DRAFT 6-23-06

Table 1. Parameter values for eradication model (revised from Sisterson et al. 2004).

Default values are indicated by an asterisk.

Page 1 of 2

_______________________________________________________________________

Parameter							Values	________________

Adults

Mean % of adults that leave their natal field			10, 55*, 75

Number of eggs per female per day in Bt cotton fields	10

Number of eggs per female per day in non-Bt cotton fields	10

Mean % of adults that die each day				10

Egg-pupae

Mutation rate (from S to R per allele)				5 x 10-5

Mean % of SS and RS killed in non-Bt cotton fields		79.2

Mean % of RR killed in non-Bt cotton fields			79.2, 81.3*(10% fitness cost)

Mean % of SS and RS killed in Bt cotton fields		99.8a, 100*

Mean % of RR killed in Bt cotton fields			79.2, 83.2*(incomplete R=0.9)

Development time (degree days)				433

Mean % of larvae that die during overwintering		95

Region

Initial R allele frequency					0.0001, 0.001*, 0.01

Number of fields						400*, 900

Size of fields							15 hectares

Percentage of Bt fields						80, 85, 90, 95, 100*

Percentage of Bt plants in Bt fields				99a, 100*

Distribution of fields						Random

Carrying capacity per field					4,200,000

Initial overwintering larvae per field				2900, 29,000*, 290,000

a 99.8% mortality of RS and SS simulates 100% Bt fields that have 99% Bt cotton plants and 1% non-Bt cotton plants (contaminants);  100% die on the Bt plants, 79.2% die on the non-Bt plants

(0.99 X 100% + 0.01 X 79.2% = 99.8%)

Steriles

Release period							May 1-Oct 15 (1st bloom to defoliation)

Frequency of releases in each field				1 per 3 days per field

Sex ratio of steriles						1 female: 1 male

Steriles per ha per release in Bt cotton fields			0, 25, 75*, 150

(=0, 50, 150, 300 per week per ha)

Steriles per ha per release in non-Bt cotton fields		0, 100, 500*, 1000

								(=0, 200, 1000, 2000 per week per ha)

Pheromone ropes only in non-Bt cotton fields

All non-Bt fields treated once early in season			May 17-June 20 (6-leaf stage)

Daily % reduction in fecundity caused by pheromone ropes	20, 40*, 60 for 30 days

Insecticide & pheromone sprays only in non-Bt cotton fields

Spray threshold (check sterile male:native male ratio weekly) 	≥60 no spray

								30-59 spray pheromone

								0-29 spray pheromone + insecticide

Daily reduction in fecundity caused by pheromone sprays 	20, 40*, 60 for 14 days

Mean % of adults killed daily by insecticide			37 per day for 5 days

Mean % of eggs killed daily by insecticide			95 per day for 5 days

Larvae are not killed by sprays


[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Page 29163]
[FR Doc No: 2022-10219]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0016]

Meetings To Implement Pandemic Response Voluntary Agreement Under
Section 708 of the Defense Production Act

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice of meeting cancellations.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) previously
announced a series of meetings under the Plan of Action to Establish a
National Strategy for the Coordination of National Multimodal
Healthcare Supply Chains to Respond to COVID-19, to implement the
Voluntary Agreement for the Manufacture and Distribution of Critical
Healthcare Resources Necessary to Respond to a Pandemic. The meetings
listed below have been cancelled.

DATES:  The meetings scheduled for the dates listed below were
cancelled:
     Wednesday, March 16, 2022, from 1 p.m. to 3 p.m. Eastern
Time (ET).
     Wednesday, March 30, 2022, from 1 p.m. to 3 p.m. ET.
     Wednesday, April 13, 2022, from 1 p.m. to 3 p.m. ET.
     Wednesday, April 27, 2022, from 1 p.m. to 3 p.m. ET.
     Wednesday, May 11, 2022, from 1 p.m. to 3 p.m. ET.
     Wednesday, May 25, 2022, from 1 p.m. to 3 p.m. ET.

