Att 2_60dy FRN

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Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents

Burmese Refugees ...........................

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

1
1
1
1
1

5/60
5/60
5/60
40/60
35/60

11
4
3
22
19

33
33

1
1

5/60
5/60

3
3

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

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

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

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

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BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[60Day-17–17IV; Docket No. ATSDR–2016–
0008]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Agency for Toxic
Substances and Disease Registry
(ATSDR), as part of its continuing
efforts to reduce public burden and
maximize the utility of government
information, invites the general public
and other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. This
notice invites comment on the
information collection request titled
‘‘APPLETREE Performance Measures.’’
Under the APPLETREE cooperative
agreement program (Funding
Opportunity Announcement No. CDC–
RFA–TS17–1701), awardees will be
required to submit an Annual Plan of
Work (APOW), several standardized
outcome and performance measures,
and an Annual Performance Report
(APR).

SUMMARY:

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Total burden
(in hours)

133
42
33
33
33

[FR Doc. 2016–31772 Filed 12–30–16; 8:45 am]

22:14 Dec 30, 2016

Average
burden per
response
(in hours)

Follow-up Survey .............................
Eligibility Screening Survey ..............
Contact Information Form ................
Study Questionnaire .........................
Clinic Visit Checklist and Body
Measurements.
Network Size Questions ...................
Follow-up Survey .............................

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

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Number of
responses per
respondent

Number of
respondents

Form name

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Written comments must be
received on or before March 6, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2016–
0008 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted through the
Federal eRulemaking portal
(Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
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
DATES:

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previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. 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; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
APPLETREE Performance Measures—
New—Agency for Toxic Substances and
Disease Registry (ATSDR).

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127

Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
Background and Brief Description
The Agency for Toxic Substances and
Disease Registry (ATSDR) serves the
public through responsive public health
actions to promote healthy and safe
environments and to prevent harmful
exposures in communities across the
nation. ATSDR’s Partnership to Promote
Local Efforts to Reduce Environmental
Exposure (APPLETREE) Program is
critical to ATSDR’s success in this
mission. The purpose of the program is
to: (1) Identify pathways of exposure to
hazardous substances at hazardous
waste sites and releases; (2) identify,
implement, and coordinate public
health interventions to reduce
exposures to hazardous substances
which occur at levels of health concern;
and (3) provide training at the state level
to promote and achieve the safe siting
of child care facilities in the United
States. The APPLETREE Program is also
a mechanism which enhances ATSDR’s
communication with state, local, and
federal health and environmental
agencies. This program is authorized
under Sections 104(i)(15) of the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended by
the Superfund Amendments and
Reauthorization Act (SARA) of 1986 [42
U.S.C. 9604(i)(15)].
Under the new three-year
APPLETREE cooperative agreement
(Funding Opportunity Announcement
No. CDC–RFA–TS17–1701), eligible
applicants include federally recognized
American Indian/Alaska Native tribal
governments; American Indian/Alaska
native tribally designated organizations;
political subdivisions of states (in
consultation with states); and state and
local governments or their bona fide
agents. ATSDR technical project officers
(TPOs) will assist approximately 25
APPLETREE awardees to address sitespecific issues involving human
exposure to hazardous substances. Key
capacities include identification of

will enter an average of 37 activities into
the HEAT database.
ATSDR Site Impact Assessment (SIA)
Performance Measure: For each
environmental health assessment and
health education activity conducted at
ATSDR sites, awardees shall estimate
and report the number of people
protected from exposure to toxic
substances at each site where
implementation of agency
recommendations has taken place and at
each child care center where safe siting
guidelines have been implemented. To
the extent possible, awardees shall
estimate the disease burden prevented
due to the implementation of site
recommendations and safe siting
guidelines. This information will be
entered into the ATSDR SIA database by
the awardee. ATSDR assumes a
maximum of 150 ATSDR sites will
undergo an environmental assessment,
or an average of 6 sites per awardee, per
year.
APPLETREE Annual Performance
Report (APR): Awardees must provide
an APR at the end of each budget year.
The report must include a minimum of
three site activity success stories; a
synopsis of the number of people
involved in environmental health
assessments at sites, the number of
public health recommendations
accepted, the number of health
education activities conducted at sites;
and the outcomes achieved during the
budget year. The APR must also
demonstrate annual progress in
implementing child care safe siting
policies in their jurisdictions over the
three-year program period. ATSDR
assumes that ASARs will take 15 burden
hours for each awardee to prepare.
ATSDR seeks to request a three-year
clearance from OMB to collect the
necessary information for this project.
The awardee reporting is a
requirement of the APPLETREE
cooperative agreement. The total annual
time burden requested is 635 hours.

