[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Notices]
[Pages 31185-31186]
[FR Doc No: 2020-11067]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2020-0020; FRL-10009-37-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Confidentiality Rules (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Confidentiality Rules (EPA ICR
Number 1665.14, OMB Control Number 2020-0003) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through May 31, 2020. Public comments were
previously requested via the Federal Register on January 23, 2020
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before June 22, 2020.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OGC-2020-0020, to (1) EPA online using www.regulations.gov (our
preferred method) or<EMAIL_ADDRESS>EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI), or other information whose disclosure is restricted
by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Christopher T. Creech, National FOIA
Office, Office of General Counsel, Environmental Protection Agency;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov. The telephone number for the Docket Center is 202-
566-1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: The U.S. Environmental Protection Agency (EPA or Agency)
established the requirements set forth in 40 CFR 2.201 et seq.
``Confidentiality of Business Information'' to establish rules to
govern claims of confidential business information (CBI), i.e., the
rules governing the handling by the Agency of business information
which is or may be entitled to confidential treatment, determining
whether such information is entitled to confidential treatment for
reasons of business confidentiality and responding to Freedom of
Information Act (FOIA) requests pursuant to 5 U.S.C. 552 for this
information.
    Form Numbers: None.
    Respondents/affected entities: Respondents can potentially include
any business that submitted to EPA information that may be claimed as
CBI. Respondents can be entities in both the manufacturing (SIC codes
20-30) and non-manufacturing sectors (no SIC codes identified).
    Respondent's obligation to respond: Voluntary and mandatory.
    Estimated number of respondents: 198 (total).
    Frequency of response: 1 response per respondent annually.
    Total estimated burden: 752.4 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $169,290.00 (per year), includes $0
annualized capital or operation & maintenance costs.
    Changes in the Estimates: The revised requests for substantiation
will decrease the estimated burden hours for each response, although it
increases the total estimated respondent burden compared with the ICR
currently approved by OMB. The decrease is 2 hours for each business
response; the increase is based on an expected higher response rate
under the new form, producing an increase from 488 hours to 752 hours
total. This decrease of hours spent are due to the removal of a
question that required a company to describe, with specificity, the
``substantial competitive harm'' that would occur as a direct result of
disclosing the information.
    EPA modified its substantiation questions because of the U.S.
Supreme Court's decision in Food Marketing Institute v. Argus Leader
Media (Argus), 139 S. Ct. 2356 (2019), which evaluated the definition
of ``confidential'' as used in Exemption 4 of the FOIA. 5 U.S.C.
552(b)(4). In the Argus decision, the Court held that at least where
``[1] commercial or financial information is both customarily and
actually treated as private by its owner and [2] provided to the
government under an assurance of privacy, the information is
'confidential' within the meaning of Exemption 4.'' Argus, 139 S. Ct.
at 2366. EPA has reduced burdens to business submitters by removing the
requirement to explain with specificity whatever ``substantial
competitive harm'' a submitter claims would ensue from release of each
CBI claim. The evaluation of ``substantial competitive harm'' had
required businesses to analyze and describe the potential impacts of
release. EPA has replaced that question with modified questions that
require a factual description of the submitter's handling and treatment
of the CBI-claimed information, as well as a description of any
assurances provided by EPA at the time of submission. This replacement
will reduce the burden on companies since evaluation and analysis of
``substantial competitive harm'' is no longer required. Further, EPA
reframed preexisting questions to solicit ``yes'' or ``no'' responses,
which further reduces burdens on submitters. These modifications will
result in greater clarity to business submitters and improved responses
as the Agency completes its confidentiality determinations.
    The Agency anticipates that this lower burden on each response will
increase the response rate from 21% in the prior analysis to 66% in the
present analysis. EPA has already experienced an increase in response
rate because of the Supreme Court's decision and expects this change to
continue under the new form. EPA also made other adjustments in its
analysis including adjustments in the hourly costs for both the Agency
and responding companies as well as removing a category of burden that
was not relevant to EPA's information request.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-11067 Filed 5-21-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67024-67025]
[FR Doc No: 2013-26718]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0576; Airspace Docket No. 13-ANM-11]

Modification of Class E Airspace; Prineville, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class E airspace at Prineville, OR, to
accommodate Area Navigation (RNAV) Global Positioning System (GPS)
standard instrument approach procedures at Prineville Airport. This
improves the safety and management of Instrument Flight Rules (IFR)
operations at the airport. This action also adjusts the geographic
coordinates of the airport.

