[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Notices]
[Pages 20267-20268]
[FR Doc No: 2020-07527]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-10007-71-OMS]

Request for Nominations to the National and Governmental Advisory
Committees to the U.S. Representative to the Commission for
Environmental Cooperation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Request for Nominations.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA) is inviting
nominations from a diverse range of qualified candidates to be
considered for appointment to fill vacancies on the National Advisory
Committee (NAC) and the Governmental Advisory Committee (GAC) to the
U.S. Representative to the Commission for Environmental Cooperation
(CEC). Vacancies on these two committees are expected to be selected by
the spring of 2020. Please submit nominations by May 8, 2020.
Additional sources may be utilized in the solicitation of nominees.

SUPPLEMENTARY INFORMATION: The National Advisory Committee and the
Governmental Advisory Committee advise the EPA Administrator in his
capacity as the U.S. Representative to the CEC Council. The Committees
are authorized under Articles 17 and 18 of the North American Agreement
on Environmental Cooperation (NAAEC). Implementation Act, Public Law
103-182, and as directed by Executive Order 12915, entitled ``Federal
Implementation of the North American Agreement on Environmental
Cooperation.'' The NAC and GAC are continued under the authority of
Executive Order 13889, dated September 27, 2019, and operates under the
provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App.
2. The Committees are responsible for providing advice to the United
States Representative on a wide range of strategic, scientific,
technological, regulatory and economic issues related to implementation
and further elaboration of the NAAEC. The National Advisory Committee
consists of 15 representatives from environmental non-profit groups,
business and industry, and educational institutions. The Governmental
Advisory Committee consists of 14 representatives from state, local,
and tribal governments. Members are appointed by the EPA Administrator
for a two-year term. The committees usually meet 3 times per year and
the average workload for committee members is approximately 10 to 15
hours per month. Members serve on the committees in a voluntary
capacity.
    Although we are unable to provide compensation or an honorarium for
your services, you may receive travel and per diem allowances,
according to applicable federal travel regulations. EPA is seeking
nominations from various sectors, i.e., for the NAC we are seeking
nominees from academia, business and industry, and non-governmental
organizations; for the GAC we are seeking nominees from state, local
and tribal government sectors. Nominees will be considered according to
the mandates of FACA, which requires committees to maintain diversity
across a broad range of constituencies, sectors, and groups. EPA values
and welcomes diversity. In an effort obtain nominations of diverse
candidates, EPA encourages nominations of women and men of all racial
and ethnic groups. The following criteria will be used to evaluate
nominees:
     Professional knowledge of the subjects examined by the
committees, including trade & environment issues, the USMCA and ECA,
the NAFTA and NAAEC, and the CEC.
     Represent a sector or group involved in trilateral
environmental policy issues.
     Senior-level experience in the sectors represented on both
committees.
     A demonstrated ability to work in a consensus building
process with a wide range of representatives from diverse
constituencies.
    Nominations must include a resume and a short biography describing
the professional and educational qualifications of the nominee, as well
as the nominee's current business address, email address, and daytime
telephone number. Interested candidates may self-nominate. Anyone
interested in being considered for nomination is encouraged to submit
their application materials by May 8, 2020. To help the Agency in
evaluating the effectiveness of its outreach efforts, please tell us
how you learned of this opportunity. Please be aware that EPA's policy
is that, unless otherwise prescribed by statute, members generally are
appointed for two-year terms.
ADDRESSES: Submit nominations to: Oscar Carrillo, Designated Federal
Officer, Office of Diversity, Advisory Committee Management and
Outreach, U.S. Environmental Protection Agency (1601-M), 1200
Pennsylvania Avenue NW, Washington, DC 20460. You may also email
nominations with subject line COMMITTEE RESUME 2020 to
<EMAIL_ADDRESS>

FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Designated Federal
Officer, U.S. Environmental Protection Agency (1601-M), Washington, DC
20460; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Dated: April 6, 2020.
Oscar Carrillo,
Program Analyst.
[FR Doc. 2020-07527 Filed 4-9-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Rules and Regulations]
[Pages 57729-57730]
[FR Doc No: 2015-24186]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0113; FRL-9934-53-Region 4]

Air Plan Approval; GA; Removal of Stage II Gasoline Vapor
Recovery Program

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is approving changes
to the Georgia State Implementation Plan (SIP) submitted by the State
of Georgia, through the Georgia Environmental Protection Division, on
January 22, 2015, to remove Stage II vapor control requirements for new
and upgraded gasoline dispensing facilities in the State and to allow
for the decommissioning of existing Stage II equipment.

DATES: This rule will be effective October 26, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2015-0113. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section (formerly Regulatory
Development Section), Air Planning and Implementation Branch (formerly
Air Planning Branch), Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Pesticides
and Toxics Management Division, Region 4, U.S. Environmental Protection
Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms.
Sheckler's telephone number is<PHONE_NUMBER>. She can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 13, 1992, the State of Georgia submitted a SIP revision
to address the Stage II requirements \1\ for the Atlanta 1-Hour Ozone
Area.\2\ EPA approved that SIP revision, containing Georgia's Stage II
rule (Georgia Rule 391-3-1-.02(2)(zz)--Gasoline Dispensing Facilities--
Stage II) in a notice published on February 2, 1996. See 61 FR 3819. On
January 22, 2015, the State submitted a SIP revision to EPA with a
request to remove its Stage II rule from the Georgia SIP thereby
eliminating Stage II vapor control requirements for new and upgraded
gasoline dispensing facilities in the State and allowing for the
decommissioning of existing Stage II equipment. EPA published a
proposed rulemaking on July 16, 2015, to approve that SIP revision. The
details of Georgia's submittal and the rationale for EPA's action are
explained in the NPR. See 80 FR 42076. The comment period for this
proposed rulemaking closed on August 17, 2015. EPA did not receive any
comments, adverse or otherwise, during the public comment period.
---------------------------------------------------------------------------