FOR FURTHER INFORMATION CONTACT: Mary Anne Lyle, Office of Business,
Industry, and Infrastructure Integration, via email at
[email protected] or via phone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On March 10, 2022, FEMA announced a series
of meetings to be held pursuant to section 708(h)(8) of the Defense
Production Act (DPA), 50 U.S.C. 4558(h)(8).\1\ The meeting scheduled
for March 2, 2022, took place as planned, but in light of other efforts
to address the draft recommendations of the National Multimodal
Healthcare Supply Chains Plan of Action, as well as incremental
improvement in the overall multimodal transportation situation, the
Sponsor of the Voluntary Agreement,\2\ the FEMA Administrator, no
longer sees the need to conduct the other meetings, and has cancelled
them.
---------------------------------------------------------------------------

    \1\ 87 FR 13742 (Mar. 10, 2022).
    \2\ ``[T]he individual designated by the President in subsection
(c)(2) [of section 708 of the DPA] to administer the voluntary
agreement, or plan of action.'' 50 U.S.C. 4558(h)(7).

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-10219 Filed 5-11-22; 8:45 am]
BILLING CODE 9111-19-P


[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Page 55886]
[FR Doc No: 2018-24483]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9986-25-Region 3]

Delegation of Authority to the Commonwealth of Virginia To
Implement and Enforce Additional or Revised National Emission Standards
for Hazardous Air Pollutants Standards and New Source Performance
Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of delegation of authority.

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

SUMMARY: On September 25, 2018, the Environmental Protection Agency
(EPA) sent the Commonwealth of Virginia (Virginia) a letter
acknowledging that Virginia's delegation of authority to implement and
enforce the National Emissions Standards for Hazardous Air Pollutants
(NESHAPs) and New Source Performance Standards (NSPS) had been updated,
as provided for under previously approved delegation mechanisms. To
inform regulated facilities and the public, EPA is making available a
copy of EPA's letter to Virginia through this notice.

DATES: On September 25, 2018, EPA sent Virginia a letter acknowledging
that Virginia's delegation of authority to implement and enforce
Federal NESHAPs had been updated.

ADDRESSES: Copies of documents pertaining to this action are available
for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103-2029. Copies of
Virginia's submittal are also available at the Virginia Department of
Environmental Quality, 1111 East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Riley Burger,<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION: On February 22, 2018, Virginia notified EPA
that Virginia had updated its incorporation by reference of Federal
NESHAPs to include many such standards, as they were published in final
form in the Code of Federal Regulations dated July 1, 2017. On
September 25, 2018, EPA sent Virginia a letter acknowledging that
Virginia now has the authority to implement and enforce the NESHAPs as
specified by Virginia in its notice to EPA, as provided for under
previously approved automatic delegation mechanisms. All notifications,
applications, reports, and other correspondence required pursuant to
the delegated NESHAPs must be submitted to both the EPA, Region III and
to the Virginia Department of Environmental Quality, unless the
delegated standard specifically provides that such submittals may be
sent to EPA or a delegated State. In such cases, the submittals should
be sent only to the Virginia Department of Environmental Quality. A
copy of EPA's letter to Virginia follows:

Michael G. Dowd, Director, Air Division, Virginia Department of
Environmental Quality, P.O. Box 1105, Richmond, Virginia 23218