human exposure pathways at ATSDR
sites, education of affected communities
and local health professionals about site
contamination and potential health
effects; making appropriate
recommendations to prevent exposure;
reviewing health outcome data to
evaluate potential links between site
contaminants and community health;
and documenting the effects of
environmental remediation on health.
ATSDR will collect information
related to awardee activities, and the
process and outcome performance
measures outlined by the cooperative
agreement program. Information will be
used to monitor progress toward
program goals and objectives, and for
quality improvement.
Annual Plan of Work (APOW): Each
budget year, awardees shall deliver an
APOW. The APOW will include
awardee workplans for site-specific
activities, environmental health
assessment outputs, and overarching
milestones for child care safe siting
activities. The estimated annual time
burden to prepare and report the APOW
is eight hours per awardee.
ATSDR Health Education Activity
Tracking (HEAT) Performance Measure:
For each environmental health
assessment and health education
activity conducted at ATSDR sites,
APPLETREE awardees shall
quantitatively assess and report efforts
to educate community members about
site recommendations and health risks
using indicators to assess community
understanding of site findings about
health risks and community
understanding of agency
recommendations to reduce health risks.
This information will be entered in to
the ATSDR HEAT system for each
activity at ATSDR sites. Based on past
experience, ATSDR assumes a
maximum of 925 activities will be
entered into the HEAT database each
year; therefore, each of the 25 awardees

sradovich on DSK3GMQ082PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
per year

Number of
responses per
respondent
per year

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

APPLETREE Awardees ....................

Annual Plan of Work (APOW) .........
ATSDR Health Education Activity
Tracking (HEAT) Form.
ATSDR Site Impact Assessment
(SIA) Form.
APPLETREE Annual Performance
Report (APR).

25
25

1
37

8
3/60

200
47

25

6

5/60

13

25

1

15

375

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

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

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

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

635

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

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Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–31773 Filed 12–30–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4436]

Premarket Notification (510(k))
Submissions for Bone Anchors; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Premarket
Notification (510(k)) Submissions for
Bone Anchors.’’ The guidance provides
recommendations for the information
and testing that should be included in
premarket submissions for bone anchor
(suture anchor) devices used in the
appendicular skeleton for attachment of
soft tissue to bone. This draft guidance
is not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 6, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:

sradovich on DSK3GMQ082PROD with NOTICES

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

VerDate Sep<11>2014

22:14 Dec 30, 2016

Jkt 241001

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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–4436 for ‘‘Premarket
Notification (510(k)) Submissions for
Bone Anchors.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in

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accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: http://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Premarket
Notification (510(k)) Submissions for
Bone Anchors’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Daniel Ramsey, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1451, Silver Spring,
MD 20993–0002, 301–796–6451.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ’’’Premarket Notification
(510(k)) Submissions for Bone
Anchors.’’ FDA has developed this
guidance document for members of
industry who submit and FDA staff who
review premarket submissions regarding
bone anchor (suture anchor) devices
used in the appendicular skeleton for
attachment of soft tissue to bone. When
finalized, this guidance is intended to
provide recommendations for
information to include in premarket
notifications (510(k)) for bone anchor
(suture anchor) devices (e.g., descriptive
characteristics, labeling,
biocompatibility, sterility, and bench
testing). This guidance is a reissuance of
the April 20, 1996 ‘‘Guidance Document
for Testing Bone Anchor Devices’’ with
updated content.

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