[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Page 30481]
[FR Doc No: 2015-12918]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4213-DR; Docket ID FEMA-2015-0002]

Connecticut; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Connecticut (FEMA-4213-DR), dated April 8, 2015, and
related determinations.

DATES: Effective date: May 8, 2015.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Connecticut is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 8, 2015.

    New Haven County for Public Assistance.
    New Haven County for snow assistance under the Public Assistance
program for any continuous 48-hour period during or proximate the
incident period.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-12918 Filed 5-27-15; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Page 12476]
[FR Doc No: 2022-04584]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4513-DR; Docket ID FEMA-2022-0001]

Virgin Islands; Amendment No. 10 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the territory of the U.S. Virgin Islands (FEMA-4513-DR), dated
April 2, 2020, and related determinations.

DATES: This change occurred on February 16, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, David
Warrington, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Chad M. Gorman as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-04584 Filed 3-3-22; 8:45 am]
BILLING CODE 9111-23-P


part 1904 records for its establishment(s)? Yes, if your enterprise or
corporate office had ownership of or control over one or more
establishments required to submit information under paragraph (a)(1) or
(2) of this section, then the enterprise or corporate office may
collect and electronically submit the information for the
establishment(s).
    (c) Reporting dates. (1) In 2017 and 2018, establishments required
to submit under paragraph (a)(1) or (2) of this section must submit the
required information according to the table in this paragraph (c)(1):

------------------------------------------------------------------------
                    Establishments
                   submitting under   Establishments
                   paragraph (a)(1)  submitting under
                    of this section  paragraph (a)(2)
 Submission year    must submit the   of this section      Submission
                       required       must submit the       deadline
                   information from      required
                    this form/these  information from
                        forms:          this form:
------------------------------------------------------------------------
2017.............  300A............  300A............  July 1, 2017.
2018.............  300A, 300, 301..  300A............  July 1, 2018.
------------------------------------------------------------------------

    (2) Beginning in 2019, establishments that are required to submit
under paragraph (a)(1) or (2) of this section will have to submit all
of the required information by March 2 of the year after the calendar
year covered by the form or forms (for example, by March 2, 2019, for
the forms covering 2018).

0
6. Add appendix A to subpart E of part 1904 to read as follows:

Appendix A to Subpart E of Part 1904--Designated Industries for Sec.
1904.41(a)(2) Annual Electronic Submission of OSHA Form 300A Summary of
Work-Related Injuries and Illnesses by Establishments With 20 or More
Employees but Fewer Than 250 Employees in Designated Industries

----------------------------------------------------------------------------------------------------------------
                        NAICS                                                  Industry
----------------------------------------------------------------------------------------------------------------
11..................................................  Agriculture, forestry, fishing and hunting.
22..................................................  Utilities.
23..................................................  Construction.
31-33...............................................  Manufacturing.
42..................................................  Wholesale trade.
4413................................................  Automotive parts, accessories, and tire stores.
4421................................................  Furniture stores.
4422................................................  Home furnishings stores.
4441................................................  Building material and supplies dealers.
4442................................................  Lawn and garden equipment and supplies stores.
4451................................................  Grocery stores.
4452................................................  Specialty food stores.
4521................................................  Department stores.
4529................................................  Other general merchandise stores.
4533................................................  Used merchandise stores.
4542................................................  Vending machine operators.
4543................................................  Direct selling establishments.
4811................................................  Scheduled air transportation.
4841................................................  General freight trucking.
4842................................................  Specialized freight trucking.
4851................................................  Urban transit systems.
4852................................................  Interurban and rural bus transportation.
4853................................................  Taxi and limousine service.
4854................................................  School and employee bus transportation.
4855................................................  Charter bus industry.
4859................................................  Other transit and ground passenger transportation.
4871................................................  Scenic and sightseeing transportation, land.
4881................................................  Support activities for air transportation.
4882................................................  Support activities for rail transportation.
4883................................................  Support activities for water transportation.
4884................................................  Support activities for road transportation.
4889................................................  Other support activities for transportation.
4911................................................  Postal service.
4921................................................  Couriers and express delivery services.
4922................................................  Local messengers and local delivery.
4931................................................  Warehousing and storage.
5152................................................  Cable and other subscription programming.
5311................................................  Lessors of real estate.
5321................................................  Automotive equipment rental and leasing.
5322................................................  Consumer goods rental.
5323................................................  General rental centers.
5617................................................  Services to buildings and dwellings.
5621................................................  Waste collection.
5622................................................  Waste treatment and disposal.
5629................................................  Remediation and other waste management services.
6219................................................  Other ambulatory health care services.