    \1\ Stage II is a system designed to capture displaced vapors
that emerge from inside a vehicle's fuel tank, when gasoline is
dispensed into the tank. There are two basic types of Stage II
systems, the balance type and the vacuum assist type.
    \2\ On November 6, 1991, EPA designated the following counties
in and around metropolitan Atlanta as a serious ozone nonattainment
area for the 1-hour ozone NAAQS (referred to as the ``Atlanta 1-Hour
Ozone Area''): Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas,
Fayette, Forsyth, Fulton, Gwinnett, Henry, Paulding, and Rockdale.
56 FR 56694. The ``serious'' classification triggered various
statutory requirements for the Atlanta 1-Hour Ozone Area, including
the requirement pursuant to section 182(b)(3) of the CAA for the
Area to require all owners and operators of gasoline dispensing
systems to install and operate Stage II. EPA redesignated the
Atlanta 1-Hour Ozone Area to attainment for the 1-hour ozone NAAQS,
effective June 14, 2005. See 70 FR 34660 (June 15, 2005).
---------------------------------------------------------------------------

II. Final Action

    EPA is taking final action to approve the January 22, 2015, SIP
revision submitted by Georgia and remove Georgia Rule 391-3-
1-.02(2)(zz) from the SIP. This action removes Stage II vapor control
requirements for new and upgraded gasoline dispensing facilities and
allows for the decommissioning of existing Stage II equipment. EPA has
determined that Georgia's January 22, 2015, SIP revision related to the
State's Stage II rules is consistent with the CAA and EPA's regulations
and guidance.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:

 Is not a ``significant regulatory action'' subject to review
by the Office of Management and Budget under Executive Order 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
 Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

 Is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);
 Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
 Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
 Is not an economically significant regulatory action based on
health or safety risks subject to Executive Order 13045 (62 FR 19885,
April 23, 1997);
 Is not a significant regulatory action subject to Executive
Order 13211 (66 FR 28355, May 22, 2001);
 Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
 Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 24, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: September 10, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart L--Georgia

0
2. In Sec.  52.570, the table in paragraph (c) is amended by removing
the entry for ``391-3-1-.02(2)(zz).''
[FR Doc. 2015-24186 Filed 9-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 5 (Thursday, January 8, 2015)]
[Notices]
[Pages 1067-1068]
[FR Doc No: 2015-00045]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2014-148]

Petition for Exemption; Summary of Petition Received; Brandau,
Jerry

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before January 28, 2015.

ADDRESSES: Send comments identified by docket number FAA-2014-1016
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in

Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>. 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on January 2, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-1016.
    Petitioner: Brandau, Jerry.
    Section(s) of 14 CFR Affected: Sec. Sec.  103.1(a) and (b), and
103.21.
    Description of Relief Sought: The petitioner is requesting relief
to commercially operate its Phantom 2 Vision plus, small lightweight
unmanned aircraft system (UAS), as an ultralight vehicle, for aerial
photography, agriculture field inspection, and aerial property
monitoring.

[FR Doc. 2015-00045 Filed 1-7-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24313-24316]
[FR Doc No: 2022-08728]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0081]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tradeoff Analysis of Prescription Drug Product Claims
in Direct-to-Consumer and Healthcare Provider Promotion

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled ``Tradeoff Analysis of
Prescription Drug Product Claims in Direct-to-Consumer and Healthcare
Provider Promotion.''

DATES: Submit either electronic or written comments on the collection
of information by June 24, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 24, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0081 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tradeoff Analysis of Prescription
Drug Product

Claims in Direct-to-Consumer and Healthcare Provider Promotion.''
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: Regarding the information collection:
Jonna 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]. For copies of the
questionnaire: Office of Prescription Drug Promotion (OPDP) Research
Team, [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 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.

Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-
Consumer and Healthcare Provider Promotion

OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first and second topic areas, advertising
features and target populations.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved by using the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our home page,
which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    The proposed research examines the relative importance of
prescription drug product information such as prescription drug
efficacy, risk, adherence, and patient preference claims in two medical
conditions (type 2 diabetes and psoriasis) in consumer and physician
samples. When confronted with an important decision, people tend to
make choices that reflect a series of tradeoffs between certain
desirable and undesirable attributes of a product, service, or
experience. Pharmaceutical manufacturers provide information about
prescription drug products, including side effects, contraindications,
and effectiveness through product labeling and promotional materials
(21 CFR 202.1(e)).