    Dear Mr. Dowd: The United States Environmental Protection Agency
(EPA) has previously delegated to the Commonwealth of Virginia
(Virginia) the authority to implement and enforce various federal
New Source Performance Standards (NSPS), National Emission Standards
for Hazardous Air Pollutants (NESHAP), and National Emission
Standards for Hazardous Air Pollutants for Source Categories (MACT
standards) which are found at 40 CFR parts 60, 61 and 63,
respectively. In those actions, EPA also delegated to Virginia the
authority to implement and enforce any future federal NSPS, NESHAP
or MACT Standards on the condition that Virginia legally adopt the
future standards, make only allowed wording changes, and provide
specified notice to EPA.
    In a letter dated February 22, 2018, Virginia submitted to EPA
revised versions of Virginia's regulations which incorporate by
reference specified federal NSPS, NESHAP and MACT standards, as
those federal standards had been published in final form in the Code
of Federal Regulations dated July 1, 2016. Virginia committed to
enforcing the federal standards in conformance with the terms of
EPA's previous delegations of authority and made only allowed
wording changes.
    Virginia stated that it had submitted the revisions ``to retain
its authority to enforce the NSPSs and NESHAPs under the delegation
of authority granted by EPA on August 27, 1981 (46 FR 43300) and to
enforce the MACT standards under the delegation of authority granted
by EPA on January 26, 1999 (64 FR 3938) and January 8, 2002 (67 FR
825).''
    Virginia provided copies of its revised regulations which
specify the NSPS, NESHAP and MACT Standards which it had adopted by
reference. Virginia's revised regulations are entitled 9 VAC 5-50
``New and Modified Stationary Sources,'' and 9 VAC 5-60 ``Hazardous
Air Pollutant Sources.'' These revised regulations have an effective
date of February 21, 2018.
    Based on Virginia's submittal, EPA acknowledges that EPA's
delegations to Virginia of the authority implement and enforce EPA's
NSPS, NESHAP, and MACT Standards have been updated, as provided for
under the terms of EPA's previous delegation of authority actions,
to allow the Virginia to implement and enforce the federal NSPS,
NESHAP and MACT standards which Virginia has adopted by reference as
specified in Virginia's revised regulations 9 VAC 5-50 and 9 VAC 5-
60, both effective on February 21, 2018.
    Please note that on December 19, 2008, in Sierra Club v. EPA,\1\
the United States Court of Appeals for the District of Columbia
Circuit vacated certain provisions of the General Provisions of 40
CFR part 63 relating to exemptions for startup, shutdown, and
malfunction (SSM). On October 16, 2009, the Court issued a mandate
vacating these SSM exemption provisions, which are found at 40 CFR
63.6(f)(1) and (h)(1).
---------------------------------------------------------------------------

    \1\ Sierra Club v. EPA, 551 F.3rd 1019 (D.C. Cir. 2008).
---------------------------------------------------------------------------

    Accordingly, EPA no longer allows sources the SSM exemption as
provided for in the vacated provisions at 40 CFR 63.6(f)(1) and
(h)(1), even though EPA has not yet formally removed these SSM
exemption provisions from the General Provisions of 40 CFR part 63.
Because Virginia incorporated 40 CFR part 63 by reference, Virginia
should also no longer allow sources to use the former SSM exemption
from the General Provisions of 40 CFR part 63 due to the Court's
ruling in Sierra Club v. EPA.
    EPA appreciates Virginia's continuing NSPS, NESHAP and MACT
standards enforcement efforts, and also Virginia's decision to take
automatic delegation of additional or updated NSPS, NESHAP and MACT
standards by adopting them by reference.

    This notice acknowledges the update of Virginia's delegation of
authority to implement and enforce NESHAP, NSPS, and MACT.

    Dated: October 31, 2018.
Cristina Fernandez,
Director, Air Protection Division, Region III.
[FR Doc. 2018-24483 Filed 11-7-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31083-31085]
[DOCID:fr30my08-40]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

May 22, 2008.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER96-719-021; EL05-59-004.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company submits its Refund Report
in compliance with the Commission's 4/4/08 Order.
    Filed Date: 05/15/2008.
    Accession Number: 20080521-0078.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER96-1551-020; ER01-615-016; ER07-965-002.
    Applicants: Public Service Company of New Mexico; EnergyCo
Marketing and Trading, LLC.
    Description: Public Service Company of New Mexico et al. submits
revised market-based rate tariffs and tariffs for the sale of capacity
and energy subject to cost-based rate caps.
    Filed Date: 05/15/2008.
    Accession Number: 20080521-0080.

