  SEQ CHAPTER \h \r 1

The SunWise Program

ICR # 1904.06

July 22, 2010

U. S.  Environmental Protection Agency

Office of Air and Radiation

Part A of the Supporting Statement

	Identification of the Information Collection

1(a)	Title of Information Request

The title of this Information Collection Request (ICR) is The SunWise
Program (ICR# 1904.03).

1(b)	Short Characterization/Abstract

The SunWise Program was initiated in 1998 through a statutory mandate
under Title IV of the Clean Air Act.  The long term objective of the
SunWise Program is to reduce the incidence of, and morbidity and
mortality from, skin cancer, cataracts, and other UV-related health
effects in the United States.  Short term objectives include:1) reducing
the risk of childhood overexposure to the sun by changing the knowledge,
attitudes, and behaviors of elementary school children and their care
givers; and 2) improving the availability of accurate, timely, and
useful UV data directly to schools and communities across the United
States.

The SunWise Program builds on traditional health education practices
through the use of existing curricula, learning standards, scientific
strategies, and evaluation mechanisms.  The Program is a collaborative
effort of schools, communities, health professionals, educators,
environmental organizations, meteorologists, local governments, federal
agencies, and others.  Participating schools sponsor classroom and
school activities to raise children’s awareness of stratospheric ozone
depletion, UV radiation, and the largely preventable health risks from
overexposure to the sun, as well as simple sun safety practices.  All
educators interested in participating in this partnership program are
asked to register using the online form
(www.epa.gov/sunwise/becoming.html and
www.epa.gov/sunwise/becoming_partner.html) or a hard copy version
distributed by EPA.  EPA will use the information provided through this
registration to maintain a database of participating schools and
organizations and a mailing list for information distribution purposes.
Participating schools and organizations receive a variety of materials,
including a classroom “Tool Kit” of games, songs, puzzles, story
books, videos, access to the internet UV intensity mapping/graphing
tools, and more. The Tool Kit also includes sample sun safety policies
and guidelines to help expand the sun safety message beyond the
classroom.

Teachers who sign up for SunWise are asked to complete a survey at the
end of program implementation.  Results of these surveys are used to
fine-tune existing SunWise materials and develop new ones that better
meet our participants’ needs.  Teachers are also asked if they are
interested in administering a brief survey to their students before and
after program implementation.  The surveys will be made available on the
SunWise website for all teachers that express interest in the survey
process.  Survey responses are voluntary and anonymous. The results from
the student surveys are used to gauge program effectiveness and also
help guide materials development.

Finally, SunWise is considering developing a new recognition program.
The program will recognize levels of SunWise teaching for interested
educators.  The more SunWise teaching and sun safety policy changes
implemented by an educator, the higher her/his level of SunWise (similar
to a bronze, silver and gold level) recognition.  Additionally, the
higher the involvement, the more recognition an educator would get.
Types of recognition could include access to discounts on partner
resources (for example, a discount on Crayola markers); extra resources
from EPA in the form of stickers, posters, coloring books, etc.; and/or
plaques, certificates and other “trophies” from EPA.  To set up the
program, EPA will need to identify what educators would want in terms of
recognition and incentives, and how the program should be run from a
logistical approach (verification of actions, etc.). The initial phase
would be comprised of a series of questions in the teacher survey
discussed above. Once the program is established, new questions may need
to be added to the teacher survey to track the actions taken, and verify
those actions. This new component would allow EPA to get a better grasp
on the level of engagement with SunWise, and would allow for future
effectiveness studies comparing impacts on student knowledge, attitude
and behavior with an educator’s level of engagement.

PREVIOUS TERMS OF CLEARANCE:

On November 2, 2001, OMB approved ICR #1904.01 with Terms of Clearance.
EPA has addressed OMB’s terms in the following manner.

This collection is approved in part and disapproved in part. EPA is
approved to collect registration information and to conduct the
requested student survey and teacher survey. These portions of the
collection are approved for two years, until November 2003. OMB
understands that EPA no longer intends to collect information under the
Parent Survey and the School Administrator Survey. These two surveys are
not approved. OMB has adjusted the burden of the collection accordingly
from EPA's request.

EPA Response: We will not be surveying parents or school administrators
under this ICR renewal.

As discussed in Part B of the revised supporting statement, EPA plans to
assess two sampling issues in Fall 2002 based on results from the first
year of the student survey: (1) whether it is necessary to include in
the sampling protocol an  approach to stratify between warm and cool
states, and (2) whether it is necessary to include an additional
sampling stage to sample classrooms within a school that has been
selected for participation. EPA should report to OMB its findings with
regard to these issues before beginning the second year of sampling, and
advise OMB whether it intends in the second year of the collection to
(1) stratify between warm and cool states in the first stage of
sampling,

EPA Response (sent to OMB on 8/29/02): We have conducted this analysis
and found no differences between the students in the 37 cooler states
versus the 13 warm states, as categorized by the UV Index values. We
measured change in scores from pretest to posttests on children's
knowledge of sun protection, attitudes toward the sun, and current sun
protection practices and found minimal differences in the change.
Therefore, with no differences between the two groups, there would be no
reason to stratify our findings.

and/or (2) add a sampling stage to sample classrooms within a selected
school.

EPA Response (sent to OMB on 8/29/02): We analyzed the composition of
registrants in the SunWise database by region of the country and the
number of schools that contained more than one classroom. It appears
that 75 percent of schools in warm and cool climates have no more than 1
classroom per school with negligible difference by region. There is
little evidence of clustering or differences in clustering between
regions of the country. If that were the case, we would have to account
for this effect by performing tests of intraclass correlation.

OMB also notes that EPA must include the OMB number, expiration date,
and Paperwork Reduction Act notice on the teacher survey before using
that instrument to collect information.

EPA Response: All information is now included on the teacher survey.
See attachment #1a and 1b for verification.

	Need for Use of the Collection

2(a)	Need/Authority For The Collection

This collection will be used for program material distribution and to
determine program effectiveness and participant satisfaction.  Educators
will be asked to fill out a simple registration form, which we use to
mail out the program materials and keep track of the Program’s:

	geographic reach (Which states/regions have SunWise schools?);

	grade-level and subject-matter distribution (How many 1st grade
teachers are using SunWise? How many math teachers are using SunWise?
etc.); and

	student participation level (How many students is SunWise potentially
reaching?).