The treatment preferences of diagnosed consumers and treating
physicians have been shown to be influenced by certain characteristics,
such as the perceived drug's impact on quality of life, complexity of
dosage regimens, mode of administration, cost to family and self, and
marketing claims unrelated to medicinal properties (Refs. 1 to 5).
Although diagnosed consumers may weigh the risks, benefits, or other
salient characteristics of prescription drug products differently than
physicians, little research directly compares the treatment preferences
of these two groups (Ref. 6). Understanding the tradeoffs among drug
product characteristics diagnosed consumers make--and how the tradeoffs
could potentially differ from the tradeoffs made by physicians--will
provide valuable insight into the relevance and impact of various
product attributes and promotional claims on informed choices and
treatment decisions.
    We intend to examine these tradeoffs using a choice-based conjoint
analysis, also known as a discrete choice experiment. Conjoint analysis
is a broad class of survey-based techniques used to estimate how
attractive or influential different features of choice options or
product attributes are in determining purchase behavior or treatment
choices (Ref. 7). Conjoint analysis can be used to examine the joint
effects and tradeoffs of multiple variables or product attributes on
decisions. A choice-based conjoint analysis is based on the principle
that products are composed of a set of attributes, and each attribute
can be described using a finite number of levels. In the proposed
research, participants will be shown a carefully designed sequence of
choice tasks containing up to five hypothetical product attributes--in
this case, profiles describing fictitious prescription drug products
for either type 2 diabetes or psoriasis. Using data from the choices
that participants make across these tasks, we can use statistical
techniques to draw inferences about the relative value they place on
different product attributes, estimate the relative importance of
different attributes, explore the tradeoffs that consumers and
physicians are willing to make to avoid or accept specific attribute
levels, and compare the preferences of these two groups (Ref. 8).
    We estimate that participation in the study will take approximately
20 minutes. Adult participants aged 18 years or older will be recruited
by email through an internet panel, and participant eligibility will be
determined with a screener at the beginning of the online survey. The
consumer sample will consist of adults who self-report as having been
diagnosed by a healthcare provider with either psoriasis or type 2
diabetes. For the consumer sample, we will exclude individuals who work
in healthcare settings because their knowledge and experiences may not
reflect those of the average consumer. The physician sample will
consist of primary care physicians and specialists who report treating
patients with psoriasis or type 2 diabetes. For the physician sample,
we will exclude individuals who spend less than 50 percent of their
time on direct patient care. Department of Health and Human Services
employees and individuals who work in the marketing, advertising, or
pharmaceutical industries will be excluded from both respondent groups.
Respondents will receive a survey invitation with a unique password
protected link. All panel members are recruited following a double opt-
in process. Sample sizes were estimated by combining approaches for
conjoint analysis suggested by Orme (Ref. 9) and Johnson et al. (Ref.
10).
    The target sample size for the main study is 800 physicians and 800
consumers, with half of each cohort focusing on treatments for
psoriasis and the other half focusing on treatments for type 2
diabetes. Prior to conducting the main study, we will conduct at least
one pretest. If the first pretest reveals that changes to the
measurement instruments, stimuli, or procedures are required, a second
pretest will be conducted with revised materials. The target sample
size for each wave of pretests is 60 physicians and 60 consumers.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
           Activity                Number of     responses per   Total annual     per  response     Total hours
                                  respondents   respondent \2\     responses           \3\
----------------------------------------------------------------------------------------------------------------
Pretest 1 Screener, Physicians              95               1              95  0.08 (5 minutes)               8
 \4\.
Pretest 1 Screener, Consumers               95               1              95  0.08 (5 minutes)               8
 \4\.
Physician Pretest 1...........              66               1              66  0.33 (20                      22
                                                                                minutes).
Consumer Pretest 1............              66               1              66  0.33 (20                      22
                                                                                minutes).
Pretest 2 Screener, Physicians              95               1              95  0.08 (5 minutes)               8
 4 5.
Pretest 2 Screener, Consumers               95               1              95  0.08 (5 minutes)               8
 4 5.
Physician Pretest 2 \4\.......              66               1              66  0.33 (20                      22
                                                                                minutes).
Consumer Pretest 2 \4\........              66               1              66  0.33 (20                      22
                                                                                minutes).
Physician Main Study Screener            1,258               1           1,258  0.08 (5 minutes)             101
 \4\.
Physician Main Study..........             880               1             880  0.33 (20                     290
                                                                                minutes).
Consumer Main Study Screener             1,258               1           1,258  0.08 (5 minutes)             101
 \4\.
Consumer Main Study...........             880               1             880  0.33 (20                     290
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............           4,920  ................             902
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of
  completing the survey when the target number is reached and that those surveys will be completed and received
  before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
  both samples in the study.
\3\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\4\ Number of screener respondents assumes a 70 percent eligibility rate with targeted recruitment.
\5\ Pretest 2 will be conducted only if changes to study materials are made in response to the findings of
  Pretest 1.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Aikin, K.J., K.R. Betts, K.S. Ziemer, et al. (2019). ``Consumer
Tradeoff of Advertising Claim Versus Efficacy Information in Direct-
to-Consumer Prescription Drug Ads.'' Research in Social and
Administrative Pharmacy, 15(12), 1484-1488. https://doi.org/10.1016/j.sapharm.2019.01.012.
*2. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, et al. (2017).
``Conjoint Analysis to Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying Therapy Attributes in
Spain: A Cross-Sectional Observational Study.'' BMJ Open, 7(3),
e014433. https://doi.org/10.1136/bmjopen-2016-014433.
3. Fraenkel, L., L. Suter, C.E. Cunningham, et al, (2014).
``Understanding Preferences for Disease-Modifying Drugs in
Osteoarthritis.'' Arthritis Care & Research, 66(8), 1186-1192.
https://pubmed.ncbi.nlm.nih.gov/24470354/.
4. Katz, D.A., C. Hamlin, M.W. Vander Weg, et al. (2020).
``Veterans' Preferences for Tobacco Treatment in Primary Care: A
Discrete Choice Experiment.'' Patient Education and Counseling,
103(3), 652-660. https://doi.org/10.1016/j.pec.2019.10.002.
5. Wouters, H., G.A. Maatman, L. Van Dijk, et al. (2013). ``Trade-
Off Preferences Regarding Adjuvant Endocrine Therapy Among Women
With Estrogen Receptor-Positive Breast Cancer.'' Annals of Oncology,
24(9), 2324-2329. https://doi.org/10.1093/annonc/mdt195.
6. Gregorian, Jr., R.S., A. Gasik, W.J. Kwong, et al. (2010).
``Importance of Side Effects in Opioid Treatment: A Trade-Off
Analysis With Patients and Physicians.'' The Journal of Pain,
11(11), 1095-1108. https://doi.org/10.1016/j.jpain.2010.02.007.
7. Johnson, FR, E. Lancsar, D. Marshall, et al. (2013).
``Constructing Experimental Designs for Discrete-Choice Experiments:
Report of the ISPOR Conjoint Analysis Experimental Design Good
Research Practices Task Force.'' Value in Health, 16(1), 3-13.
https://doi.org/10.1016/j.jval.2012.08.2223.
8. Bridges, J.F.P., A.B. Hauber, D. Marshall, et al. (2011).
``Conjoint Analysis Applications in Health--A Checklist: A Report of
the ISPOR Good Research Practices for Conjoint Analysis Task
Force.'' Value in Health, 14(4), 403-413. https://doi.org/10.1016/j.jval.2010.11.013.
9. Orme, B. (2019). Getting Started With Conjoint Analysis:
Strategies for Product Design and Pricing Research (Fourth ed.).
Madison, WI: Research Publishers LLC.
10. Johnson, F., B. Kanninen, M. Bingham, et al. (2006).
``Experimental Design for Stated-Choice Studies.'' In: Valuing
Environmental Amenities Using Stated Choice Studies (pp. 159-202).
B.J. Kanninen (Ed.). Dordrecht: Springer.

    Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08728 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Notices]
[Pages 1106-1110]
[FR Doc No: 2021-00023]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-10016-84-OAR]

Official Release of the MOVES3 Motor Vehicle Emissions Model for
SIPs and Transportation Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the MOtor Vehicle Emission Simulator model (MOVES3) for
official purposes outside of California. MOVES3 is the latest state-of-
the art upgrade to EPA's modeling tools for estimating emissions from
cars, trucks, buses, and motorcycles based on the latest data and
regulations. MOVES3 is available for use in state implementation plans
(SIPs) and transportation conformity analyses outside of California.
This notice starts a two-year grace period before MOVES3 will need to
be used as the latest EPA emissions model in new regional emissions
analyses and a two-year grace period before MOVES3 will need to be used
in new hot-spot analyses for transportation conformity determinations
outside of California.