DATES: Effective date, 0901 UTC, February 6, 2014. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation

Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW, Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 26, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to modify controlled airspace at
Prineville, OR (78 FR 52717). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Except for
editorial changes this rule is the same as published in the NPRM.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9X dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying Class E airspace extending upward from 700 feet
above the surface, expanding the segments west and southeast of
Prineville Airport, Prineville, OR, to accommodate RNAV (GPS) standard
instrument approach procedures at the airport. This action is necessary
for the safety and management of IFR operations. The geographic
coordinates of the airport are adjusted in accordance with the FAA's
aeronautical database.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act. The FAA's authority to issue rules
regarding aviation safety is found in Title 49 of the U.S. Code.
Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it modifies
controlled airspace at Prineville Airport, Prineville, OR.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9X, Airspace Designations and
Reporting Points, dated August 7, 2013, and effective September 15,
2013 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM OR E5 Prineville, OR [Modified]

Prineville Airport, OR
    (Lat. 44[deg]17'16'' N., long. 120[deg]54'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of the airport, and 5 miles each side of
the 281[deg] bearing of the airport to 12.4 miles west, and 3.5
miles each side of the 120[deg] bearing of the airport to 7.7 miles
southeast; that airspace extending upward from 1,200 feet above the
surface within a 9.2-mile radius of the airport clockwise from the
320[deg] bearing to the 190[deg] bearing of the airport, thence
within a 27.4-mile radius of the airport clockwise from the 190[deg]
bearing to the 230[deg] bearing of the airport, thence within a
37.5-mile radius of the airport clockwise from the 230[deg] bearing
to the 320[deg] bearing of the airport, thence 6.8 miles each side
of the 121[deg] bearing of the airport to 34.3 miles southeast.

    Issued in Seattle, Washington, on October 30, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-26718 Filed 11-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24868-24871]
[FR Doc No: 2021-09809]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-N-0387]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recommended Content of Medical Product Communications
That Are Consistent With the Food and Drug Administration-Required
Labeling and Recommendations for Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar Entities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
recommended content of medical product communications that are
consistent with the FDA-required labeling and recommendations for drug
and device manufacturer communications with payors, formulary
committees, and similar entities.

DATES: Submit either electronic or written comments on the collection
of information by July 9, 2021.

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 July 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 9, 2021. 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-2021-N-0387 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recommended Content of Medical
Product Communications That Are Consistent With the FDA-Required
Labeling and Recommendations for Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar
Entities.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

I. Medical Product Communications That Are Consistent With the FDA-
Required Labeling--Questions and Answers

OMB Control Number 0910-0856--Extension

    This information collection supports the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and FDA's implementing regulations that govern
drug and device labeling and prescription drug and restricted device
advertising. The FD&C Act specifies that a drug or device shall be
deemed to be misbranded if its labeling is false or misleading in any
particular (section 502(a) (21 U.S.C. 352(a)) and that labeling may be
considered misleading if it fails to reveal material facts about the
product being promoted, including facts that are material in light of
the representations made in a promotional piece (section 201(n) (21
U.S.C. 321(n))). Similarly, under sections 201(n) and 502(n) of the
FD&C Act and FDA's implementing regulations (21 CFR 202.1(e)(5)(i) and
(iii)), an advertisement for a prescription drug must not be false or
misleading with respect to side effects, contraindications, or
effectiveness, or fail to reveal material facts about the product being
advertised, including facts that are material in light of the
representations made in a promotional piece. The FD&C Act also
specifies that restricted device advertisements must not be false or
misleading (section 502(q)(1)) and must reveal facts that are material
about the product being advertised (section 201(n)).
    To assist respondents with the requirements drug and device
labeling and prescription drug and restricted device advertising, we
developed the guidance for industry entitled ``Medical Product
Communications That Are Consistent With the FDA-Required Labeling--
Questions and Answers'' (June 2018) (medical product communications
guidance), available at https://www.fda.gov/media/133619/download. This
medical product communications guidance includes recommendations that
firms consider when developing ``consistent with the FDA-required
labeling (CFL)'' presentations in their labeling and advertising
materials to help ensure the presentations are not false or misleading
in violation of the FD&C Act and FDA's implementing regulations. The
guidance also describes FDA's thinking when examining the consistency
of a firm's product communications with that product's own FDA-required
labeling.
    As explained in the guidance, if a firm communicates information
that is not contained in its product's FDA-required labeling but that
is determined to be consistent with the FDA-required labeling, FDA does
not intend to rely on that communication to establish a new intended
use that is different from the use or uses for which the product is
legally marketed. Establishing a product's intended uses is an element
in establishing certain violations under the FD&C Act and Public Health
Service Act. Firms' communications about their products that are
consistent with the products' FDA-required labeling but that are false
or misleading may subject a firm to enforcement action under the FD&C
Act. Thus, the guidance not only describes FDA's thinking on
communications that are consistent with the FDA-required labeling, but
also provides general recommendations intended to help firms comply
with requirements in the FD&C Act and FDA's implementing regulations
for conveying information that is consistent with the FDA-required
labeling in a truthful and non-misleading way. The medical product
communications guidance recommends that firms accurately represent in
the communications any study results or other data and information that
are relied upon to support a firm's CFL promotional communication.
Other