This collection will include one survey for educators.  Specifically, a
teacher questionnaire will be distributed in order to measure educator
receptivity to new resources and experience with the SunWise Tool Kit
and educational resources. The data will be analyzed and results will
indicate the Program’s effect on participants’ sun-protection
knowledge, attitudes, and behaviors.  Responses to the collection of
information are voluntary.  All responses to the collection of
information remain anonymous and confidential.

The SunWise Program recognizes the challenge of measuring the progress
and evaluating the effectiveness of an environmental and public health
education program where the ultimate goal is to reduce risk and improve
public health.  Therefore, the continual and careful evaluation of
program effectiveness through a variety of means, including data from
pre- and post-intervention surveys, tracking and monitoring of classroom
activities and school policies, and advisory board meetings, is
necessary to monitor progress and refine the program.

2(b)	Practical Utility/Users of the Data

EPA/SunWise will use the survey results to review process and impact
results—including cost effectiveness—and adapt as appropriate its
messages, approaches, and materials.  Survey results will enable
EPA/SunWise to better meet the needs of its educator and student
participants, with the long range goal of reducing the incidence and
effects of skin cancer and other UV-related health problems among
children and adults.

3.  Nonduplication, Consultations, and Other Collection Criteria

3(a)	Nonduplication

The information required to complete the survey for The SunWise Program
is not duplicative of information otherwise available to EPA.  In the
early stages of the SunWise Program’s development in 1997, several
searches for information were completed in consult with external
stakeholders, including representatives from the following
organizations:

American Academy of Dermatology

American Cancer Society

Boston University Medical Center - Skin Oncology, Cancer Prevention &
Control Center

Centers for Disease Control and Prevention

National Association of Physicians for the Environment

National Safety Council

The Skin Cancer Foundation

Results from these consultations indicated that no other formal,
student-focused, sun safety programs were being implemented in the
United States, nor were surveys being conducted on attitudes and
practices of children relating to sun exposure.

Conducting timely and useful process evaluation is also of importance if
the SunWise Program is to continue providing high-grade and pertinent
resources for educators across the U.S.

3(b)	Public Notice Required Prior to ICR Submission to OMB

Official notice of this proposed collection appeared in the Federal
Register on Friday, May 21, 2003 (68 FR 27796).  No comments were
received. (WILL CHANGE with SECOND FEDERAL REGISTER NOTICE)

3(c)	Consultations

The following professionals were consulted during the development of the
three survey instruments:

		Alan Geller, Boston Medical Center, Skin Oncology Cancer Prevention &
Control Center,<PHONE_NUMBER>

		Dave Buller, PhD, AMC Cancer Research Center,<PHONE_NUMBER>

	Dr. Barbara Gilchrest, Chair, Department of Dermatology, Boston
University School of Medicine,<PHONE_NUMBER>

	Dr. Donald Miller, Assistant Professor of Epidemiology and Health
Policy, Boston University School of Medicine,<PHONE_NUMBER>

  	Dr. Amy Mack, Psy.D., ICF International,<PHONE_NUMBER>

3 (d)	Effects of Less Frequent Collection

SunWise depends on registration information to

	maintain an accurate list of participants; and

	ensure timely distribution of program materials and program updates to
participants.

SunWise depends on survey responses to

	help guide program development;

	measure participant satisfaction with the program;

         	test new ideas for recognition and incentives; and

	elicit basic information on attitudes and practices of children and
their caregivers relating to sun exposure.

Conducting the surveys and information collection less frequently may
slow down the Program’s ability to institute participants’ desired
changes.

3(e)	General Guidelines

All OMB guidelines will be adhered to by EPA/SunWise Program.

3(f)	Confidentiality

Names of participating schools and organizations may be made public.
All names of registered educators and other participating individuals
will remain confidential.  All teacher surveys can be completed on an
anonymous basis (no identifying information is included on the survey
forms), and responses to the collection of survey information will
remain confidential.  EPA and a contractor will analyze survey results
and proceed accordingly.

3(g) 	Sensitive Questions

The survey instruments of this ICR contain no sensitive questions.

4.	The Respondents and the Information Requested

4(a)	Respondent/SIC and NAICS Codes

Entities potentially affected by this action are educators of
elementary, middle, and high school students (SIC Div. I:  Group 8211,
NAICS code:  61111).

4(b)	Information Requested

The registration form (Attachment 1a and 1b, also available at
HYPERLINK "http://www.epa.gov/sunwise/becoming.html"
www.epa.gov/sunwise/becoming.html  and
www.epa.gov/sunwise/becoming_partner.html) is a simple, 10-minute
questionnaire that asks teachers to provide: the name and contact
information of the participating school; school composition (e.g. grade
levels); and information specific to the interest areas of the
registering teacher.  The purpose of this form is to ensure that EPA
distributes the most relevant education materials to all SunWise
participants.

The survey instruments covered under this ICR are as follows:

		Educator Evaluation of Activities (Attachments 2 & 3):  Educators will
be asked to evaluate their and their students’ receptivity to sun
safety resources provided by EPA.  Additionally, educators will be asked
about how they implemented the SunWise program in their school/classroom
and how many students they reached. Finally, educators will be asked
about areas for program growth, including their receptivity to new
resources and an updated recognition program.  Educator feedback about
the usefulness of classroom and school materials will be vital to the
refinement of program materials.  This information can be submitted
online.

Registration forms can be submitted electronically or in hard copy form
using envelopes provided by EPA.  The teacher survey is available
electronically.  Neither the registration nor the surveys require that
respondents keep records, make photocopies, or maintain files.

5.  The Information Collected

5(a)	Agency Activities

The Agency activities associated with registration of participants done
through the

SunWise Program consists of the following:

		Maintain participant database;

		Maintain mailing list for information distribution purposes.

The Agency activities associated with surveying done through the SunWise
Program consists of the following:

		Develop collection instruments;

		Answer respondent questions;

		Audit and/or review data submissions;

		Reformat the data;

 		Analyze the data and make program adjustments as needed;

		Store the data.

5(b)	Collection Methodology and Management

In collecting and analyzing the information associated with this ICR,
EPA will use electronic and hard-copy registration forms, and electronic
surveys.

Further details on the collection methodology and management for the
surveying and the certification program done through the SunWise Program
are provided below.

Registration

EPA routinely promotes the SunWise Program through presentations and
exhibits at meetings of nurses, teachers, and other educators.
Registrants provide their name and contact information, including the
name of their school, and state whether they are a classroom teacher,
health teacher, gym teacher, or school nurse on paper copy registration
forms. This information is then entered into a registration and tracking
system housed on EPA servers. In addition to the paper copy
registrations, EPA also registers educators and partners through an
online registration page housed on EPA’s SunWise program website. All
information collected is protected by adequate security and the system
is registered with the Automated System Security Evaluation and
Remediation Tracking (ASSERT) program to meet reporting requirements
under the Federal Information Security Management Act (FISMA).