DATES: EPA's announcement of the MOVES3 emissions model for SIPs and
transportation conformity analyses in states other than California is
effective January 7, 2021. This announcement starts a two-year
transportation conformity grace period that ends on January 9, 2023.
After this date, MOVES3 will need to be used as the latest EPA
emissions model in both regional emissions analyses and in hot-spot
analysis for new transportation conformity analyses outside of
California.

FOR FURTHER INFORMATION CONTACT: For technical model questions
regarding the official release or use of MOVES3, please email EPA at
<EMAIL_ADDRESS>For questions about SIPs, contact Rudy Kapichak at
<EMAIL_ADDRESS>734-214-4574. For transportation conformity
questions, contact Astrid Terry at<EMAIL_ADDRESS>734-214-4812.

SUPPLEMENTARY INFORMATION: The contents of this notice are as follows:

I. General Information
II. What is MOVES3?
III. SIPs and MOVES3
IV. Transportation Conformity and MOVES3

I. General Information

A. Does this action apply to me?

    Entities potentially impacted by the approval of MOVES3 are those
that adopt, approve, or fund transportation plans, transportation
improvement programs (TIPs), or projects under title 23 U.S.C. or title
49 U.S.C. Chapter 53 and those that develop and submit SIPs to EPA.
Regulated categories and entities affected by today's action include:

------------------------------------------------------------------------
                Category                 Examples of regulated  entities
------------------------------------------------------------------------
Local government.......................  Local air quality and
                                          transportation agencies,
                                          including metropolitan
                                          planning organizations (MPOs).
State government.......................  State air quality and
                                          transportation agencies.
Federal government.....................  Department of Transportation
                                          (Federal Highway
                                          Administration (FHWA) and
                                          Federal Transit Administration
                                          (FTA)).
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by the
release of MOVES. Other entities not listed in the table could also be
affected. To determine whether your organization is affected by this
action, you should carefully examine the transportation conformity
applicability requirements in 40 CFR 93.102. If you have questions
regarding the applicability of this action to a particular entity,
consult the persons listed in the preceding FOR FURTHER INFORMATION
CONTACT section.

B. How can I get copies of MOVES3 and other related information?

    The official version of the MOVES3 model, along with user guides
and supporting documentation, are available on EPA's MOVES website:
www.epa.gov/moves. Individuals who wish to receive EPA announcements
related to the MOVES3 model should subscribe to the EPA-MOBILENEWS
email listserv, which can be done at EPA's website at: www.epa.gov/moves/forms/epa-mobilenews-listserv.
    Available guidance on how to apply MOVES3 for SIPs and
transportation conformity purposes can be found on EPA's transportation
conformity website, www.epa.gov/state-and-local-transportation/policy-
and-technical-guidance-state-and-local-

transportation,\1\ including ``Policy Guidance on the Use of MOVES3 for
State Implementation Plan Development, Transportation Conformity,
General Conformity, and Other Purposes'' (EPA-420-B-20-044, November
2020).\2\
---------------------------------------------------------------------------

    \1\ Interested parties can find these documents under either the
``Emission Models and Conformity'' or ``Project-Level Conformity''
topics on this website.
    \2\ This guidance, along with the other EPA guidance referenced
in this document, is listed in the EPA guidance portal at
www.epa.gov/guidance/guidance-documents-managed-office-air-and-radiation.
---------------------------------------------------------------------------

    EPA will continue to update these websites as other MOVES support
materials and guidance are developed or updated.

II. What is MOVES3?

    MOVES3 is EPA's latest motor vehicle emissions model for state and
local agencies to estimate volatile organic compounds (VOCs), nitrogen
oxides (NOx), particulate matter (PM2.5 and
PM10), carbon monoxide (CO), and other precursors from cars,
trucks, buses, and motorcycles for SIP purposes and conformity
determinations outside of California.\3\ The model is based on analyses
of millions of emission test results and considerable advances in the
Agency's understanding of vehicle emissions.
---------------------------------------------------------------------------

    \3\ MOVES can also model emissions in the District of Columbia,
Puerto Rico, and the U.S. Virgin Islands. Nonattainment and
maintenance areas located in California use the latest approved
version of the Emission FACtor (EMFAC) model.
---------------------------------------------------------------------------

    The first model in the MOVES series, called MOVES2010, was released
in December of 2009. MOVES2010 was followed by two minor updates,
MOVES2010a and MOVES2010b. Both of these minor MOVES2010 revisions
enhanced model performance. MOVES2014, released in 2014, was a major
revision to MOVES2010b and included new data, new emissions standards,
and new functional improvements and features. It incorporated
substantial new data for emissions, fleet, and activity developed since
the release of MOVES2010. MOVES2014 was also followed by two minor
updates, MOVES2014a and MOVES2014b.\4\
---------------------------------------------------------------------------

    \4\ In the remainder of this notice, ``MOVES2014'' refers to all
of the MOVES2014 models: MOVES2014, MOVES2014a, and MOVES2014b.
---------------------------------------------------------------------------

    MOVES3 incorporates new regulations, features and significant new
data, as detailed in the MOVES3 technical reports. Notably, MOVES3
incorporates:
     Improvements to heavy-duty (HD) diesel running emission
rates based on manufacturer in-use testing data from hundreds of HD
trucks;
     Updated emission rates for HD gasoline and compressed
natural gas (CNG) trucks;
     Updated light-duty (LD) vehicle emission rates for
hydrocarbons (HC), CO and NOx-based on in-use testing data;
     Updated LD PM rates for Model Year (MY) 2004 and later,
incorporating data on gasoline direct injection engines;
     New fuel characteristic data from EPA fuel compliance
submissions;
     Updated fuel effect calculations to better characterize
the base fuel used to develop LD base emission rates;
     The effects of the HD Phase 2 GHG rule; \5\
---------------------------------------------------------------------------

    \5\ 81 FR 7348, October 25, 2016.
---------------------------------------------------------------------------

     The effects of the Safer Affordable Fuel-Efficient (SAFE)
Vehicles Rule on light-duty fuel economy; \6\
---------------------------------------------------------------------------

    \6\ 85 FR 24174, April 30, 2020.
---------------------------------------------------------------------------