6221................................................  General medical and surgical hospitals.
6222................................................  Psychiatric and substance abuse hospitals.
6223................................................  Specialty (except psychiatric and substance abuse)
                                                       hospitals.
6231................................................  Nursing care facilities.
6232................................................  Residential mental retardation, mental health and
                                                       substance abuse facilities.
6233................................................  Community care facilities for the elderly.
6239................................................  Other residential care facilities.
6242................................................  Community food and housing, and emergency and other relief
                                                       services.
6243................................................  Vocational rehabilitation services.
7111................................................  Performing arts companies.
7112................................................  Spectator sports.
7121................................................  Museums, historical sites, and similar institutions.
7131................................................  Amusement parks and arcades.
7132................................................  Gambling industries.
7211................................................  Traveler accommodation.
7212................................................  RV (recreational vehicle) parks and recreational camps.
7213................................................  Rooming and boarding houses.
7223................................................  Special food services.
8113................................................  Commercial and industrial machinery and equipment (except
                                                       automotive and electronic) repair and maintenance.
8123................................................  Dry-cleaning and laundry services.
----------------------------------------------------------------------------------------------------------------

PART 1902--STATE PLANS FOR THE DEVELOPMENT AND ENFORCEMENT OF STATE
STANDARDS

0
7. The authority citation for part 1902 is revised to read as follows:

    Authority: Sec. 18, 84 Stat. 1608 (29 U.S.C. 667); Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

0
8. In Sec.  1902.7, revise paragraph (d) to read as follows:

Sec.  1902.7  Injury and illness recording and reporting requirements.

* * * * *
    (d) As provided in section 18(c)(7) of the Act, State Plan States
must adopt requirements identical to those in 29 CFR 1904.41 in their
recordkeeping and reporting regulations as enforceable State
requirements. The data collected by OSHA as authorized by Sec.  1904.41
will be made available to the State Plan States. Nothing in any State
plan shall affect the duties of employers to comply with Sec.  1904.41.

[FR Doc. 2016-10443 Filed 5-11-16; 8:45 am]
 BILLING CODE 4510-26-P


Page 1 of 2 Memorandum From: Carey A. Johnston, P. E. USEPA/ OW/ OST ph: ( 202) 566 1014 johnston. carey@ epa. gov To: Public Record for the Effluent Guidelines Program Plan for 2004/ 2005 DCN 01092, Section 3.01 EPA Docket Number OW 2003 0074 ( www. epa. gov/ edockets/)

Date: August 11, 2004 Re: Alaska Coalbed Methane Information The following webpages provide information on Alaska shallow gas ( including CBM operations). Additionally, attached to this memo are two briefings presented at a September 20, 2002, USGS meeting held in the Rayburn office building. The meeting was sponsored by the House Coalbed Methane Caucus ( chaired by Tom Davis, VA, and Billy Tauzin, LA), however neither attended the meeting. The meeting was chaired by Rebecca W. Watson, DOI Assistant Secretary for Land and Minerals Management and there were three speakers: ( 1) P. Patrick Leahy, USGS, Associate Director for Geology; ( 2) Asghar Shariff, BLM, Chief of Reservoir Management Group; ( 3) Richard Glen, Arctic Slope Regional Corporation.

Alaska Coal Resources and Coalbed Methane Potential http:// pubs. usgs. gov/ bul/ b2198/ " A potential untapped resource in Alaska is coalbed methane ( CBM). With more than 5,500 billion short tons ( 4,990 billion metric tons) of combined coal resources of Alaska coal, the in place gas resource could be exceedingly large. Smith ( 1995) estimated a total of 1,000 trillion cubic feet ( 28 trillion cubic meters) of in place CBM resource. A large part of the gas resource may be contained in subbituminous coal. A large part of the coal resources, about 5,470 billion short tons ( 4,962 billion metric tons), is found in the Northern Alaska North Slope and Southern Alaska Cook Inlet coal provinces where in place and planned infrastructure ( pipelines, highways, and so forth) may potentially assist in the transportation and marketability of coalbed gas."