    Comment Date: 5 p.m. Eastern Time on Thursday, June 5, 2008.

    Docket Numbers: ER00-1053-021.
    Applicants: Maine Public Service Company.
    Description: Maine Public Service Co submits the Settlement
Agreement re its 2007 Informational Filing.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0130.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER05-1056-003; ER06-1548-001.
    Applicants: Chehalis Power Generating, L.P.
    Description: Chehalis Power Generating, LP submits its compliance
filing of its revised Rate Schedule FERC 2.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0133.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER06-95-002.
    Applicants: Pacific Gas and Electric Company.
    Description: Compliance Refund Report (Compliance Only) of Pacific
Gas & Electric Company.
    Filed Date: 02/04/2008.
    Accession Number: 20080204-5038.
    Comment Date: 5 p.m. Eastern Time on Monday, June 2, 2008.

    Docket Numbers: ER06-615-023; ER07-1257-005.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits a
compliance filing in compliance with FERC's 3/24/08 Order.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0134.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-852-001.
    Applicants: Glacial Energy Holdings.
    Description: Glacial Energy Holdings submits an amendment to the 4/
18/08 application.
    Filed Date: 05/20/2008.
    Accession Number: 20080521-0132.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 10, 2008.

    Docket Numbers: ER08-980-000.
    Applicants: Alliant Energy Corporate Services, Inc.
    Description: Alliant Energy Corporate Services, Inc submits a
Wholesale Power Supply Agreement with Jo-Carroll Energy, Inc.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0135.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-981-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc submits FERC Electric Rate
Schedule, Fourth Revised Volume 8 etc.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0136.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-982-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits an executed
Interconnection Service Agreement with Forked River Power LLC et al.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0137.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-983-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Service
Agreement for Network Integration Transmission Service with City of
Coffeyville, KS.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0138.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-985-000.
    Applicants: New York Independent System Operator, In.
    Description: National Grid USA Service Company, Inc et al. submit
an executed Small Generator Interconnection Agreement among NYISO,
National Grid, and Innovative Energy Systems, Inc.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0140.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-986-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corp submits a notice
of cancellation of a firm point-to-point transmission service agreement
with City of Coffeyville, Kansas.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0141.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-987-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Co submits a Service
Agreement for Wholesale Distribution Service and Interconnection
Agreement with McAllister Ranch Irrigation District.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0142.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-988-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc and the Kansas Gas and Electric Co
submits Second Revised Sheet 11 and 1 to the Wholesale Electric Service
Agreement commencing 2/1/88, designated as First revised Rate Schedule
171.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0143.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.

    Docket Numbers: ER08-989-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy Inc submits Petition for Approval of
Settlement Agreement.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0144.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.
    Take notice that the Commission received the following open access
transmission tariff filings:
    Docket Numbers: OA08-117-000.
    Applicants: Avista Corporation.
    Description: Avista Corp submits an informational filing of
Operational Penalty Assessments and Distributions as required by Order
890 and 890-A.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0127.
    Comment Date: 5 p.m. Eastern Time on Monday, June 9, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling

link to log on and submit the intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, D.C. There is an eSubscription
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed dockets(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-12039 Filed 5-29-08; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM

To:	Margaret Sheppard; U.S. EPA

Cc:	Monica Shimamura; U.S. EPA

From:	Sarah Menassian, Kara Altshuler and Mark Wagner; ICF International

Date:	September 29, 2009

Re:	Decomposition of Solvay Foam Blowing Agent Blend

(EPA Contract EP-W-06-008, TO 038, Task 5)

ICF has reviewed information provided by Solvay regarding the potential
decomposition of their foam blowing agent blends containing HFC-365mfc
and HFC-245fa.  Information was provided regarding the decomposition of
HFC-365mfc, but information was not available for the blend.

