60 Day FRN

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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
health outcomes, including opioid
overdose, sexual assault, and suicide
attempts. The nature and consequences
of ACEs in Tribal communities is
unique because of historical trauma and
stark socioeconomic disparities. In
addition, there are gaps in the provision
of adequate healthcare.
This collection addresses critical
research gaps and extends efforts to
prevent violence and other ACEs before
they occur and to build evidence of
effectiveness of community-level
strategies and approaches at the outer
levels of the social ecology to Tribal
communities. Results from this data

(three urban and three rural) in regions
identified with higher opioid overdose
mortality rates relatively to other areas
in Indian Country. Due to COVID–19, at
the time of the focus groups/interviews,
social distancing and public health
safety measures will be implemented,
including considerations for phone/
virtual meetings instead of in-person
sessions.
The total estimated annualized
burden hours are 918. There are no costs
to respondents other than their time.

collection will be communicated to
relevant public health officials and
community stakeholders in the study
locations. These local public health
officials and community stakeholders
will use the study results to guide
strategies to further strengthen their
local prevention efforts within their
regions.
Data collection methods used in this
study include well-established
qualitative methods, including in-depth
open-ended individual interviews and
focus groups. Quantitative methods
include brief structured surveys. There
will be a total of six Tribal communities

ESTIMATED ANNUALIZED BURDEN HOURS

Adults 18 years or older affected by the
opioid epidemic living in Tribal urban and
rural communities.

Information Letter .................
Telephone screening ............
Confirmation email/letter .......
Reminder email ....................
Informed Consent .................
Survey ...................................
Focus group/interview ..........

336
336
252
252
252
252
252

1
1
1
1
1
1
1

5/60
20/60
3/60
2/60
15/60
45/60
2

28
112
13
9
63
189
504

Total ................................................

...............................................

........................

........................

........................

918

[FR Doc. 2020–14331 Filed 7–1–20; 8:45 am]
BILLING CODE 4163–20–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

proposed information collection project
titled Oral Health Basic Screening
Survey for Children. The project
provides state-specific data on dental
caries (tooth decay) and dental sealants
from a state-representative sample of
elementary school children or children
enrolled in Head Start programs and has
been used by states to monitor oral
health status of children and evaluate
public health programs and policies.

Centers for Disease Control and
Prevention

DATES:

[60Day–20–20PM; Docket No. CDC–2020–
0072]

ADDRESSES:

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a

SUMMARY:

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Average
burden per
response
(in hours)

Data collection

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

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21:18 Jul 01, 2020

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Number of
respondents

Number of
responses per
respondent

Type of
respondents

CDC must receive written
comments on or before August 31, 2020.
You may submit comments,
identified by Docket No. CDC–2020–
0072 by any of the following methods:
• Federal eRulemaking Portal: http://
www.Regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to http://
www.regulations.gov/.

Please note: Submit all comments through
the Federal eRulemaking portal (http://
www.regulations.gov) or by U.S. mail to the
address listed above.

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Total burden
(in hours)

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
FOR FURTHER INFORMATION CONTACT:

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39912

Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices

functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Oral Health Basic Screening Survey for
Children—Existing Collection in Use
Without an OMB Control Number—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC)
Background and Brief Description
Dental caries (tooth decay) is one of
the most common chronic diseases
among children in the United States and
can lead to pain, infection, and
diminished quality of life throughout
the lifespan. Dental sealants are a costeffective measure to prevent caries but
remain underutilized.
To address states’ critical need for
state-level oral health surveillance data
on dental caries and sealants, the
Association of State and Territorial
Dental Directors (ASTDD) developed
and released an oral health screening
survey protocol referred to as the Basic
Screening Survey (BSS) in 1999 in
collaboration with the Ohio Department
of Health and with technical assistance
from the CDC’s Division of Oral Health.

states currently funded by CDC, will
conduct one BSS, at least for third
grade, during the period for which this
approval is being sought.
State health departments administer
the survey by determining probability
samples, arranging logistics with
selected schools or Head Start sites,
gaining consent, obtaining demographic
data, training screeners, conducting the
oral health screening at schools or Head
Start sites. Screeners record four data
points either electronically or on a
paper form: (1) Presence of treated
caries, (2) presence of untreated tooth
decay, (3) urgency of need for treatment,
and (4) presence of dental sealants on at
least one permanent molar tooth.
State programs enter, clean and
analyze the data; de-identify it; and
respond to ASTDD’s annual email
request for state-aggregated prevalence
of dental caries and sealants. ASTDD
reviews the data to ensure that both
survey design and data meet specific
criteria before sending it to CDC for
publication on the CDC’s public-facing
Oral Health Data website (http://
www.cdc.gov/oralhealthdata).
BSS for children serves as a key state
oral health surveillance data source and
facilitates state capacity to (1) monitor
children’s oral health status, trends, and
disparities, and compare with other
states; (2) inform planning,
implementation and evaluation of
effective oral health programs and
policies; (3) measure state progress
toward Healthy People objectives; and
(4) educate the public and policy
makers regarding cross-cutting public
health programs. CDC also uses the data
to evaluate performance of CDC oral
health funding recipients.
There are no costs to children
respondents except their time. The
estimated total annualized burden hours
for the survey across the 34 states over
the three years of this request are 40,207
with an average of 1,183 per state.