The data is used to send registrants SunWise resources and alert
registrants of sun safety-related opportunities and new resources. No
personally identifiable information is shared outside of EPA and its
contractors and grantees.

Teacher Survey

Teacher surveys are conducted to determine:

		Students’ satisfaction with SunWise activities and resources;

 		Educators’ satisfaction with SunWise activities and resources;

 		How and how often educators are using the SunWise materials,
resources and programming;

   		How many students are receiving SunWise education;

 		If educators are sharing resources with other educators;

 		If school policies are being changed as a result of SunWise;

 		If educators are changing their own behavior;

 		If students are changing their behavior;

 		If educators have suggestions for improving or creating new SunWise
resources.

EPA will send a recruitment letter in the annual SunWise Monitor (the
program’s newsletter) and email in the Spring/Summer timeframe each
year encouraging all registered participants to take the SunWise
Educator Survey (attachment 2) hosted online. Educators will have the
option of taking the survey anonymously. Since this survey will be
voluntary and self-selecting, it will not be generalizable to the entire
pool of registered SunWise educators.

Part of the teacher survey will be an optional student pretest and
posttest survey using the validated student survey used in the previous
ICR period (attachment 3). There will be no control group for this
portion of the survey, and no generalizations will be made from this
data. It will serve as a useful way to see if students are still getting
the same benefit from the SunWise Tool Kit as in previous
quasi-experimental study designs testing the same concepts (see previous
ICR supporting statement for more details).

For those educators that choose to participate, they will provide
children with a double-sided, one page anonymous survey instrument.
After students complete the pre-test in the spring, teachers will lead
the SunWise lessons. SunWise will recommend teachers participating in
the posttest should administer the survey at least one month after
teaching the SunWise lessons, and will ask teachers to report what the
time gap was between SunWise lessons and administration of the survey.
EPA will not collect individual surveys—only aggregate classroom-level
data.

EPA will ensure the accuracy and completeness of collected information
by having all surveys reviewed by a contractor, grantee or EPA staff.
An annual statistical report will be developed.

5(c)	Small Entity Flexibility

Not applicable.

5(d)	Collection Schedule

All educators are required to register for the Program if they wish to
receive the Tool Kit (www.epa.gov/sunwise/becoming.html and
www.epa.gov/sunwise/becoming_partner.html) and regular program updates.

All program participants are invited to take the Educator Survey at any
time during the year. As noted above, recruitment letters will be sent
in the Spring/Summer to all registrants encouraging them to take the
educator survey, but it is always optional.

6.  Estimating the Burden and Cost of the Collection

6(a)	Estimating Respondent Burden

	EPA developed the SunWise Program Registration Form with the Agency’s
Internet Support Team in Research Triangle Park, North Carolina. Input
from a five-person focus group was used to determine average completion
time.  Teachers are asked to complete the registration form only once
during their participation in the program for a total registrant burden
of 10 minutes.

Annual estimated respondent burden:

Annual Respondent Burden- Registration

Registrant Group	Hour Burden

Educator	0.17

	During the development of the teacher survey, EPA, in consult with a
contractor and 9 educators reviewed the teacher survey to determine
appropriate content and survey completion time. If the teacher decides
to conduct the student pre- and posttest surveys it would take
additional time (noted below).

	During the development phase of the surveys, EPA, in consult with a
contractor, conducted a pilot survey with 9 respondents to determine
appropriate content and survey completion time.  The student survey will
be administered once in years 1 and 3 (i.e., pre-test for Group A and
post-test for Group B) and twice in year 2 (i.e., post-test from Group A
and pre-test for Group B).  Each survey will take approximately 10
minutes to complete, for an annual per student burden of 10 minutes.
The teacher survey is administered one time each year and takes
approximately 20 minutes to complete.

Annual estimated respondent burden:

Annual Respondent Burden- Surveys

Survey Group	Hour Burden

Student	0.17

Educator – No student survey	0.33

Educator – Yes student survey	0.5

6(b)	Estimating Respondents Costs

	The Bureau of Labor Statistics figures
(http://stats.bls.gov/news.release/ecec.t02.htm)  were used to determine
labor costs for these tables.  In order to account for benefits and
overhead, the average hourly wage rate of $36.41 for a teacher was
increased by 110% for a labor cost of $76.46 per hour for teachers.

	Annual Respondent Burden and Cost- Registration

Registrant Group	# of responses per participant	Hour Burden	Labor Cost

Educator	1	0.17	0.17 * $76.46 = $13.00

Annual Respondent Burden and Cost - Surveys

Survey Group	# of responses per participant	Hour Burden	Labor Cost

Student	1	0.17	1(0.17 * 0) = 0

Educator – No student survey	1	0.33	0.33 * $76.46 = $25.23

Educator – Yes student survey	1	0.5	0.5 * $76.46 = $38.23

	The respondents will have no capital/startup or O&M costs.

6(c)	Estimating Agency Burden and Cost

	Registration information collection is done primarily through a website
database feature.  The start-up cost associated with designing the
registration web page was approximately $25,000, but that money has
already been spent prior to previous ICRs.  Maintenance of the website
is estimated to involve three types of staff: EPA personnel, Grantees
through the Senior Environmental Employee (SEE) Program, and contractor
staff costing $100 per hour. The EPA employees will take 4 hours/month
or 48 hours per year. The cost of this labor is calculated based on a GS
13 Step 1 pay level living in Washington, DC ($68.26/hour using the
salary associated with this grade and step, multiplied by a benefits
factor of 1.6), making the total annual cost $3,276.48.  The Grantee
will spend 1500 hours per year at a cost of $30,000. The contractor will
spend 700 hours per year on the maintenance and enhancement of the of
the registration and tracking system at a cost of $70,000.

Finally, EPA will manually input all information received via hard-copy
registration form onto the database. The costs of this labor are
estimated to be 2000 hours per year at a SEE Program pay level of
$40,000 annually.

