
and the results of the audits would be presented in a single batch or
report for manufacturer review. Similarly, this ICR assumes that third-
party certifiers will prepare the QA annual audit report on a
manufacturer, rather than model line, basis. Finally, this ICR also
adjusts the labor assumptions associated with recordkeeping
requirements for manufacturers for test documentation and for retention
of sealed stoves to reflect that the number of model lines per
manufacturer and the frequency of the activity. These adjustments
minimally reduce burden for these activities, however, there remains an
overall increase in burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-01637 Filed 1-26-22; 8:45 am]
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[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43566-43567]
[FR Doc No: 2023-14460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2438]

Medical Imaging Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Medical Imaging Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on August 1, 2023, from 12 p.m. to 5
p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-2438. Please note that late, untimely
filed comments will not be considered. The docket will close on July
31, 2023. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of July 31,
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.
    Comments received on or before July 25, 2023, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is canceled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-2438 for ``Medical Imaging Drugs Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
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.'' FDA 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 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 the 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: Rhea Bhatt, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected], or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last-minute modifications that impact a
previously

announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check
FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link or call
the advisory committee information line to learn about possible
modifications before the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. The committee will discuss dosimetry data needed
to support the initial clinical study in an original investigational
new drug (IND) application for certain new positron emission tomography
(PET) drugs. FDA would like to obtain the committee's input on the
following: (1) the sufficiency of available data from animal or human
studies involving certain positron emitting radionuclides (e.g., C11,
F18) to allow a reasonable calculation of radiation-absorbed dose to
the whole body and critical organs upon administration of a new PET
drug containing certain radionuclides to a human subject in first-in-
human studies; and (2) the reasonableness of a proposed list of
numerical radioactivity thresholds for new PET drugs containing these
radionuclides, such that Phase 1 studies that will both (a) administer
sub-threshold activities and (b) obtain sufficient human data for
dosimetry calculations may be found safe-to-proceed in the absence of
dosimetry data based on prior animal administration of the new PET drug
under investigation.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before July 25, 2023, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 3 p.m. and 4 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 17, 2023. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 18, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Rhea Bhatt (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and the ends of justice will be served by
allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14460 Filed 7-7-23; 8:45 am]
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