In 2003, ICF analyzed the decomposition of a foam blowing agent
consisting of HFC-245fa and HCFC-22 to cis- and trans-HFO-1234ze.  It
was found that blends with higher concentrations of HFC-245fa resulted
in higher quantities of decomposition products.  However, pure
HFO-1234ze has since been approved for use in foam-blowing applications
and will be used in much greater quantities than those produced by
decomposition of HFC-245fa to HFO-1234ze.  Therefore, decomposition of
HFC-245fa to HFO-1234ze is not expected to pose a toxicity threat.

Further, available information on HFC-365mfc indicates that its
decomposition will be very limited (i.e., 0.1 percent or less).
Decomposition products expected include cis- and
trans-1,1,1,3-tetrafluorobut-2-ene and 1,1,3,3-tetrafluorobut-1-ene.
While specific toxicity data were not available for these compounds, we
expect they should be similarly toxic to other fluorinated alkenes
previously reviewed.  As these compounds will be present in very low
concentrations, there is not a significant toxicity concern.

Any potential effects stemming from the blending of these two chemicals
cannot be determined without testing data for the blend; however based
on the available information, exposure to the decomposition products of
HFC-365mfc and HFC-245fa is not expected to be a significant
toxicological concern.

Please contact Mark Wagner<PHONE_NUMBER> with questions or comments.

 Memorandum entitled: “HFC-245fa/ HCFC-22 Foam Blowing Decomposition
Questions” (deliverable under EPA Contract Number 68-D-00-266, WA 2-04
Task 02).

Decomposition of Solvay Foam Blowing Agent Blend – Version 1

September 29, 2009

Page   PAGE  1


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12503-12506]
[FR Doc No: 2016-05233]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0735]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Superimposed Text in Direct-to-Consumer Promotion of
Prescription Drugs

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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled ``Superimposed Text in
Direct-to-Consumer Promotion of Prescription Drugs.'' This study will
examine how the size and presentation of superimposed text (supers)
influences the comprehension of direct-to-consumer (DTC) television
advertisements for prescription drugs.

DATES:  Submit either electronic or written comments on the collection
of information by May 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-0735 for ``Superimposed Text in Direct-to-Consumer Promotion
of Prescription Drugs.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs--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 (the 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 proposed study seeks to extend previous research on the effects
of supers in general print and television advertising to today's modern
DTC pharmaceutical promotion. Although earlier research on the effects
of supers in other consumer settings suggests that altering text size
can influence consumer comprehension of information, it is unclear if
these findings extend to DTC promotion of prescription drugs and are
applicable over 20 years later when viewing promotional materials using
today's modern technologies (e.g., tablets). Moreover, other factors
such as text/background contrast may also influence both the
understanding of the superimposed information (Ref. 1) and the effects
of text size. The proposed research seeks to update these earlier
findings and also to answer new questions concerning presentation of
supers.
    Part of FDA's public health mission is to ensure the safe use of
prescription drugs; therefore, it is important that the information
provided in DTC promotion is clear and understandable for consumer
audiences, avoids use of deceptive or misleading claims, and