Agency Burden and Costs - Registration

	Burden Hours	Total Costs ($)

EPA (Annual)	4,248	$143,276.48

EPA (3-Year ICR)	12,744	$429,829.44

	The contractor (ICF International, with its subcontractors) assists EPA
in data collection and analysis.  The contractor also provided technical
support in the development of the surveys.  To perform these functions,
EPA will contract for a total of 150 professional hours over a
three-year period.  At an average rate of $100.00 per hour, the total
cost for the contractor is about $15,000 annually.  Agency burden to
manage this contract is estimated at 4 hours/month or 48 hours annually.
 The cost of this labor will be calculated based on a GS 13 Step 1 pay
level ($68.26/hour using the salary associated with this grade and step,
multiplied by a benefits factor of 1.6).  Total hours (48) amounts to a
total agency labor cost of $3,276.48/per annum.

	Agency Burden and Costs- Surveying

	Burden Hours	Total Costs ($)

EPA (Annual)	198	$18,276.48

EPA (3-Year ICR)	594	$54,829.44

6(d)	Estimating the Respondent Universe and Total Burden Costs

Registration

(A)

Number to register	(B)

Total Hours	(C)

Rate per hour ($)	(D)

# of responses	(E)

Total Cost

E=B*C

3,500 Educators	595	$76.46	3,500	$45,493.70

Total (Annual)                     	595

3,500	$45,493.70

ICR Total (3 years)             	1,785

10,500	 $136,481.10

Student and Teacher Surveys

(A)

Number to be surveyed	(B)

Total Hours	(C)

Rate per hour ($)	(D)

# of responses	(E)

Total Cost

E=B*C

1,000 Students per year	170	0	1,000	0

1,000  Educators – No student survey	333	$76.46	1,000	 $25,461.18

300  Educators – Yes student survey	150	$76.46	300	 $11,469.00

Average Total (Annual)                     	653

2,300	 $36,930.18

ICR Total (3 years)             	1,959

6,900	 $110,790.54

Total

ICR Total-Registration + Surveys + Tutorial (average annual)
	1,248

5,800	$82,423.88

ICR Total-Registration + Surveys + Tutorial (3 years)             	3,744

17,400	$247,271.64

6(e)Bottom Line Burden Hours and Cost Tables

Bottom Line Burden and Costs (3-Year ICR)

	Burden Hours	Total Costs ($)

Students	1,530	0

Educators	3,234	$247,271.64

EPA	13,338	$484,658.88

Subtotal (respondents)	4,764	$247,271.64

Subtotal (government)	13,338	$484,658.88

Total	18,102	$731,930.52

Bottom Line Burden and Costs (Average Annual)

	Burden Hours	Total Costs ($)

Students	510	0

Educators	1,078	$82,423.88

EPA	2,246	$61,552.96

Subtotal (respondents)	1,588	$82,423.88

Subtotal (government)	4,446	$161,552.96

Total	6,034	$243,976.84

6(f)	Reasons for Change in Burden

	Hours were removed for the certification program collection include in
the previous ICR.  Fewer hours for EPA are anticipated for the survey
work due to a decreased level of sophistication in the analysis and
decreased effort being needed to solicit survey responses. More hours
were added for teachers completing the educator survey and administering
the student survey. Finally, registering such a large number of teachers
has resulted in more hours needed at EPA. Hours and burden for educators
is about the same; hours for students has also decreased significantly.
The bottom line burden hours increased along with the total cost.

6(g)	Burden Statement

	The annual public reporting and record keeping burden for this
collection of information is estimated to average 10 minutes per
response for the registration, 10 minutes per response for the student
survey, 20 minutes per response for the educator survey without the
student survey, and 30 minutes per response for the educator survey with
the student survey.  Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, disclose,
or provide information to or for a Federal agency.  This includes the
time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information; processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.  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.  The OMB control numbers for EPA’s
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Part B of the Supporting Statement

SECTION I – SURVEY OBJECTIVES, KEY VARIABLES, AND OTHER

PRELIMINARIES

1(a) Survey Objectives

EPA’s Sunwise Program provides sun protection education via a
standardized curriculum to school children in grades K-8 in public,
parochial, and charter schools. More than 25,000 schools and 3,000,000
children have received SunWise education since the 1999-2000 school
year. EPA proposes to conduct customer satisfaction and process-related
evaluative surveys with the educators using the program.  The educator
survey will determine:

		Students’ satisfaction with SunWise activities and resources;

 		Educators’ satisfaction with SunWise activities and resources;

 		How and how often educators are using the SunWise materials,
resources and programming;

   		How many students are receiving SunWise education;

 		If educators are sharing resources with other educators;

 		If school policies are being changed as a result of SunWise;

 		If educators are changing their own behavior;

 		If students are changing their behavior;

 		If educators have suggestions for improving or creating new SunWise
resources.

The data will be analyzed and results, although not generalizable, will
indicate how the Program is being implemented and how it can improve.

1(b) Key Variables

satisfaction; frequency of use; number of students participating; number
and types of activities taught; school policy change; student and
teacher knowledge, attitudes and behavior; ways to improve the program

1(c) Statistical Approach

The primary objective in conducting the SunWise educator survey is to
how the SunWise program is being implemented, and how it can be
improved.  It is not practical to survey every educator that
participates in the SunWise Program, however. Since the results are not
intended to be generalizable to the complete pool of SunWise educators,
no statistical approach is needed.

1(d) Feasibility

EPA has reviewed the administrative procedures necessary to conduct the
SunWise educator survey and has determined that it is feasible to
continue with the survey.  The survey will be reviewed by educators and
survey specialists to ensure that the questions asked will reveal
sufficient information to evaluate the implementation of the SunWise
Program and how it could be improved, especially by adding an incentives
or “Levels of SunWise” recognition program. In addition, EPA has
funding to conduct the survey and provide the necessary analysis of the
resulting data.

SECTION II – SURVEY DESIGN

2(a) Target Population and Coverage

A convenience sample from all participating SunWise educators will be
used. SunWise educators are very diverse as some are in school and
others are outside of school.

2(b) Sample Design

School faculty and other educators register for the SunWise program
through EPA.  Registrants provide their name and contact information,
including the name of their school/organization, and state whether they
are a classroom teacher, health teacher, gym teacher, school nurse, or
other.  Recruitment letters will be sent to all registered SunWise
schools and partners.  However, many will not participate in the survey.

2(b)ii Sample Size

EPA anticipates distributing a survey to more than 35,000 formal and
informal educators, however only 1300 are expected to actually
participate in the survey.  This number is based on previous survey
participation.

2(b)iii Stratification Variables

None.

2(b)iv Sampling Method

Recruitment letters will be mailed to all educators who have registered
for the SunWise Program since the program began in 1999.  Those that
choose to participate will be reviewed and analyzed in the aggregate.

Inclusion criteria: Signed up with the SunWise program.

Exclusion criteria:  Incomplete educator survey.