BSS is a non-invasive visual
observation of the mouth performed by
trained screeners including dental and
non-dental health professionals (e.g.,
dentists, hygienists, school nurses). The
BSS data collection is not duplicative of
any other federal collection. Though the
National Health and Nutrition
Examination Survey (NHANES) collects
national data on oral health status
including dental caries and sealants
based on clinical examination, it is not
designed to provide state-level data.
BSS is designed to be easy to perform,
while being consistent and aligned with
the oral health Healthy People
objectives, which are based on NHANES
measures. BSS is the only data source
that provides state-representative data
on oral health status based on clinical
examination. BSS is also used to
monitor state progress toward key
national oral health objectives.
The BSS is a state-tailored survey
administered and conducted by
individual states. CDC has supported
some of the 50 states to build and
maintain their oral health surveillance
system and ASTDD to provide technical
assistance to states through state and
partner cooperative agreements since
2001. Conducting BSS for third graders
is a key component of that support.
The target populations include school
children in grades K–3 and children
enrolled in Head Start in 50 states and
Washington, DC. ASTDD and CDC
recommend that states conduct BSS at
minimum for third graders at least once
every five years. Individual states
determine how often to conduct BSS
and which grade or grades to target
based on their program needs and
available resources. Forty-seven states
have conducted BSS for children, and
all 47 conducted third grade BSS.
Thirty-two states also have conducted
BSS in one or more other grades (K–2)
or in Head Start. CDC estimates that
approximately 34 states, including 20

khammond on DSKJM1Z7X2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

Child ..................................................
Parent/caretaker ................................
Screener ............................................
School/site .........................................
State Official ......................................

Screening form .................................
Consent ............................................
Screening form .................................
Participation form .............................
Data Submission form ......................

150,370
150,370
301
2,890
34

1
1
1
1
1

5/60
1/60
666/60
68/60
32,742/60

12,531
2,506
3,341
3,275
18,554

Total ...........................................

...........................................................

........................

........................

........................

40,207

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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–14332 Filed 7–1–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1360]

Teva Branded Pharmaceutical
Products R&D, Inc.; Withdrawal of
Approval of a New Drug Application for
ZECUITY (Sumatriptan Iontophoretic
Transdermal System)
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is withdrawing
the approval of the new drug
application (NDA) for ZECUITY
(sumatriptan iontophoretic transdermal
system) held by Teva Branded
Pharmaceutical Products R&D, Inc.
(Teva), 41 Moores Rd., P.O. Box 4011,
Frazer, PA 19355. Teva requested
withdrawal of this application and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of July
2, 2020.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg., 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: On
January 17, 2013, FDA approved NDA
202278 for ZECUITY (sumatriptan
iontophoretic transdermal system) for
the acute treatment of migraine with or
without aura in adults. On June 2, 2016,
FDA issued a Drug Safety
Communication announcing the FDA is
investigating the risk of serious burns
and potential permanent scarring with
the use of ZECUITY for migraine
headaches. (https://www.fda.gov/drugs/
drug-safety-and-availability/fda-drugsafety-communication-fda-evaluatingrisk-burns-and-scars-ZECUITYsumatriptan-migraine-patch). On June
10, 2016, Teva suspended sales,
marketing and distribution to
investigate the cause of burns and scars
associated with ZECUITY.
On July 19, 2019, Teva requested
withdrawal of NDA 202278 for
ZECUITY under § 314.150(d) (21 CFR
314.150(d)) and waived its opportunity
for a hearing. In its letter requesting

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SUMMARY:

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Jkt 250001

withdrawal of approval, Teva stated that
it voluntarily discontinued manufacture
and sale of products under NDA 202278
in 2016 for commercial reasons and has
agreed to withdrawal of the application
for those reasons only.
For the reasons discussed above, and
pursuant to the applicant’s request,
approval of NDA 202278 for ZECUITY
(sumatriptan iontophoretic transdermal
system), and all amendments and
supplements thereto, is withdrawn
under § 314.150(d).
Distribution of ZECUITY into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14284 Filed 7–1–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Radioactive Drug
Research Committees
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by August 3,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0053. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:

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39913

Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:

Radioactive Drug Research
Committees—21 CFR 361.1
OMB Control Number 0910–0053—
Extension
Under sections 201, 505, and 701 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321, 355, and 371), FDA
has the authority to issue regulations
governing the use of radioactive drugs
for basic scientific research. This
information collection request supports
those regulations. Specifically, § 361.1
(21 CFR 361.1) sets forth specific
regulations about establishing and
composing radioactive drug research
committees (RDRCs) and their role in
approving and monitoring basic
research studies using
radiopharmaceuticals. No basic research
study involving any administration of a
radioactive drug to research subjects is
permitted without the authorization of
an FDA-approved RDRC (§ 361.1(d)(7)).
The type of research that may be
undertaken with a radiopharmaceutical
drug must be intended to obtain basic
information and not to carry out a
clinical trial for safety or efficacy. The
types of basic research permitted are
specified in the regulations and include
studies of metabolism, human
physiology, pathophysiology, or
biochemistry.
Section 361.1(c)(2) requires that each
RDRC will select a chairman, who will
sign all applications, minutes, and
reports of the committee. Each
committee will meet at least once each
quarter in which research activity has
been authorized or conducted. Minutes
will be kept and will include the
numerical results of votes on protocols
involving use in human subjects. Under
§ 361.1(c)(3), each RDRC will submit an
annual report to FDA. The annual report
will include the names and
qualifications of the members of and of
any consultants used by the RDRC,
using Form FDA 2914 entitled
‘‘Radioactive Drug Research Committee
Report on Research Use of Radioactive
Drugs Membership Summary.’’ The
annual report will also include a
summary of each study conducted
during the preceding year, using Form

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