achieves ``fair balance'' in presentation of benefits and risks. For
example, varying presentation formats including type size, bulleting,
amount of white space, and use of ``chunking'' or headlines can all
influence consumer perceptions of information (Ref. 2). A systematic
review of presentation formats in prescription drug labeling found that
these ``clear communication'' characteristics positively influenced
consumer's comprehension of information and prescription drug behaviors
(i.e., adherence) (Ref. 3). In one randomized controlled study, young
and older adults were presented with 12 otherwise identical over-the-
counter drugs bottled with varied container labels along various
dimensions, one of which was text size (7 vs. 10 point). While younger
participants performed equally well with both font sizes, elderly
populations had significantly reduced recall and comprehension when
exposed to the smaller text size (Ref. 4). Another study found that
both young and older populations preferred the larger text size and
that patients read labels with larger font more rapidly and accurately
than labels with smaller font (Ref. 5). Although these studies were
specific to prescription drug container labels, it is plausible that
the effects of font sizes would be applicable to drug promotion.
    Some early research in the late 1980s and 1990s examined the size
of supers in print and television advertising topics outside of
prescription drugs (Refs. 6, 7, and 8). These studies all generally
found that the text size of the super was associated with
comprehension, such that the larger text sizes increased understanding
of the material (and, conversely, smaller text sizes interfered with
comprehension). For example, Foxman and colleagues (Ref. 6) found that
whereas ``small'' text size (> \1/2\ inch size) was associated with
accurate comprehension for 59 percent of respondents, ``large'' text
size (> \1/2\ inch size) was associated with comprehension for 79
percent of respondents. Studies by other researchers (Refs. 7 and 8)
found similar patterns such that increasing the text size of supers
generally corresponded with increased comprehension.
    We know of no studies that have examined other commonly variable
factors, such as text/background contrast, that may interact with text
size to influence comprehension. Early research on text readability
determined that the contrast between text and background has a
consistent but small effect. Specifically, while the contrast of color
has a small effect (Ref. 9), the contrast in brightness, or luminance,
makes the largest difference (Ref. 10). These studies showed that black
text on a white background results in the highest readability (Ref.
11), but that other effects of color contrasts are unclear (Ref .1).
Some studies have demonstrated that contrast interacts with text size,
such that contrast becomes a more important discriminator as the text
size decreases (Ref. 12).
    The earlier research on supers is limited in their applicability to
today's DTC promotion in several ways. None of these studies
specifically focused on prescription drug promotion, but rather
explored the effects of superimposed text in a variety of social and
consumer advertising contexts. Another limitation is that these earlier
studies were conducted with populations (i.e., undergraduate students)
that are not representative of today's prescription drug users. It is
not clear if the effects of supers would translate to older adult
populations, who represent the greatest proportion of prescription drug
users (Ref. 13). Perhaps most importantly, it is unknown if the effects
of supers would be found today, considering the prevalent use of modern
technologies, including large (40+ inches) TV screens and personal
tablets for online viewing. Our proposed study seeks to address these
unanswered questions regarding the use of supers in prescription drug
promotion.

II. General Research Questions

    1. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the noticeability,
recall, and perceived importance of the super information?
    2. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the recall of and
attitudes toward the promoted drug?
    3. Are there any interaction effects among any combination of
independent variables?

III. Design

    To test these research questions, we will conduct one randomized
controlled study. We will examine reactions to supers in a fictitious
DTC prescription drug promotional video on two types of viewing devices
with a general population sample. The study design will be a 3 x 2 x 2
factorial design, where participants are randomly assigned to 1 of 12
experimental study arms differentiated by:
     Super text size (small, medium, large);
     Device type (television, tablet);
     Super text contrast (high, low).

                                                    Table 1--Design and Cell Sizes for Main Study \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Device Type                                             TV                                   Tablet
--------------------------------------------------------------------------------------------------------------------------------------------    Total
                          Super Size                              Small        Medium       Large        Small        Medium       Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contrast:
    High.....................................................          106          106          106          106          106          106          636
    Low......................................................          106          106          106          106          106          106          636
                                                              ------------------------------------------------------------------------------------------
        Total................................................          212          212          212          212          212          212        1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The sample will be split evenly across 3 cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.

    For both the pretest and main study, we will work with two market
research firms to recruit adult participants and conduct in-person data
collection in three U.S. cities: Los Angeles, CA; Cincinnati, OH; and
Tampa, FL. In addition to our aim for regional variation, we selected
these three cities with the aim of recruiting a sample that is diverse
on gender, race/ethnicity, education, and age characteristics.
    Participants from the general population will be invited to a
market research facility to watch one video for a fictional
prescription drug that treats asthma. In-person administration of study
procedures will enable us to control the television and tablet watching
experience in terms of size, distance, and other variables.
Participants will watch the video twice and then answer questions
addressing recall of risks and benefits, perceptions of risks and
benefits, and questions