2(b)v Multi-Stage Sampling

None.

2(c) Precision Requirements

2(c)i Precision Targets

N/A

2(c)ii Nonsampling Error

N/A

2(d) Questionnaire Design

The survey was derived from a SunWise instrument previously approved by
OMB on November 2, 2001 and April 15, 2008 (ICR #1904.01 and #1904.04).
The educator survey will be updated and tested with 9 educators before
launching on the website. It is based on the instrument approved by OMB
in the most recent ICR (ICR #1904.04, April 15, 2008). The student
survey was updated based on pilot testing with nine children aged 9 to
12 years old.

SECTION III – PRETESTS AND PILOT TESTS

To pilot test the revised SunWise educator survey, nine educators will
be randomly selected from among those attending conferences SunWise
attended.  All nine educators will complete the survey and then
participate in an interview with staff from EPA.  All nine pretest
respondents will be asked if the survey is relatively easy to understand
and complete. In addition, EPA will measure the time it takes for each
respondent to locate the data and complete the survey (estimated at less
than 20 minutes).

The pilot testing of the student survey was conducted under the previous
ICR (1904.04). It focused on the readability and understandability of
the questions and possible responses; following the pilot test, the
survey was revised to: (1) include instructions for students to turn
over the two-page, double-sided survey; (2) increase the font of
multiple choice instructions; (3) put all questions referring to “last
summer” together in a box at the end of the survey; (4) delete one
question that students found difficult; (5) revise the wording of
several questions to clarify question meaning; (6) add a new response
choice for why students do not wear sunscreen; and (7) increase the
response scale for several questions from a three-point to a five-point
scale.

SECTION IV – COLLECTION METHODS AND FOLLOW-UP

4(a) Collection Methods

All surveys have the option of being anonymous. Educator surveys are
administered online. Student surveys are administered in the classroom
by the educator; no individual data is shared with EPA. Additionally,
the surveys are anonymous, so no parental consent is needed.

4(b) Survey Response and Follow-Up

The target response rate is approximately 3 to 4 percent. Actual
response rate will be measured based on the number of educators that
submit surveys divided by the number of total educators signed up for
the program.  No additional follow-up will occur unless there are
questions with the survey, or if additional clarification is necessary
on suggested improvements.

SECTION V – ANALYZING AND REPORTING SURVEY RESULTS

5(a) Data Preparation

All survey data will automatically be entered into a database hosted on
the EPA server.

5(b) Analysis

The data obtained through this survey will be aggregated and analyzed
for the purpose of determining satisfaction; frequency of use; number of
students participating; number and types of activities taught; school
policy change; student and teacher knowledge, attitudes and behavior;
ways to improve the program. All of this information will give EPA
insight into how best to improve the program, and how the program is
being used. The results will not be generalizable to the total pool of
SunWise educators.

5(c) Reporting Results

The results of the survey will be written up in a summary report, which
may also be shared on the EPA website and with partners and interested
parties.  The raw survey data will be maintained by EPA contractor
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ഄ̍഍ഄࠍ഍ഈ഍䐍慲瑦ㄠ㈯⼴㜰഍ഈ഍ࠍ഍ഈ

഍


[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Page 63610]
[FR Doc No: 2020-22255]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90083; File No. SR-FICC-2020-009]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Designation of Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 1, To Introduce the Margin
Liquidity Adjustment Charge and Include a Bid-Ask Charge in the VaR
Charges

October 2, 2020.
    On July 30, 2020, Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ proposed rule change SR-
FICC-2020-009 to add two new charges to FICC's margin methodology.\3\
On August 13, 2020, FICC filed Amendment No. 1 to the proposed rule
change, to make clarifications and corrections to the proposed rule
change.\4\ The proposed rule change, as modified by Amendment No. 1,
was published for public comment in the Federal Register on August 20,
2020,\5\ and the Commission received no comments.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ FICC also filed the proposals contained in the proposed rule
change as advance notice SR-FICC-2020-802 with the Commission
pursuant to Section 806(e)(1) of the Dodd-Frank Wall Street Reform
and Consumer Protection Act entitled the Payment, Clearing, and
Settlement Supervision Act of 2010 (``Clearing Supervision Act''),
12 U.S.C. 5465(e)(1), and Rule 19b-4(n)(1)(i) of the Act, 17 CFR
240.19b-4(n)(1)(i).
    \4\ Amendment No. 1 made clarifications and corrections to the
description of the proposed rule change and Exhibits 3 and 5 of the
filing. On August 13, 2020, FICC filed Amendment No. 1 to the
advance notice to make similar clarifications and corrections to the
advance notice.
    \5\ Securities Exchange Act Release No. 89560 (August 14, 2020),
85 FR 51503 (August 20, 2020) (``Notice''). The advance notice, as
modified by Amendment No. 1, was published for public comment in the
Federal Register on September 4, 2020. Securities Exchange Act
Release No. 89718 (September 1, 2020), 85 FR 55341 (September 4,
2020) (File No. SR-FICC-2020-802). The comment period for the
advance notice, as modified by Amendment No. 1 closed on September
21, 2020, and the Commission received no comments.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \6\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the proposed rule change
is October 4, 2020.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the proposed rule change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \7\ and for
the reasons stated above, the Commission designates November 18, 2020
as the date by which the Commission shall either approve, disapprove,
or institute proceedings to determine whether to disapprove proposed
rule change SR-FICC-2020-009.
---------------------------------------------------------------------------

    \7\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-22255 Filed 10-7-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 17, 2007 (Volume 72, Number 241)]
[Rules and Regulations]
[Page 71245-71247]
[DOCID:fr17de07-13]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2007-1128; FRL-8507-1]

Approval and Promulgation of Implementation Plans; Nebraska;
Interstate Transport of Pollution

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is revising the Nebraska State Implementation Plan (SIP)
for the purpose of approving the Nebraska Department of Environmental
Quality's (NDEQ) actions to address the ``good neighbor'' provisions of
the Clean Air Act Section 110(a)(2)(D)(i). These provisions require
each state to submit a SIP that prohibits emissions that adversely
affect another State's air quality through interstate transport. NDEQ
has adequately addressed the four distinct elements related to the
impact of interstate transport of air pollutants. These include
prohibiting significant contribution to downwind nonattainment of the
National Ambient Air Quality Standards (NAAQS), interference with
maintenance of the NAAQS, interference with plans in another state to
prevent significant deterioration of air quality, and efforts of other
states to protect visibility. The requirements for public notification
were also met by NDEQ.