recommendations include the clear and prominent disclosure of aspects
of study design and methodology that are material for audiences to
accurately interpret the information being presented (e.g., type of
study, study objectives, product dosage and use regimens, control or
controls used, patient population studied), as well as material
limitations related to the study design, methodology, and results.
Also, the guidance recommends that firms accurately characterize and
contextualize the relevant information about the product, including by
disclosing unfavorable or inconsistent findings. In addition, the
guidance recommends that firms disclose material contextual information
from the FDA-required labeling in these communications, such as data
and information from studies in the FDA-required labeling that are
relevant to the data or information presented in the CFL promotional
communication.
    The recommendations will help ensure that health care professional
and consumer audiences receive truthful information about the benefits
and risks of drugs and devices in firms' CFL promotional communications
and that material contextual information is included in these
communications so that audiences are not misled. Accurate information
helps these audiences know whether drugs or devices may be appropriate
for them or their patients and know what they can expect to experience
when prescribing or using these products.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                  Information collection activity                       Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324               30            9,720                4           38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since our last request for OMB approval, we have made no
adjustments to the currently approved burden estimate.

II. Recommendations for Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities

OMB Control Number 0910-0857--Extension

    This information collection also supports implementation of section
502(a) of the FD&C Act and applicable Agency regulations. Section
502(a)(1) of the FD&C Act provides that a drug or device is deemed to
be misbranded ``[i]f its labeling is false or misleading in any
particular.'' Under longstanding FDA practice and FDA's statute and
regulations, and under case law, labeling encompasses more than merely
the label of the drug, but extends to other written, printed, or
graphic matter ``accompanying such article'' (section 201(m) of the
FD&C Act; see also 21 CFR 1.3(a)). Section 502(a) also includes a
provision about communication of health care economic information
(HCEI) to payors through labeling or advertising. To assist respondents
in this regard, we developed the guidance for industry and review staff
entitled ``Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities--Questions and Answers''
(June 2018) (drug and device communications guidance), available at
https://www.fda.gov/media/133620/download.
    This drug and device communications guidance includes
recommendations regarding information firms should include in HCEI for
prescription drugs if they choose to disseminate such materials (HCEI
materials) to payors, in accordance with section 502(a) of the FD&C
Act. Specifically, if a manufacturer communicates HCEI for approved
prescription drugs (including biological products that also meet the
definition of drug under the FD&C Act and approved or cleared medical
devices (collectively referred to as medical products)) to payors, FDA
recommends that firms include in HCEI materials disseminated to payors
information about: (1) Various aspects of study design and methodology
of an economic analysis (i.e., type of analysis, modeling technique,
patient population, perspective or viewpoint, treatment comparator,
time horizon, outcome measures, cost estimates, and assumptions); (2)
factors that limit generalizability of an economic analysis;
limitations to an economic analysis; and (3) sensitivity analyses, if
applicable, to allow for informed decision making by payors.
    Furthermore, FDA recommends that firms include other information
when disseminating HCEI materials, as applicable, to provide a balanced
and complete presentation. Such information includes a statement of the
FDA-approved indication of the drug and a copy of the most current FDA-
approved labeling. Under section 502(a) of the FD&C Act, firms must
also include a conspicuous and prominent statement to describe any
material differences between the HCEI and the FDA-approved labeling.
HCEI materials should also disclose whether certain studies or data
sources were omitted from an economic analysis and how the omission of
those studies or data sources may alter the conclusions presented in
the analysis. Moreover, FDA recommends that HCEI materials disclose
important risk information associated with the approved use of the
drug, and pursuant to section 502(a) of the FD&C Act, HCEI materials
must disclose any additional risk information related to assumptions
that vary from the approved labeling. In addition, HCEI materials
should disclose potential financial or affiliation biases to the extent
reasonably known by firms at the time of dissemination.
    The drug and device communications guidance provides similar
recommendations for HCEI materials disseminated to payors about
approved or cleared devices.
    If firms choose to make communications to payors about unapproved
products or unapproved uses of approved or cleared products, FDA
recommends that firms include a clear statement with their
communications that the product or use is not approved or cleared and
that the safety or effectiveness of the product or use has not been
established.
    We estimate the burden of this collection of information as
follows:

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Recommended information to be                430          10.465           4,500              20          90,000
 included when firms choose to
 disseminate HCEI materials to
 payors about approved
 prescription drugs.............
Recommended information to be                236              10           2,360              20          47,200
 included when firms choose to
 disseminate HCEI materials to
 payors about approved or
 cleared devices................
Recommended information to be                717               2           1,434             0.5             717
 included when firms choose to                                                      (30 minutes)
 disseminate information about
 unapproved products or
 unapproved uses of approved or
 cleared products...............
Follow-up information to payors              359               2             718               2           1,436
 regarding previously
 communicated information about
 unapproved products or
 unapproved uses of approved or
 cleared products...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           9,012  ..............         139,353
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have adjusted the estimate of burden we associate with the
information collection recommendations in the guidance to reflect an
increase of 2,000 hours and 100 responses annually.

    Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09809 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: October 31, 2001 SUBJECT: Pentachloronitrobenzene ( PCNB). ( List A, Case No. 0128) The Outcome of the HED Metabolism Assessment Review Committee Held on 10/ 04/ 01 to discuss PCNB technical materials from Uniroyal and Amvac ( 10/ 4/ 01). Chemical 056502.

FROM: Sheila Piper, Chemist Diana Locke, Toxicologist Health Effects Division ( 7509C)

THROUGH: Francis B. Suhre, Branch Senior Scientist Chemistry and Exposure Branch Health Effects Division ( 7509C) and Christine Olinger, Chair of HED MARC Reregistration Branch I Health Effects Division ( 7509C)

TO: Yan W. Donovan, Chemist, RAB1/ HED ( 7509C) MARC Executive Secretary Material Reviewed The Metabolism Assessment Review Committee ( MARC) met on October 4, 2001 to determine if the variability in the level of active ingredient of PCNB and its contaminants in the Uniroyal and Amvac test materials used for toxicity studies is significant enough to call into question current registrations for the Uniroyal and Amvac's PCNB technical grade of active ingredients. The Committee also discussed the concern that some of the contaminants or combinations of contaminants found in the Uniroyal and Amvac's PCNB TGAIs that may be of toxicological concern and would trigger additional risk assessments and/ or data requirements. Page  2 The MARC conducted a side by side comparison of the Uniroyal and Amvac submitted toxicity data with data on the impurities by using the following approach. The registrants had submitted batch numbers and formulation information, including the trace amount ( relative weight basis) of manufacturing impurities that are of toxicological concern. A literature search was conducted for toxicity data on the impurities and therefore, the MARC had some information about the toxic effects induced by the impurities and the levels ( LOAELs) at which these effects were seen. With the submitted batch information, the MARC was able to calculate the amount of each impurity that was administered in the toxicity studies, along with the PCNB. Both the toxic effects and the effective doses of the impurities were compared with the effects observed in the PCNB studies and the administered doses of the impurities. It should be noted that in 1994, the Agency informed Uniroyal and Amvac of the need to reduce the relative amount of HCB in their technical formulations to 0.05 % and the amount of pentachlorobenzene ( PCB) to 0.01 % ( Letter. Jack Housenger. October 4, 1994).

The formulations of the materials used for the toxicity tests, Amvac's and Uniroyal's, contain more than 0.01 % HCB ( most were greater than the 0.05%). It would stand to reason then, that by using the submitted toxicity data for endpoint selection, the Agency would be conservative in its health protective approach and would not be underestimating the potential risks. In addition, in a written communication from the Agency's Office of General Counsel ( OGC), the Health Effects Division ( HED) was informed that HED science reviewers may review studies submitted by one registrant in connection with an EPA registration/ reregistration action for another registrant [ Communication. Mark Dyner ( OGC) to Beth Doyle ( HED). November 1, 2000]. It went on to say that EPA scientists can and should look at all relevant data in the Agency's files when making decisions.