regarding the salience of information in text. The questionnaire is
available upon request. Participation is estimated to take
approximately 20 minutes.
    To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
    Pretesting will take place before the main study to select super
sizes for the main study and to evaluate the procedures and measures
that will be used. We will exclude individuals who work in health care
or marketing settings because their knowledge and experiences may not
reflect those of the average consumer. We conducted a priori power
analyses to determine sample sizes for the pretest and the main study.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
                                                   Pretesting
----------------------------------------------------------------------------------------------------------------
No. to complete the screener               338               1             338  0.08 (5 minutes)              27
 (assumes 50% eligible).
No. of completes..............             240               1             240  0.33 (20                      79
                                                                                minutes).
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
No. to complete the screener             1,785               1           1,785  0.08 (5 minutes)             143
 (assumes 50% eligible).
No. of completes..............           1,272               1           1,272  0.33 (20                     420
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             669
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. References

1. Hall, R.H. and P. Hanna, ``The Impact of Web page Text-Background
Colour Combinations on Readability, Retention, Aesthetics and
Behavioural Intention,'' Behaviour & Information Technology,
2004;23:183-195.
2. Baur, C. and C. Prue, ``The CDC Clear Communication Index Is a
New Evidence-Based Tool to Prepare and Review Health Information,''
Health Promotion Practice, 2014;15:629-637.
3. Shrank, W., J. Avorn, C. Rolon, et al., ``Effect of Content and
Format of Prescription Drug Labels on Readability, Understanding,
and Medication Use: A Systematic Review,'' The Annals of
Pharmacotherapy, 2007;41:783-801.
4. Wogalter, M.S. and W.J. Vigilante, Jr., ``Effects of Label Format
on Knowledge Acquisition and Perceived Readability by Younger and
Older Adults,'' Ergonomics, 2003;46:327-344.
5. Smither, J.A.A. and C.C. Braun, ``Readability of Prescription
Drug Labels by Older and Younger Adults,'' Journal of Clinical
Psychology in Medicine Settings, 1994;1:149-159.
6. Foxman, E.R., D.D. Muehling, and P.A. Moore, ``Disclaimer
Footnotes in Ads: Discrepancies Between Purpose and Performance,''
Journal of Public Policy & Marketing, 1988;7:127-137.
7. Murray, N.M., L.A. Manrai, and A.K. Manrai, ``Public Policy
Relating to Consumer Comprehension of Television Commercials: A
Review and Some Empirical Results,'' Journal of Consumer Policy,
1993;16:145-170.
8. Manrai, L.A., A.K. Manrai, and N. Murray, ``Comprehension of
Info-Aid Supers in Television Advertising for Social Ideas:
Implications for Public Policy,'' Journal of Business Research,
1994;30:75-84.
9. Hill, A. and L. Scharff, ``Readability of Computer Displays as a
Function of Colour, Saturation, and Background Texture.'' In: D.
Harns (Ed.) Engineering Psychology and Cognitive Ergonomics, (Vol.
4) Ashgate, Aldershot, United Kingdom.
10. Shieh, K.-K. and C.-C. Lin, ``Effects of Screen Type, Ambient
Illumination, and Color Combination on VDT Visual Performance and
Subjective Preference,'' International Journal of Industrial
Ergonomics, 2000;26:527-536.
11. Tinker, M.A. and D.G. Paterson, ``Studies of Typographical
Factors Influencing Speed of Reading. VII. Variations in Color of
Print and Background,'' Journal of Applied Psychology, 1931;15:471-
479.
12. Legge, G.E., G.S. Rubin, and A. Luebner, ``Psychophysics of
Reading--V. The Role of Contrast in Normal Vision,'' Vision
Research, 1987;27:1165-1177.
13. Kaufman, D.W., J.P. Kelly, L. Rosenberg, et al., ``Recent
Patterns of Medication Use in the Ambulatory Adult Population of the
United States: The Slone Survey,'' The Journal of the American
Medical Association, 2002;287:337-344.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05233 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P