Alaska Coalbed Methane Workshop http:// www. westcoastpttc. org/ workshops/ 99 00/ 030300. htm Coalbed methane stirs pot in Alaska http:// www. casperstartribune. net/ articles/ 2003/ 12/ 27/ news/ wyoming/ 43a16f754cabd95887256e0 900018592. txt " Unlike Wyoming, Alaska has yet to see more than a couple dozen coalbed methane test wells. Page 2 of 2 But with vast amounts of shallow coals and increasing national interest to develop the low cost, clean burning fuel, many people in Alaska anticipate a boom similar to what has already hit southern Colorado and northeastern Wyoming."

Alaska Center for the Environment http:// www. akcenter. org/ coalbed. html " Almost 230,000 acres have already been approved for CBM development in Southcentral Alaska, most in the Mat Su Valley. Lease applications are pending for up to another 68,000 acres of Valley land."

State of Alaska, Department of Natural Resources, Division of Geological & Geophysical Surveys http:// wwwdggs. dnr. state. ak. us/ download/ 0211news. pdf Potential energy resources include coalbed gas, shalebed methane, conventional gas, and oil.

State of Alaska, Department of Natural Resources, Division of Oil and Gas http:// www. dog. dnr. state. ak. us/ oil/ products/ publications/ otherreports/ o& g_ programs/ shallow_ ga s. pdf Alaska's newest leasing program allows the Division of Oil and Gas to issue non competitive leases to explore for and develop natural gas reservoirs ( including coalbed methane) located within 3,000 feet of the surface. The intent of this program is to locate local sources of gas, which can be delivered to consumers in remote areas of the state at lesscost than alternative energy sources.


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29213-29216]
[FR Doc No: 2019-13128]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2313]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Study of Oncology Indications in Direct-to-Consumer
Television Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 ``Study of Oncology Indications
in Direct-to-Consumer Television Advertising.'' This research consists
of two studies examining the presentation of oncology indications in
direct-to-consumer (DTC) television ads.

DATES: Submit either electronic or written comments on the collection
of information by August 20, 2019.

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 August 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 20, 2019. 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-2019-N-2313 for ``Study of Oncology Indications in Direct-to-
Consumer Television Advertising.'' 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For copies of the questionnaire contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the

public submit reports, keep records, or provide information to a third
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information 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.

Study of Oncology Indications in Direct-to-Consumer Television
Advertising

(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.
    OPDP's mission is to protect the public health by helping to ensure
that prescription drug information is truthful, balanced, and
accurately communicated, so that patients and healthcare providers can
make informed decisions about treatment options. 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 we
believe are most central to our mission, focusing 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 falls under the topic of advertising features (content and
format).
    Oncology products are increasingly being promoted to consumers via
DTC television advertising. Oncology indications are often complicated
and supported by different clinical endpoints such as overall survival,
overall response rate, and progression-free survival (Ref. 1) that are
referenced in the DTC TV ads. The first objective of this project is to
determine whether disclosing information about the nature of the
endpoints that support the indications for oncology products helps
consumers understand the drug's efficacy. This objective complements
OPDP's research examining disclosing information about FDA's
accelerated approval pathway to consumers (May 8, 2019, 84 FR 20148)
and OPDP's research on disclosing oncology information to healthcare
professionals (OMB control number 0910-0864--Disclosures of Descriptive
Presentations in Professional Oncology Prescription Drug Promotion).
Although these studies all contribute to our knowledge of the
communication of cancer treatment information, the current study
specifically examines particular endpoints that are well-known to the
professional oncology community and are now used in DTC advertising.
    Because of the length of some indications, sponsors sometimes
convey some of the indication in superimposed text rather than in the
audio in the TV ads. The second objective is to test whether consumers
adequately comprehend indication statements when portions of the
indication are presented only in the superimposed text of television
ads while other information is conveyed in the audio. This objective
extends OPDP's previous research on the use of dual-modality risk
presentations (presenting the information in two modes at the same
time; OMB control numbers 0910-0634--Experimental Evaluation of the
Impact of Distraction, 0910-0652--Experimental Study: Toll-Free Number
for Consumer Reporting of Drug Product Side Effects in Direct-to-
Consumer Television Advertisements for Prescription Drugs, and 0910-
0772--Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing) to the context of indication statements. This
previous research supports the use of dual modality to increase
consumers' understanding of risk information (January 27, 2012, 77 FR
4273) (Refs. 2 and 3).
    We plan to conduct two rounds (one for each objective) of nine 1-
hour in-person cognitive interviews of adults 18 years of age or older
to refine the questionnaires and stimuli (18 participants total). We
plan to conduct two pretests (one for each objective) not longer than
20 minutes, administered via internet panel, to test the experimental
manipulations and pilot the main study procedures.
    We plan to conduct two main studies (one for each objective) not
longer than 20 minutes, administered via internet panel. For Study 1,
we will create two television ads for fictitious oncology prescription
drugs to increase the generalizability of the results (one solid tumor
indication and one hematology indication). The ads will include audio
claims about overall survival, overall response rate with and without a
disclosure, or progression-free survival with and without a disclosure
(see table 1 for the Study 1 design).
    Some current television ads for oncology products include
disclosures that are intended to help consumers differentiate surrogate
endpoints like progression-free survival and overall response rate from
overall survival. Examples include ``At the time of analysis, overall
survival comparison was not yet available'' and ``Clinical trials are
ongoing to determine if there is an overall survival benefit.'' The
disclosure we use in the study will be based on disclosures currently
in use and will be informed by consumer feedback elicited in focus
groups conducted prior to the cognitive testing (approved under OMB
control number 0910-0695). For example, the study disclosure may
include language such as ``We currently do not know if Drug X helps
people live longer.''
    Participants will be randomly assigned to view one prescription
drug television ad and then complete a questionnaire that assesses
whether participants noticed the disclosure, their interpretations of
the disclosure, their retention of the endpoint, and their perceptions
of the drug's benefits and risks. We will also measure covariates such
as demographics, cancer history,