     ``Off-network idle'' emissions beyond the idling that is
already considered in the MOVES drive cycles; and
     Several improvements to the MOVES interface, user inputs
and outputs.
    MOVES3 also includes a variety of activity updates, most notably:
     Vehicle start and idling activity patterns are based on
real-world instrumented vehicle data collected by a telecommunications
company for LD vehicles and the Department of Energy's (DOE) National
Renewable Energy Lab (NREL) for HD vehicles;
     Default hotelling activity has been substantially reduced
from what was included in MOVES2014 based on the NREL instrumented
truck data;
     National vehicle miles travelled (VMT) and vehicle
population inputs have been updated with newer historical data from the
Federal Highway Administration (FHWA) and more recent forecasts from
DOE; and
     National onroad vehicle default fuel, regulatory class,
and age distributions are based on newer vehicle registration data.
    MOVES3 includes the capability to estimate vehicle exhaust and
evaporative emissions as well as brake wear and tire wear emissions for
criteria pollutants and precursors. However, MOVES3 does not include
the capability to estimate emissions of re-entrained road dust. To
estimate emissions from re-entrained road dust, practitioners should
continue to use the latest approved methodologies.\7\
---------------------------------------------------------------------------

    \7\ See EPA's notice of availability, ``Official Release of the
January 2011 AP-42 Method for Estimating Re-Entrained Road Dust from
Paved Roads,'' published in the Federal Register on February 4, 2011
(76 FR 6328).
---------------------------------------------------------------------------

    The structure of MOVES3 is fundamentally the same as MOVES2014,
although there are new format options for some inputs, and the model
run time may differ depending on the type of run and user inputs and
computer configuration. As for emissions, EPA performed a comparison of
MOVES3 to MOVES2014b using default information in MOVES3 at the
national level, and for two sample urban counties with different local
travel patterns and ambient conditions. In general, compared to
MOVES2014b, MOVES3 national emission estimates are slightly lower for
most criteria pollutants in future years. However, in the two sample
urban counties, NOX emissions estimates were higher in
future years. This is due to higher running emissions from heavy-duty
trucks outweighing declines from heavy-duty hotelling. Note that
results will vary based on the pollutant selected and that area's local
inputs. Based on our testing, MOVES run time at the Default and County
Scale should be about the same or faster than runs with MOVES2014b. In
addition, MOVES3 run time at the Project Scale may be notably longer
compared to MOVES2014 depending on the type of run, user inputs and
computer configuration.

III. SIPs and MOVES3

    EPA has articulated its policy regarding the use of MOVES3 in SIP
development in its ``Policy Guidance on the Use of MOVES3 for State
Implementation Plan Development, Transportation Conformity, General
Conformity and Other Purposes'' (EPA-420-B-20-044, November 2020).
Today's notice highlights certain aspects of the guidance, but state
and local governments should refer to the guidance for more detailed
information on how and when to use MOVES3 in reasonable further
progress SIPs, attainment demonstrations, maintenance plans, inventory
updates, and other SIP submissions.
    MOVES3 should be used in ozone, CO, PM, and nitrogen dioxide
(NO2) SIP development as expeditiously as possible, as there
is no grace period for the use of MOVES3 in SIPs. The Clean Air Act
requires that SIP inventories and control measures be based on the most
current information and applicable models that are available when a SIP
is developed.\8\ However, EPA also

recognizes the time and level of effort that certain states may have
already undertaken in SIP development using a version of MOVES2014.
States should consult with their EPA Regional Office if they have
questions about how MOVES3 affects SIPs under development in specific
nonattainment or maintenance areas. Early consultation can facilitate
EPA's adequacy finding for SIP motor vehicle emissions budgets for
transportation conformity purposes or EPA's SIP approval.
---------------------------------------------------------------------------

    \8\ See Clean Air Act section 172(c)(3). Also see the discussion
of emissions inventory requirements in the ``Fine Particulate Matter
National Ambient Air Quality Standards: State Implementation Plan
Requirements'' rule (81 FR 58029, August 24, 2016) and in the
``Implementation of the 2015 National Ambient Air Quality Standards
for Ozone: Nonattainment Area State Implementation Plan
Requirements'' rule (83 FR 63022, December 6, 2018).
---------------------------------------------------------------------------

    States should use the latest version of MOVES that is available at
the time that a SIP is developed. All states other than California
should use MOVES3 for SIPs that will be submitted in the future so that
they are based on the most accurate estimates of emissions possible.
However, state and local agencies that have already completed
significant work on a SIP with a version of MOVES2014 (e.g., attainment
modeling has already been completed with MOVES2014) may continue to
rely on the earlier version of MOVES. It would be unreasonable to
require the states to revise these SIPs with MOVES3 since significant
work has already occurred based on the latest information available at
the time the SIP was developed, and EPA intends to act on these SIPs in
a timely manner.
    The Clean Air Act does not require states that have already
submitted SIPs or will submit SIPs shortly after the release of a new
model to revise these SIPs simply because a new motor vehicle emissions
model is now available.\9\ States can choose to use MOVES3 in these
SIPs, for example, if it is determined that it is appropriate to update
motor vehicle emissions budgets (``budgets'') with the model for future
conformity determinations. However, as stated above, states should use
MOVES3 where SIP development is in its initial stages or has not
progressed far enough along that switching from a previous model
version would create a significant adverse impact on state resources.
---------------------------------------------------------------------------

    \9\ Sierra Club v. EPA, 356 F.3d. 296, 308 (DC Cir. 2004) (``To
require states to revise completed plans every time a new model is
announced would lead to significant costs and potentially endless
delays in the approval processes.'')
---------------------------------------------------------------------------

    Incorporating MOVES3 into the SIP now could assist areas in
mitigating possible transportation conformity difficulties in the
future after the MOVES3 conformity grace period ends. New regional
emissions analyses using EPA's emissions model that are started after
the grace period is over must be based on MOVES3 (40 CFR 93.111), so
having MOVES3-based SIP budgets in place at that time could provide
more consistency with transportation conformity determinations.