DATES: This direct final rule will be effective February 15, 2008,
without further notice, unless EPA receives adverse comment by January
16, 2008. If adverse comment is received, EPA will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-1128, by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Michael Jay, Environmental Protection Agency, Air Planning
and Development Branch, 901 North 5th Street, Kansas City, Kansas
66101.
    4. Hand Delivery or Courier: Deliver your comments to Michael Jay,
Environmental Protection Agency, Air Planning and Development Branch,
901 North 5th Street, Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2007-1128. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov
 or e-mail information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at the Environmental Protection

Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101. The Regional Office's official hours of
business are Monday through Friday, 8 to 4:30 excluding Federal
holidays. The interested persons wanting to examine these documents
should make an appointment with the office at least 24 hours in
advance.

FOR FURTHER INFORMATION CONTACT: Michael Jay at<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This section provides
additional information by addressing the following questions:

What is being addressed in this document?
What action is EPA taking?

What is being addressed in this document?

    EPA is revising the SIP for the purpose of approving the NDEQ's
actions to address the requirements of the Clean Air Act (CAA) section
110(a)(2)(D)(i). This section requires each state to submit a SIP that
prohibits emissions that could adversely affect another state. The SIP
must prevent sources in the state from emitting pollutants in amounts
which will: (1) Contribute significantly to downwind nonattainment of
the NAAQS, (2) interfere with maintenance of the NAAQS, (3) interfere
with provisions to prevent significant deterioration of air quality,
and (4) interfere with efforts to protect visibility.
    EPA issued guidance on August 15, 2006, relating to SIP submissions
to meet the requirements of section 110(a)(2)(D)(i). As discussed
below, Nebraska's analysis of its SIP with respect to the statutory
requirements is consistent with the guidance.
    The NDEQ has addressed the first two of these elements by
submitting a technical demonstration supporting the conclusion that
emissions from

Nebraska do not significantly contribute to downwind nonattainment or
interfere with maintenance of the NAAQS in another state. For
PM2.5, the state has relied upon existing EPA Clean Air
Interstate Rule (CAIR) modeling that determined impacts from the state
do not meet or exceed the 0.2 [mu]g/m\3\ average annual threshold that
EPA established to determine significant impact on another state in the
projection year 2010. The state indicated that in EPA's CAIR modeling,
Nebraska's maximum downwind contribution to average annual
nonattainment was 0.07 [mu]g/m\3\ (70 FR 25247). The state has relied
on this result to demonstrate that emissions from the state do not
contribute significantly to downwind nonattainment of the annual
PM2.5 standard.
    For 8-hour ozone, the state was unable to rely on EPA CAIR modeling
to determine the state's impact on projected 8-hour ozone nonattainment
in downwind states. The EPA CAIR 8-hour ozone modeling domain did not
include the entire state. As a result, impacts from the state were not
provided in the analysis. Therefore, the state has provided additional
analysis, as part of the technical demonstration, to support a
determination that the state does not contribute significantly to
projected downwind 8-hour ozone nonattainment and maintenance in the
year 2010.
    The State's additional analysis includes a modeling demonstration
that supports this conclusion. The modeling demonstration relies on the
source apportionment technique, consistent with the technical analysis
in support of CAIR, to evaluate the State's contribution to nearby
downwind metropolitan statistical areas (MSAs) and nearby counties.
These areas include Chicago and additional counties in Wisconsin along
Lake Michigan, St. Louis, Kansas City, and Denver.
    The determination of significance in the State's analysis was based
upon three contribution factors as determined in CAIR:
     The magnitude of the contribution;
     The frequency of the contribution; and
     The relative amount of contribution.
    The source apportionment modeling analysis yielded consistent
results showing Nebraska does not contribute significantly to downwind
8-hour ozone nonattainment in any of the receptor counties analyzed.
For example, Nebraska's contribution to total nonattainment in Chicago
is 0.36%, with a contribution average of 0.3 ppb, and a 1.74% relative
contribution during exceedance periods. By EPA's own metrics, these
impacts are considered to be small and infrequent. Moreover, not a
single metric of the three contribution factors was found to be above
the significance threshold established by EPA for any of the downwind
counties. (See Technical Support Document for the Final Clean Air
Interstate Rule--Air Quality Modeling). Based on this information
provided by the State, EPA believes the State has sufficiently
demonstrated that emissions from the State do not significantly
contribute to downwind nonattainment or interfere with maintenance of
the NAAQs. Additional supporting information on Nebraska's modeling
demonstration can be found in its technical support document provided
in the docket.
    The third element NDEQ addressed was prevention of significant
deterioration (PSD). For 8-hour ozone, the state has met the obligation
by confirming that major sources in the state are currently subject to
PSD programs that implement the 8-hour ozone standard. For
PM2.5, the state has confirmed that the state's PSD program
is being implemented in accordance with EPA's interim guidance calling
for the use of PM10 as a surrogate for PM2.5 for
the purposes of PSD review. Once PM2.5 guidance is finalized
by EPA, NDEQ commits to transitioning from use of the interim
PM2.5 guidance to the final PM2.5 implementation
guidance after approval of the PM2.5 SIP revision. EPA
proposed regulations to establish this guidance on September 21, 2007
(72 FR 54112).
    It should be noted that Nebraska is currently designated with
attainment for both the 8-hour ozone and PM2.5 National
Ambient Air Quality Standards.
    At this time, it is not possible for NDEQ to accurately determine
whether there is interference with measures in another state's SIP
designed to protect visibility, which is the fourth element that was
addressed. Technical projects relating to visibility degradation are
under development. Nebraska will be in a more advantageous position to
address the visibility projection requirements once the initial
regional haze SIP has been developed.
    A public hearing with regard to this action was held by the state.
No comments were received.
    With this action, the non-regulatory text in 40 CFR 52.1420(e) is
revised to reflect that NDEQ addressed the elements of the CAA section
110(a)(2)(D)(i) submittal.

What action is EPA taking?

    EPA is approving this revision submitted by Nebraska and is
revising 40 CFR 52.1420(e) to reflect that the NDEQ has adequately
addressed the required elements of the CAA section 110(a)(2)(D)(i) SIP.
Please note that if EPA receives adverse comments on part of this rule,
and if that part can be severed from the remainder of the rule, EPA may
adopt as final those parts of the rule that are not the subject of an
adverse comment.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this action will not have
a significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this action approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This action also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the

CAA. This action also is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing state submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the State
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a state submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a state
submission, to use VCS in place of a state submission that otherwise
satisfies the provisions of the CAA. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. This action does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 15, 2008. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

    Dated: November 29, 2007.
William Rice,
Acting Regional Administrator, Region 7.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

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

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

Subpart CC--Nebraska

0
2. In Sec.  52.1420(e) the table is amended by adding an entry in
numerical order to read as follows:

Sec.  52.1420  Identification of Plan.