MARC Conclusions The MARC can find no evidence that the chemical composition ( i. e. impurity levels) differences among the formulations tested in the toxicity studies affected the NOAELS/ LOAELS and endpoints found. Other factors likely were greater contributors to the differences in the side by side toxicity studies submitted by the two registrants. Furthermore, it is the MARC's opinion that the contaminants at the level found in the tested batches and the Page  3 Cl Cl Cl Cl Cl NO 2 Cl Cl Cl Cl Cl Cl levels mandated by the Agency in the 12/ 94 letter will not bias the results of the toxicity studies.

Individuals in Attendance 1. MARC Members Alberto Protzel, Christine Olinger, Rick Loranger, Leung Cheng, John Doherty, Yan Donovan, Abdallah Khasawinah, David Nixon, Thuy Ngnyen and Sheila Piper.

2. Scientists ( non MARC members)

Francis Suhre( CEB), Mike Ioannou( TOX1), Lucy Shanaman( EFED), Ken Dockter ( RRB1) and Diana Locke ( RRB1).

cc: SF, RF, List B File, S. Piper, D. Locke ( RRB1) RDI: C. Olinger: 10/ 17/ 01; F. B. Suhre: 10/ 18/ 01 7509C: CEB1: CM 2: Room 810F: 308 2717: PCNB Table 1: Structures of PCNB and metabolites Chemical Name/ Structure Pentachloronitrobenzene ( PCNB) Hexachlorobenzene ( HCB) Page  4 Cl Cl Cl Cl Cl C H 3 N H O CH 3 NO 2 Cl 4 Cl Cl Cl Cl Cl NH 2 Pentachlorobenzene ( PCB) N, N dimethylformamide Tetrachoronitrobenzene ( TCNB) Pentachloroaniline ( PCA)


[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35103-35104]
[FR Doc No: 2012-14283]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2012-15]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. 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 involved and must be received on or before July 2, 2012.

ADDRESSES: You may send comments identified by Docket Number FAA-2012-
0437 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility,
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility 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.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility 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: Tyneka Thomas ARM-105,<PHONE_NUMBER>,
FAA, Office of Rulemaking, 800 Independence Ave SW., Washington, DC
20591. This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 31, 2012.
Lirio Liu,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2012-0437.
    Petitioner: Billy G. Witt.
    Section of 14 CFR Affected: 14 CFR 61.23(a)(3)(vi) and 61.39(a)(4).
    Description of Relief Sought: The relief sought would allow Billy
G. Witt eligibility to take a private pilot practical test without
holding an FAA third-class medical certificate.

[FR Doc. 2012-14283 Filed 6-11-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Notices]
[Page 45112]
[DOCID:fr02au10-54]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0560; FRL-9184-4]

Call for Information: Information on Greenhouse Gas Emissions
Associated With Bioenergy and Other Biogenic Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Call for Information; correction.

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SUMMARY: The Environmental Protection Agency published in the Federal
Register on July 15, 2010 a Call for Information to solicit information
and viewpoints from interested parties on approaches to accounting for
greenhouse gas emissions from bioenergy and other biogenic sources.
Inadvertently, incorrect text was published for one of the items on
which EPA seeks comment in Section I.D. This document corrects both
that text and a typographical error in a separate reference to the
Clean Air Act in Section I.D.

FOR FURTHER INFORMATION CONTACT: Jennifer Jenkins, Climate Change
Division, Office of Atmospheric Programs (MC-6207J), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Corrections

    EPA published a Call for Information in the Federal Register (75 FR
41173) on July 15, 2010. In the published document, the text of the
first bulleted item in Section I.D (beginning on page 41175, third
column) was incorrect. The correct text for that item is as follows:

     Biomass under PSD/BACT. What criteria might be used to
consider biomass fuels and the emissions resulting from their
combustion differently with regard to applicability under PSD and
with regard to the Best Available Control Technology (BACT) review
process under PSD?

    In addition, the first full sentence of the third bulleted item in
Section I.D (first column, page 41176) contained a typographical error.
The correct text for that sentence is: ``The Clean Air Act (CAA)
provisions typically apply at the unit, process, or facility scale,
whereas the IPCC Guidance on accounting for GHG emissions from
bioenergy sources was written to be applicable at the national scale.''

    Dated: July 27, 2010.
Brian McLean,
Director, Office of Atmospheric Programs.
[FR Doc. 2010-19031 Filed 7-30-10; 8:45 am]
BILLING CODE 6560-50-P