IV. Transportation Conformity and MOVES3

    In today's notice, EPA is announcing the availability of MOVES3 for
use in transportation conformity analyses outside of California. EPA is
also establishing a two-year grace period before MOVES3 will need to be
used in regional emissions analysis for transportation conformity
determinations and in hot-spot analyses for project-level
transportation conformity determinations which use EPA's emissions
model. The MOVES3 grace period for regional emissions and hot-spot
analyses applies to the use of MOVES3 and any future minor revisions
that occur during the grace period.
    Transportation conformity is a Clean Air Act requirement to ensure
that federally supported highway and transit activities are consistent
with (``conform to'') the SIP. Conformity to a SIP means that a
transportation activity will not cause or contribute to new air quality
violations; worsen existing violations; or delay timely attainment of
national ambient air quality standards or any interim milestones.
Transportation conformity applies in nonattainment and maintenance
areas for transportation-related pollutants: Ozone, CO,
PM2.5, PM10 and NO2. EPA's
transportation conformity regulations (40 CFR parts 51.390 and 93
Subpart A) describe how federally funded and approved highway and
transit projects meet these statutory requirements.
    The remainder of this section describes how the transportation
conformity grace period was determined and summarizes how it will be
implemented, including those circumstances when the grace period could
be shorter than two years for regional emissions analyses. However, for
complete explanations of how MOVES3 is to be implemented for
transportation conformity, including details about using MOVES3 during
the grace period, refer to ``Policy Guidance on the Use of MOVES3 for
State Implementation Plan Development, Transportation Conformity,
General Conformity and Other Purposes'' (EPA-420-B-20-044).

A. Why is EPA establishing a two-year conformity grace period?

    Section 176(c)(1) of the Clean Air Act states that ``. . .[t]he
determination of conformity shall be based on the most recent estimates
of emissions, and such estimates shall be determined from the most
recent population, employment, travel, and congestion estimates. . .''.
Additionally, the transportation conformity rule (40 CFR 93.111)
requires conformity analyses to be based on ``the latest emissions
estimation model available,'' and further states that this requirement
is satisfied if the most current version of EPA's motor vehicle
emissions model is used. When EPA announces a new emissions model, such
as MOVES3, we establish a grace period before the model needs to be
used for transportation conformity purposes (40 CFR 93.111(b)). In
consultation with DOT, EPA must consider the degree of change in the
emissions model and the effects of the new model on the transportation
planning process (40 CFR 93.111(b)(2)). The transportation conformity
rule provides that EPA will establish a grace period for new emissions
models of between three and 24 months (40 CFR 93.111(b)(1)).
    EPA articulated its intentions for establishing the length of a
conformity grace period in the preamble to the 1993 transportation
conformity rule (November 24, 1993; 58 FR 62211):
    ``EPA and DOT [the Department of Transportation] will consider
extending the grace period if the effects of the new emissions model
are so significant that previous SIP demonstrations of what emission
levels are consistent with attainment would be substantially affected.
In such cases, States should have an opportunity to revise their SIPs
before MPOs must use the model's new emissions factors.''
    In consultation with DOT, EPA considered the degree of change in
MOVES3 and the effects of the new model on the transportation planning
process (40 CFR 93.111(b)(2)). EPA considered the time it will take
state and local transportation and air quality agencies to conduct and
provide technical support for analyses. State and local agencies will
need to become familiar with the MOVES3 emissions model and may need to
convert existing data for use in MOVES3. Since 1993, the fundamental
purpose of section 93.111(b) of the transportation conformity rule has
been to provide a sufficient amount of time for MPOs and other state
and local agencies to learn and employ new emissions models. The
transition to a new emissions model for conformity involves more than
learning to use the new model and preparing input data and model
output. After model start-up is complete, state and local agencies also
need to consider how the model affects regional emissions analysis
results and whether SIP and/or

transportation plan/TIP changes are necessary to assure future
conformity determinations.
    The two-year conformity grace period also provides sufficient time
for state and local agencies to learn and apply new technical guidance
and training courses that reflect MOVES3. EPA is working to update
guidance documents and training courses as quickly as possible. EPA
will notify MOVES3 users when these important materials are available.
Training courses are anticipated to be provided in the form of webinars
and other courses and address different levels of State and local
expertise.
    In addition, many agencies will be implementing the transition to
PM and CO hot-spot analyses with MOVES3 for applicable projects in
those nonattainment and maintenance areas, with each analysis
potentially involving multiple state and local agencies. States with CO
hot-spot protocols that were previously approved into the SIP (40 CFR
93.123(a)(1)) that are based on a previous model will need time to
revise them. Additional time is necessary to revise previously approved
CO hot-spot protocols, and the SIP revision process and state
requirements can vary. Finally, EPA considered the general time and
monetary resource constraints in which state and local agencies
currently operate. Upon considerations of all these factors, EPA is
establishing a two-year grace period, which begins today and ends on
January 9, 2023, before MOVES3 needs to be used for new transportation
conformity analyses outside of California.

B. Circumstances When Grace Period Will Be Shorter Than Two Years

    The grace period for regional emissions analyses will be shorter
than two years for a given pollutant if an area revises its SIP and
motor vehicle emissions budgets with MOVES3 and such budgets have been
found adequate or approved into the SIP prior to the end of the two-
year grace period. In this case, the new regional emissions analysis
must use MOVES3 if the conformity determination is based on a MOVES3-
based budget (40 CFR 93.111).
    Areas that are designated nonattainment or maintenance for multiple
pollutants may rely on both MOVES3 and MOVES2014 to determine
conformity for different pollutants during the grace period. For
example, if an area revises a previously submitted (but not approved)
MOVES2014-based PM10 SIP with MOVES3 and EPA finds these
revised MOVES3 budgets adequate for conformity, such budgets would
apply for conformity on the effective date of the Federal Register
notice announcing EPA's adequacy finding. In this example, if the area
is nonattainment for PM10 and ozone, the MOVES3 grace period
would end for PM10 regional emissions analyses once EPA
found the new MOVES3-based SIP budgets adequate. However, MOVES2014
could continue to be used for ozone-related regional emissions analyses
begun before the end of the MOVES3 grace period.\10\ In addition, the
length of the grace period for hot-spot analyses would not be affected
by an early submission of MOVES3-based budgets. In this example, the
two-year grace period for PM10 hot-spot analyses would
continue to apply even if the grace period is shortened for regional
PM10 conformity analyses. EPA Regional Offices should be
consulted for questions regarding such situations in multi-pollutant
areas.
---------------------------------------------------------------------------

    \10\ In this example, such an area would use MOVES3 to develop a
regional emissions analysis for PM10 for comparison to
the revised MOVES3-based budgets (e.g., PM10 budgets).
The regional emissions analysis for ozone could be based on
MOVES2014 for the VOC and NOx budgets in the ozone SIP for the
remainder of the conformity grace period.
---------------------------------------------------------------------------

    In addition, in most cases, if the state revises previously
approved budgets based on an earlier EPA emissions model, the revised
MOVES3 budgets could not be used for conformity purposes until EPA
approves them, i.e., approves the SIP revision. In general, submitted
SIPs cannot supersede approved budgets until the submitted SIP is
approved. See 40 CFR 93.118(e)(1).
    However, 40 CFR 93.118(e)(1) allows an approved budget to be
replaced by an adequate budget if EPA's approval of the initial budgets
specifies that the budgets being approved may be replaced in the future
by new adequate budgets. This flexibility has been used in limited
situations in the past. In such cases, the MOVES3-based budgets would
be used for conformity purposes once they have been found adequate, if
requested by the state in its SIP submission and specified in EPA's SIP
approval. States should consult with their EPA Regional Office to
determine if this flexibility applies to their situation.