* * * * *
    (e) * * *

                                 EPA-Approved Nebraska Nonregulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                  Applicable
  Name of nonregulatory SIP      geographic or        State        EPA approval
          provision              nonattainment   submittal date        date                 Explanation
                                     area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(23) CAA 110(a)(2)(D)(i) SIP-- Statewide.......         5/18/07  12/17/07 [insert
 Interstate Transport.                                            FR page number
                                                                  where the
                                                                  document
                                                                  begins].
----------------------------------------------------------------------------------------------------------------

[FR Doc. E7-24231 Filed 12-14-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3186-3188]
[FR Doc No: 2019-01851]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-5052 and FDA-2017-E-5054]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EXONDYS 51

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for EXONDYS 51 and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by April 12, 2019.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 12, 2019. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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 April 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 12, 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 Nos.
FDA-2017-E-5052 and FDA-2017-E-5054 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; EXONDYS 51.'' 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, EXONDYS 51
(eteplirsen) indicated for treatment of Duchenne muscular dystrophy
(DMD) in patients who have a confirmed mutation of the DMD gene that is
amenable to exon 51 skipping. This indication is approved under
accelerated approval based on an increase in dystrophin in skeletal
muscle observed in some patients treated with EXONDYS 51. A clinical
benefit of EXONDYS 51 has not been established. Continued approval for
this indication may be contingent upon verification of a clinical
benefit in confirmatory trials. Subsequent to this approval, the USPTO
received patent term restoration applications for EXONDYS 51 (U.S.
Patent Nos. 7,807,816 and 9,018,368) from the University of Western
Australia and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
October 16, 2017, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
EXONDYS 51 represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EXONDYS 51 is 2,280 days. Of this time, 1,828 days occurred during the
testing phase of the regulatory review period, while 452 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 25, 2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was June 25,
2010.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 26,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for EXONDYS 51 (NDA 206488) was initially submitted
on June 26, 2015.
    3. The date the application was approved: September 19, 2016. FDA
has verified the applicant's claim that NDA 206488 was approved on
September 19, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several

statutory limitations in its calculations of the actual period for
patent extension. In its applications for patent extension, this
applicant seeks 1,314 or 481 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01851 Filed 2-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47834-47835]
[FR Doc No: 2012-19673]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-925-000.
    Applicants: Transcontinental Gas Pipe Line Company,
    Description: Transcontinental Gas Pipe Line Company, LLC submits
tariff filing per 154.204: Transco Market Area Pooling Rate Filing to
be effective 10/1/2012.
    Filed Date: 8/3/12.
    Accession Number: 20120803-5039.
    Comments Due: 5 p.m. ET 8/15/12.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-915-001.

    Applicants: Petal Gas Storage, L.L.C.
    Description: Amendment to RP12-915-000 to be effective 9/1/2012.
    Filed Date: 8/6/12.
    Accession Number: 20120806-5012.
    Comments Due: 5 p.m. ET 8/20/12.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: August 6, 2012.
Nathaniel J. Davis, Sr.
Deputy Secretary
[FR Doc. 2012-19673 Filed 8-9-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Notices]
[Page 2142]
[FR Doc No: 2015-00523]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74021; File No. SR-FINRA-2014-030]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove
Proposed Rule Change Relating to Quotation Requirements for Unlisted
Equity Securities and Deletion of the Rules Related to the OTC Bulletin
Board Service

January 9, 2015.
    On June 27, 2014, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act '' or ``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt rules relating to
quotation requirements for over-the-counter (``OTC'') equity securities
and to delete the rules relating to the OTC Bulletin Board Service
(``OTCBB'') and thus cease its operation. The proposed rule change was
published for comment in the Federal Register on July 15, 2014.\3\ On
August 8, 2014, FINRA consented to extending the time period for the
Commission to either approve or disapprove the proposed rule change, or
to institute proceedings to determine whether to approve or disapprove
the proposed rule change, to October 10, 2014. The Commission received
one comment letter on the proposed rule change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 72575 (July 9,
2014), 79 FR 41339 (``Notice'').
    \4\ See Letter from Daniel Zinn, General Counsel, OTC Markets
Group Inc., dated August 5, 2014 (``OTC Markets Letter'').
---------------------------------------------------------------------------

    On October 7, 2014, the Commission instituted proceedings \5\ to
determine whether to approve or disapprove the proposed rule change
under Section 19(b)(2)(B) of the Act.\6\ The Commission thereafter
received three comment letters in response to the Order Instituting
Proceedings.\7\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 73313, 79 FR 61677
(October 14, 2014) (``Order Instituting Proceedings'').
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Letter from Dr. Lee Jackson, PAHCII, dated October 8,
2014 (``PAHCII Letter''); Letter from Barry Scadden, Vice President,
ATS Trade Support and Operations, Global OTC, dated October 10, 2014
(``Global OTC Letter''); and Letter from Michael R. Trocchio, Sidley
Austin LLP, on behalf of OTC Markets Group Inc., dated November 4,
2014 (``Sidley Letter'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \8\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of the filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for comment in the Federal Register
on July 15, 2014. January 11, 2015 is 180 days from that date, and
March 12, 2015 is an additional 60 days from that date.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change and the issues raised in the comment letters that have been
submitted in connection with the proposal. As the Commission noted in
the Order Instituting Proceedings, the proposal raises questions as to
whether FINRA's proposed rule change is consistent with the
requirements of Sections 15A(b)(6),\9\ 15A(b)(11),\10\ and 17B \11\ of
the Act. Specifically, FINRA's proposal to delete the rules governing
the OTCBB, and thus cease operation of the only self-regulatory
organization (``SRO'') facility that collects, publishes and
distributes quotations in OTC equity securities, raises questions as to
whether the proposal is consistent with the requirements of the Act,
particularly under circumstances where non-SRO quotation systems are
experiencing operational difficulties. In such an event, reliable and
accurate quotation information for OTC equity securities may not be
widely available to investors through such non-SRO systems. Extending
the time within which to approve or disapprove the proposed rule change
will enable the Commission to more fully consider these issues and the
other issues raised in the comment letters.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3(b)(6).
    \10\ 15 U.S.C. 78o-3(b)(11).
    \11\ 15 U.S.C. 78q-2.
---------------------------------------------------------------------------

    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\12\ designates March 12, 2015, as the date by which the Commission
should either approve or disapprove the proposed rule change (File No.
SR-FINRA-2014-030).
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-00523 Filed 1-14-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Rules and Regulations]
[Pages 74298-74301]
[FR Doc No: 2022-26354]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0677; Project Identifier MCAI-2021-01378-T;
Amendment 39-22230; AD 2022-23-03]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier, Inc., Model BD-700-2A12 airplanes. This AD was
prompted by the investigation of erroneous radio altimeter data that
was displayed on an in-service airplane. It was revealed that certain
radio altimeter coaxial cables used by the radio altimeter systems, in
the aft fuselage equipment bay, were damaged. This AD requires
replacing affected radio altimeter coaxial cables. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective January 9, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 9,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0677; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone 1-514-855-2999; email bombardier.com">[email protected]bombardier.com; internet
bombardier.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-0677.