and literacy. Without a disclosure, we hypothesize that participants
will not differentiate between overall survival, overall response rate,
and progression-free survival. We hypothesize that a disclosure will
help participants understand the surrogate endpoints (i.e., overall
response rate and progression-free survival) and thus will lead to
greater understanding of the drug's efficacy compared with conditions
without the disclosure. We will explore unintended effects of the
disclosure, such as whether the disclosure lowers perceived efficacy
compared with the overall survival condition.
    For the second objective, in Study 2 we will vary the presentation
of the products' indication, such that material information related to
the indication will appear in superimposed text only, in the audio
only, in both superimposed text and audio, or in neither (the control
condition; see tables 2 and 3 for the Study 2 design). Participants
will be randomly assigned to view a prescription drug television ad and
then complete a questionnaire that assesses their retention and
comprehension of the information. Following previous research on dual-
modality presentations, we hypothesize that participants who view an ad
with the material information in the audio and text will have greater
retention of that information than participants in any other condition.
We also hypothesize that participants who view an ad with the material
information in the audio only will have greater retention of that
information than participants in the superimposed text condition and
the control condition. To test Study 1 and 2 hypotheses, we will
conduct inferential statistical tests such as logistic regression and
analysis of variance.
    The questionnaires are available upon request from
<EMAIL_ADDRESS>    For all phases of this research, we will recruit a general
population sample of adult volunteers 18 years of age or older. We will
exclude individuals who work for the Department of Health and Human
Services or work in the healthcare, marketing, or pharmaceutical
industries. We will use literacy quotas to ensure that our sample
includes participants with a range of literacy skills. We will also
exclude pretest participants from the main studies, and participants
will not be able to participate in both Studies 1 and 2. With the
sample sizes described below, we will have sufficient power to detect
small-sized effects in Studies 1 and 2 (table 4).

                                                                 Table 1--Study 1 Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Overall     Overall response                        Progression-free
                            Indication                                Overall      response        rate with       Progression- free     survival with
                                                                      survival       rate         disclosure           survival           disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Solid Tumor.......................................................
Hematology........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The solid tumor condition will be non-small cell lung cancer. The hematology condition will be multiple myeloma. Claims and disclosures are TBD,
  based on focus group feedback. Overall survival and progression-free survival claims will be the same for both indications. Study 1 will use the
  control ad from Study 2.