C. Use of MOVES3 for Regional Emissions Analyses During the Grace
Period

    During the conformity grace period, areas should use interagency
consultation to examine how MOVES3 will impact their future
transportation plan and TIP conformity determinations, including
regional emissions analyses. Isolated rural areas should also consider
how future regional emissions analyses will be affected when the MOVES3
grace period ends. Areas should carefully consider whether the SIP and
budgets should be revised with MOVES3 or if transportation plans and
TIPs should be revised before the end of the conformity grace period,
since doing so may be necessary to ensure conformity in the future.
    Finally, the transportation conformity rule provides flexibility
for completing conformity determinations based on regional emissions
analyses that use MOVES2014 that are started before the end of the
grace period. Regional emissions analyses that are started during the
grace period can use either MOVES2014 or MOVES3. The interagency
consultation process should be used if it is unclear if a MOVES2014-
based analysis was begun before the end of the grace period. If there
are questions about which model should be used in a conformity
determination, the EPA Regional Office can be consulted.
    When the grace period ends on January 9, 2023, MOVES3 will become
the only EPA motor vehicle emissions model for regional emissions
analyses for transportation conformity in states other than California.
In general, this means that all new transportation plan and TIP
conformity determinations started after the end of the grace period
must be based on MOVES3, even if the SIP is based on MOVES2014 or an
older version of the MOVES model.

D. Use of MOVES3 for Project-Level Hot-Spot Analyses During the
Conformity Grace Period

    The MOVES3 grace period also applies to the use of MOVES3 for CO,
PM10 and PM2.5 hot-spot analyses. Sections 93.116
and 93.123 of the transportation conformity regulation contain the
requirements for when a hot-spot analysis is required for project-level
conformity determinations.\11\ The transportation conformity rule
provides flexibility for analyses that are started before the end of
the grace period. A conformity determination for a transportation
project may be based on a previous model if the analysis was begun
before or during the grace period, and if the final environmental
document for the project is issued no more than

three years after the issuance of the draft environmental document (40
CFR 93.111(c)). Interagency consultation should be used if it is
unclear if a previous analysis was begun before the end of the grace
period. For CO, PM10 and PM2.5 hot-spot analyses
that start during the grace period, project sponsors can choose to use
MOVES2014 or MOVES3.
---------------------------------------------------------------------------

    \11\ In CO nonattainment and maintenance areas, a hot-spot
analysis is required for all non-exempt projects, with quantitative
hot-spot analyses being required for larger, congested intersections
and other projects (40 CFR 93.123(a)(1)). In addition, in
PM2.5 and PM10 nonattainment and maintenance
areas, the transportation conformity regulation requires that a
quantitative hot-spot analysis be completed for certain projects
(see 40 CFR 93.123(b)(1)).
---------------------------------------------------------------------------

    EPA encourages sponsors to use the consultation process to
determine which option may be most appropriate for a given situation.
Any new CO, PM10 or PM2.5 hot-spot analyses for
conformity purposes begun after the end of the grace period must be
based on MOVES3. EPA has guidance on how to conduct quantitative
PM2.5 and PM10 hot-spot modeling for
transportation conformity purposes, and on how to use MOVES for a CO
hot-spot analysis. EPA will be updating these guidance documents with
MOVES3; until that time, the MOVES2014-based guidance may still
generally be used for MOVES3. See EPA's ``Project-level Conformity''
website, www.epa.gov/state-and-local-transportation/project-level-conformity-and-hot-spot-analyses, for the latest information and
guidance documents on how to conduct CO, PM10 and
PM2.5 hot-spot modeling for transportation conformity
purposes.
    Any new, quantitative CO, PM10 or PM2.5 hot-
spot analysis for conformity purposes begun after the end of the grace
period using EPA's emissions model must use MOVES3. The interagency
consultation process should be used if it is unclear whether these
conditions are met. For questions about which model should be used in a
project-level conformity determination, consult with your EPA Regional
Office.

E. FHWA's CO Categorical Hot-Spot Finding

    FHWA released the most recent CO categorical hot-spot finding for
intersection projects on July 17, 2017, that was based on
MOVES2014a.\12\ During the MOVES3 grace period, a project sponsor
outside of California may continue to rely on the categorical finding
for applicable projects that are determined through interagency
consultation to be covered by the finding's parameters. Any new CO hot-
spot analyses for conformity purposes begun after the end of the MOVES3
grace period may no longer rely on the July 2017 CO categorical hot-
spot finding because the finding was based on MOVES2014.
---------------------------------------------------------------------------

    \12\ See www.epa.gov/state-and-local-transportation/project-level-conformity-and-hot-spot-analyses#cohotspot.
---------------------------------------------------------------------------

F. CO Hot-Spot Protocols That Were Previously Approved Into the SIP

    Section 93.123(a)(1) of the transportation conformity regulation
allows areas to develop alternate procedures for determining localized
CO hot-spot analyses, when developed through interagency consultation
and approved by the EPA Regional Administrator. Some states have chosen
in the past to develop such procedures based on previous EPA emissions
models.
    During the MOVES3 grace period, areas with previously approved CO
hot-spot protocols based on MOVES2014 may continue to rely on these
protocols. Once the MOVES3 two-year grace period ends, new CO hot-spot
analyses for conformity purposes will need to be based on MOVES3 and
thus may no longer rely on a CO hot-spot protocols based on MOVES2014.