FOR FURTHER INFORMATION CONTACT: Thomas Niczky, Aerospace Engineer,
Avionics and Electrical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Bombardier,
Inc., Model BD-700-2A12 airplanes. The NPRM published in the Federal
Register on June 13, 2022 (87 FR 35686). The NPRM was prompted by AD
CF-2021-45, dated December 7, 2021, issued by Transport Canada Civil
Aviation (TCCA), which is the aviation authority for Canada (referred
to after this as the MCAI). The MCAI states that the erroneous radio
altimeter data was displayed on an in-service airplane. It was revealed
that certain radio altimeter coaxial cables in the aft fuselage
equipment bay had been reported damaged (from radio altimeters A28 and
A29 to antennas), due their light weight construction, and their
proximity to the access door on the eBay. The damage to or kinks in the
radio altimeter coaxial cables, if not corrected, could lead to signal
loss or degradation, and possibly un-annunciated loss of terrain
awareness warning system aural cues during approach.
    In the NPRM, the FAA proposed to require replacing affected radio
altimeter coaxial cables. The FAA is issuing this AD to address the
unsafe condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-0677.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from Netjets. The following presents the
comment received on the NPRM and the FAA's response to the comment.

Request To Refer to Updated Bombardier Service Bulletin

    Netjets stated Bombardier Service Bulletin 700-91-7502, Revision
02, dated April 5, 2022, has been released. The FAA infers that Netjets
is requesting that the proposed AD be revised to refer to Bombardier
Service Bulletin 700-91-7502, Revision 02, dated April 5, 2022 (the
proposed AD refers to Bombardier Service Bulletin 700-91-7502, Revision
01, dated August 31, 2020, as the appropriate source of service
information).
    The FAA agrees with the request. Bombardier Service Bulletin 700-
91-7502, Revision 02, dated April 5, 2022, adds minor changes that do
not affect the substantive requirements proposed in the NPRM, including
adding references to an advisory document and the MCAI AD. The FAA has
revised this final rule to refer to Bombardier Service Bulletin 700-91-
7502, Revision 02, dated April 5, 2022. The FAA has also revised
paragraph (i) of this AD to provide credit for actions done in
accordance with Bombardier Service Bulletin 700-91-7502, Revision 01,
dated August 31, 2020.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comment received, and determined that air safety requires adopting this
AD as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on this product. Except for minor editorial changes,
and any other changes described previously, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Bombardier Service Bulletin 700-91-7502, Revision
02, dated April 5, 2022. This service information specifies procedures
for replacing affected radio altimeter coaxial cables. The replacement
includes removing the existing radio altimeter coaxial cables,
replacing with new coaxial cables, installing new clamps to accommodate
the coaxial bend radius along the coaxial routing, and re-routing new
radio altimeter coaxial cables from the wing to fuselage fairing, in
the left and right aft fuselage, and in the aft fuselage belly fairing.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 27 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
70 work-hours x $85 per hour = $5,950........................         $13,808          $19,758         $533,466
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-23-03 Bombardier, Inc.: Amendment 39-22230; Docket No. FAA-
2022-0677; Project Identifier MCAI-2021-01378-T.

(a) Effective Date

    This airworthiness directive (AD) is effective January 9, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-700-2A12
airplanes, serial numbers 70006 through 70053 inclusive,
certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by the investigation of erroneous radio
altimeter data that was displayed on an in-service airplane. It was
revealed that certain radio altimeter coaxial cables in the aft
fuselage equipment bay were damaged. The FAA is issuing this AD to
address damage to or kinks in the radio altimeter coaxial cables,
which could lead to signal loss or degradation, and possibly un-
annunciated loss of terrain awareness warning system aural cues
during approach.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement of Radio Altimeter Coaxial Cables

    Within 12 months after the effective date of this AD, replace
affected radio altimeter coaxial cables, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 700-91-
7502, Revision 02, dated April 5, 2022, except as specified in
paragraph (h) of this AD.

 (h) No Reporting Requirement

    Although Bombardier Service Bulletin 700-91-7502, Revision 02,
dated April 5, 2022, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using the service information identified in
Bombardier Service Bulletin 700-91-7502, dated February 6, 2020; or
Bombardier Service Bulletin 700-91-7502, Revision 01, dated August
31, 2020.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Additional Information

    (1) Refer to TCCA AD CF-2021-45, dated December 7, 2021, for
related information. This TCCA AD may be found in the AD docket at
regulations.gov under Docket No. FAA-2022-0677.
    (2) For more information about this AD, contact Thomas Niczky,
Aerospace Engineer, Avionics and Electrical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 700-91-7502, Revision 02, dated
April 5, 2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone 1-514-855-2999; email bombardier.com">[email protected]bombardier.com; internet
bombardier.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 27, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-26354 Filed 12-2-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Page 19672]
[FR Doc No: 2012-7756]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0618]

Draft Guidances Relating to the Development of Biosimilar
Products; Public Hearing; Request for Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 2, 2012 (77 FR 12853).
The document announced a public hearing entitled ``Draft Guidances
Related to the Development of Biosimilar Products; Public Hearing;
Request for Comments'' to obtain input on recently issued draft
guidances relating to the development of biosimilar products. The
document published with an incorrect date for submission of electronic
and written comments. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Sandra J. Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5070, appearing on page
12853, in the Federal Register of Friday, March 2, 2012, the following
correction is made:
    On page 12853, in the second column, in the DATES section, the last
sentence is corrected to read: ``Electronic or written comments will be
accepted after the public hearing until May 25, 2012.''

    Dated: March 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7756 Filed 3-30-12; 8:45 am]
BILLING CODE 4160-01-P