                                      Table 2--Study 2 Design: Solid Tumor
----------------------------------------------------------------------------------------------------------------
                                             Indication presentation
-----------------------------------------------------------------------------------------------------------------
                                                                                Material information
Material information in  superimposed  Material information in  Material information in    not in  superimposed
              text only                       audio only           superimposed text +        text or audio
                                                                         audio                  (control)
----------------------------------------------------------------------------------------------------------------
Audio: Drug X is for adults with       Audio: Drug X is for     Audio: Drug X is for     Audio: Drug X is for
 advanced non-small cell lung cancer.   adults with advanced     adults with advanced     adults with advanced
Superimposed text: Drug X is for        non-small cell lung      non-small cell lung      non-small cell lung
 adults with advanced non-small cell    cancer previously        cancer previously        cancer.
 lung cancer previously treated with    treated with platinum-   treated with platinum-  Superimposed text: Drug
 platinum-based chemotherapy, who       based chemotherapy,      based chemotherapy,      X is for adults with
 have a certain type of ALK gene.       who have a certain       who have a certain       advanced non-small
                                        type of ALK gene.        type of ALK gene.        cell lung cancer.
                                       Superimposed text: Drug  Superimposed text: Drug
                                        X is for adults with     X is for adults with
                                        advanced non-small       advanced non-small
                                        cell lung cancer.        cell lung cancer
                                                                 previously treated
                                                                 with platinum-based
                                                                 chemotherapy, who have
                                                                 a certain type of ALK
                                                                 gene.
----------------------------------------------------------------------------------------------------------------
Note. Study 2 will use the overall survival ad from Study 1.

                                       Table 3--Study 2 Design: Hematology
----------------------------------------------------------------------------------------------------------------
                                             Indication presentation
-----------------------------------------------------------------------------------------------------------------
                                                                                Material information
Material information in  superimposed  Material information in  Material information in    not in superimposed
              text only                       audio only           superimposed text +        text or audio
                                                                         audio                  (Control)
----------------------------------------------------------------------------------------------------------------
Audio: Drug Y is used to treat         Audio: Drug Y is used    Audio: Drug Y is used    Audio: Drug Y is used
 multiple myeloma.                      to treat multiple        to treat multiple        to treat multiple
Superimposed text: Drug Y is used to    myeloma in combination   myeloma in combination   myeloma.
 treat multiple myeloma in              with dexamethasone, in   with dexamethasone, in  Superimposed text: Drug
 combination with dexamethasone, in     people who have          people who have          Y is used to treat
 people who have received at least      received at least        received at least        multiple myeloma.
 three prior medicines to treat         three prior medicines    three prior medicines
 multiple myeloma.                      to treat multiple        to treat multiple
                                        myeloma.                 myeloma.
                                       Superimposed text: Drug  Superimposed text: Drug
                                        Y is used to treat       Y is used to treat
                                        multiple myeloma.        multiple myeloma in
                                                                 combination with
                                                                 dexamethasone, in
                                                                 people who have
                                                                 received at least
                                                                 three prior medicines
                                                                 to treat multiple
                                                                 myeloma.
----------------------------------------------------------------------------------------------------------------
Note. Study 2 will use the overall survival ad from Study 1.

    FDA estimates the burden of this collection of information as
follows:

                                 Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total  annual   Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive Interview screener..              30               1              30  0.08 (5 minutes)             2.4
Cognitive Interviews..........              18               1              18  1 (60 minutes)..              18
Pretests 1 and 2 screener.....             200               1             200  0.08 (5 minutes)              16
Pretests 1 and 2..............             120               1             120  0.33 (20                    39.6
                                                                                minutes).
Study 1 screener..............           1,167               1           1,167  0.08 (5 minutes)           93.36
Study 1.......................             700               1             700  0.33 (20                     231
                                                                                minutes).
Study 2 screener..............             867               1             867  0.08 (5 minutes)           69.36
Study 2.......................             520               1             520  0.33 (20                   171.6
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          641.32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references are on display with 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; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. 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. Kim, J., J. Gao, L. Amiri-Kordestani, et al., ``Patient-Friendly
Language to Facilitate Treatment Choice for Patients with Cancer.''
The Oncologist, 10.1634/theoncologist.2018-0761, 2019. Available
from: http://theoncologist.alphamedpress.org/content/early/2019/05/16/theoncologist.2018-0761.short?rss=1.
2. Aikin, K.J., A.C. O'Donoghue, C.M. Squire, et al., ``An Empirical
Examination of the FDAAA-Mandated Toll-Free Statement for Consumer
Reporting of Side Effects in Direct-to-Consumer Television
Advertisements.'' Journal of Public Policy & Marketing, 35(1):108-
123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C. O'Donoghue, et al.,
``Attention to and Distraction from Risk Information in Prescription
Drug Advertising: An Eye-Tracking Study.'' Journal of Public Policy
& Marketing, 36(2):236-245, 2017.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13128 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P