    Dated: November 24, 2020.
Karl J. Simon,
Director, Transportation and Climate Division, Office of Transportation
and Air Quality.
[FR Doc. 2021-00023 Filed 1-6-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Notices]
[Pages 19215-19217]
[FR Doc No: 2020-07116]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0320; FMCSA-2017-0254]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions for four
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on March 22, 2020. The exemptions
expire on March 22, 2022. Comments must be received on or before May 6,
2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2015-0320 or FMCSA-2017-0254
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/docket?D=FMCSA-2015-0320 or http://www.regulations.gov/docket?D=FMCSA-2017-0254. Follow the online
instructions for submitting comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2015-0320; FMCSA-2017-0254), indicate the
specific section of this document to which each comment applies, and
provide a reason for each suggestion or recommendation. You may submit
your comments and material online or by fax, mail, or hand delivery,
but please use only one of these means. FMCSA recommends that you
include your name and a mailing address, an email address, or a phone
number in the body of your document so that FMCSA can contact you if
there are questions regarding your submission.
    To submit your comment online, go to: http://www.regulations.gov/docket?D=FMCSA-2015-0320 or http://www.regulations.gov/docket?D=FMCSA-2017-0254. Click on the ``Comment Now!'' button and type your comment
into the text box on the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to

know that they reached the facility, please enclose a stamped, self-
addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=2015-0320 or http://www.regulations.gov/docket?D=FMCSA-2017-0254 and choose the document to review. If you do not have access to
the internet, you may view the docket online by visiting Docket
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

    The four individuals listed in this notice have requested renewal
of their exemptions from the epilepsy and seizure disorders prohibition
in Sec.  391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable 2-
year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the
four applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The four
drivers in this notice remain in good standing with the Agency, have
maintained their medical monitoring and have not exhibited any medical
issues that would compromise their ability to safely operate a CMV
during the previous 2-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    As of March 22, 2020, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Daniel Halstead (NV)
Matthew Heinen (MN)
Derick Pendergrass (NC)
Paul Vitous (WA)

    The drivers were included in docket numbers FMCSA-2015-0320 and
FMCSA-2017-0254. Their exemptions are applicable as of March 22, 2020,
and will expire on March 22, 2022.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the four exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be

valid for 2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-07116 Filed 4-3-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: February 25, 2009 (Volume 74, Number 36)]
[Notices]
[Page 8547-8549]
[DOCID:fr25fe09-63]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0075]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer, Importer, User
Facility, and Distributor Reporting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 medical device reporting
(MDR); manufacturer, importer, user facility, and distributor
reporting.

DATES:  Submit written or electronic comments on the collection of
information by April 27, 2009.

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:  Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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.

Medical Device Reporting: Manufacturer, Importer, User Facility, and
Distributor Reporting--21 CFR Part 803 (OMB Control Number 0910-0437)--
Extension

    Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to
report ``whenever the manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices: (A) May have caused or contributed to a death or
serious injury, or (B) has malfunctioned and that such device or a
similar device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the malfunction
were to recur * * *.''
    Section 519(b)(1)(A) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the death of a patient of the facility, the facility shall, as soon
as practicable but not later than 10 working days after becoming aware
of the information, report the information to the Secretary and, if the
identity of the manufacturer is known, to the manufacturer of the
device.''
    Section 519(b)(1)(B) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of: (i) Information that
reasonably suggests that a device has or may have caused or contributed
to the serious illness of, or serious injury to, a patient of the
facility * * *, shall, as soon as practicable but not later than 10
working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary if
the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems.
Information from these reports will be used to evaluate risks
associated with medical devices which will enable FDA to take
appropriate regulatory measures in protection of the public health
under section 519 of the act. Thus FDA is requesting approval for these
information collection requirements which are being implemented under
part 803 (21 CFR part 803).
    Respondents to this collection of information are businesses or
other for-profit and nonprofit organizations including user facilities,
manufacturers, and importers of medical devices.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
           21 CFR Section               FDA Form No.       Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19                               .................                 57                     4                228                3.0                684
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.30 and .32                       .................                393                     2                777                1.0                777
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.33                                            3419                393                     1                393                  1                393
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.40 and .42                       .................                 73                    37              2,682                1.0              2,682
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.50 and .52                       .................              1,601                   104            166,271                1.0            166,271
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.56                               .................              1,200                    63             76,186                1.0             76,186
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                .................  .................  ....................            246,537  .................            246,993
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

                                                     Table 2.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17                                                                220                     1                220                 10              2,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.18 (a) through (d)                                             30,000                     1             30,000                1.5             45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                47,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    Part 803 requires user facilities to report to the device
manufacturer and to FDA in case of a death, incidents where a medical
device caused or contributed to a death or serious injury.
Additionally, user facilities are required to annually submit the
number and summary of advents reported during the calendar year, using
FDA Form 3419. Manufacturers of medical devices are required to report
to FDA when they become aware of information indicating that one of
their devices may have caused or contributed to death or serious injury
or has malfunctioned in such a way that should the malfunction recur it
would be likely to cause or contribute to a death or serious injury.
Device importers report deaths and serious injuries to the
manufacturers and FDA. Importers report malfunctions only to the
manufacturers, unless they are unknown, then the reports are sent to
FDA.
    The number of respondents for each CFR section in table 1 of this
document is based upon the number of respondents entered into FDA's
internal databases. FDA estimates, based on its experience and
interaction with the medical device community, that all reporting CFR
sections are expected to take 1 hour to complete, with the exception of
Sec.  803.19. Section 803.19 is expected to take approximately 3 hours
to complete, but is only required for reporting the summarized data
quarterly to FDA. By summarizing events, the total time used to report
for this section is reduced because the respondents do not submit a
full report for each event they report in a quarterly summary report.
    The agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the MDR requirements as
part of their internal quality control system. There are an estimated
30,000 medical device distributors. Although they do not submit MDR
reports, they must maintain records of complaints, under Sec.
803.18(d).
    The agency has estimated that on average 220 user facilities,
importers, and manufacturers would annually be required to establish
new procedures, or revise existing procedures, in order to comply with
this provision.
    Therefore, FDA estimates the one-time burden to respondents for
establishing or revising procedures under Sec.  803.17 to be 2,200
hours (220 respondents x 10 hours). For those entities, a one-time
burden of 10 hours is estimated for establishing written MDR
procedures. The remaining manufacturers, user facilities, and
importers, not required to revise their written procedures to comply
with this provision, are excluded from the burden because the
recordkeeping activities needed to comply with this provision are
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
    Under Sec.  803.18, 30,000 respondents represent distributors,
importers, and other respondents to this information collection. FDA
estimates that it should take them approximately 1.5 hours to complete
the recordkeeping requirement for this section. Total hours for this
section equal 45,000 hours.

    Dated: February 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4057 Filed 2-24-09; 8:45 am]

BILLING CODE 4160-01-S