Attachment E - 60-day FRN

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(3) Chondroprotective effects: Pain
intensity in OA is positively associated
with the degree of joint degradation
(Ref. 5). HA has been reported to have
chondroprotective effects by reducing
the degradation and/or restoration of
cartilage (Refs. 11 and 14). According to
the scientific literature, much of the
mechanisms responsible for these
effects are through molecular pathways
(e.g., CD44-initiated pathways) that have
downstream biological effects that act to
alter the disease state of the joint by the
synthesis of extracellular matrix (ECM)
proteins (e.g., collagen type II) and joint
components (e.g., increased
proteoglycan and glycosaminoglycan)
(Refs. 2, 9, 11, and 14). Collectively,
these binding interactions of HA may
act on molecular pathways that serve to
protect and restore cartilage.
Taken together, most of the effects
described above (i.e., anti-inflammatory,
analgesic, and chondroprotective) are
achieved through various molecular
pathways that depend on the direct
interaction of HA with bodily
components (e.g., cellular receptors) and
downstream activation of specific
signaling pathways.
Additionally, although injection of
HA provides mechanical effects (e.g.,
shock absorption), it is believed that
such effects are limited due to the short
half-life of HA (Refs. 2 and 15).
Exogenous-introduced HA has been
reported to have a half-life of a few days
or up to 30 days for cross-linked
versions (Refs. 2 and 15). Nevertheless,
treatment with HA has been reported to
result in clinical therapeutic effect for
up to 6 months following injection (Ref.
9). In other words, treatment with HA
has been reported to continue reduction
in pain long after it is cleared from the
knee joint. This further supports that
HA achieves its primary intended
purpose of the treatment of pain in OA
of the knee through chemical action
within the body (e.g., through its antiinflammatory and chondroprotective
effects that act to mitigate the
underlying OA condition).
Because the current published
scientific literature supports that HA
achieves its primary intended purpose
of the treatment of pain in OA of the
knee through chemical action, and
therefore, HA for this use may not meet
the definition of a device, sponsors of
HA products who intend to submit a
PMA or a supplement to a PMA for a
change in indications for use,
formulation, or route of administration
are encouraged to obtain an informal or
formal classification and jurisdictional
determination through a Pre-RFD or
RFD, respectively, from FDA prior to
submission. If a sponsor believes their

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product meets the device definition,
they may provide relevant evidence in
the pre-RFD or RFD.
II. References
The following references are on
display with the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; these are not
available electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Vasi, A.M., M. Popa, M. Butnaru, et al.,
‘‘Chemical Functionalization of
Hyaluronic Acid for Drug Delivery
Applications.’’ Materials Science and
Engineering, 38: 177–185, 2014.
2. Altman, R.D., V. Dasa, and J. Takeuchi,
‘‘Review of the Mechanism of Action for
Supartz FX in Knee Osteoarthritis.’’
Cartilage, 9: 11–20, 2018. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC5724672/
3. Greenberg, D.D., A. Stoker, S. Kane, et al.,
‘‘Biochemical Effects of Two Different
Hyaluronic Acid Products in a CoCulture Model of Osteoarthritis.’’
OsteoArthritis and Cartilage, 14: 814–
822, 2006. https://
www.sciencedirect.com/science/article/
pii/S1063458406000367?via%3Dihub
4. Jahn, S., J. Seror, and J. Klein, ‘‘Lubrication
of Articular Cartilage.’’ Annual Review of
Biomedical Engineering, 18: 235–258,
2016.
5. Trouvin, A.-P. and S. Perrot, ‘‘Pain in
Osteoarthritis. Implications for Optimal
Management.’’ Joint Bone Spine, 85:
429–434, 2018.
6. Balazs, E.A., ‘‘The Physical Properties of
Synovial Fluid and the Special Role of
Hyaluronic Acid.’’ In Disorders of the
Knee, A. Helfet, pp. 63–75. Philadelphia:
Lippincott Company, 1974.
7. Liao, Y.-H, S.A. Jones, B. Forbes, et al.,
‘‘Hyaluronan: Pharmaceutical
Characterization and Drug Delivery.’’
Drug Delivery, 12: 327–342, 2005.
https://www.tandfonline.com/doi/full/
10.1080/10717540590952555%20
8. Moreland, L.W. ‘‘Intra-Articular
Hyaluronan (hyaluronic acid) and
Hylans for the Treatment of
Osteoarthritis: Mechanisms of Action.’’
Arthritis Research and Therapy, 5: 54–
67, 2003. https://www.ncbi.nlm.nih.gov/
pmc/articles/PMC165033/
9. Altman, R.D., A. Manjoo, A. Fierlinger, et
al., ‘‘The Mechanism of Action for
Hyaluronic Acid Treatment in the
Osteoarthritic Knee: A Systematic
Review.’’ BMC Musculoskeletal
Disorders, 16: 321, 2015. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC4621876/

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10. Richards, M., J. Maxwell, L. Weng, et al.,
‘‘Intra-Articular Treatment of Knee
Osteoarthritis: From Anti-inflammatories
to Products of Regenerative Medicine.’’
The Physician and Sportsmedicine, 44:
101–108, 2016. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC4932822/
11. Nicholls, M., A. Fierlinger, F. Zaizi, et al.,
‘‘The Disease Modifying Effects of
Hyaluronan in the Osteoarthritic Disease
State.’’ Clinical Medicine Insights:
Arthritis and Musculoskeletal Disorders,
10: 1–10, 2017. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC5555499/
12. Migliore, A. and S. Procopio,
‘‘Effectiveness and Utility of Hyaluronic
Acid in Osteoarthritis.’’ Clinical Cases in
Mineral and Bone Metabolism, 12: 31–
33, 2015. https://www.ncbi.nlm.nih.gov/
pmc/articles/PMC4469223/
13. Schaible, H.-G., F. Richter, A. Ebersberge,
et al., ‘‘Joint Pain.’’ Experimental Brain
Research, 196: 153–162, 2009.
14. Chen, L., J. Xue, Z. Zheng, et al.,
‘‘Hyaluronic Acid, an Efficient
Biomacromolecule for Treatment of
Inflammatory Skin and Joint Diseases: A
Review of Recent Developments and
Critical Appraisal of Preclinical and
Clinical Investigations.’’ International
Journal of Biological Macromolecules,
116: 572–584, 2018.
15. Strauss, E., J. Hart, M. Miller, et al.,
‘‘Hyaluronic Acid Viscosupplementation
and Osteoarthritis: Current Uses and
Future Directions.’’ The American
Journal of Sports Medicine, 37: 1636–
1644, 2009.
Dated: December 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27351 Filed 12–17–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: HRSA AIDS
Education and Training Centers
Evaluation Activities, OMB No. 0915–
0281—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the

SUMMARY:

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Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 19,
2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, pursuant to Section
3506(c)(2)(A), the Paperwork Reduction
Act of 1995.
Information Collection Request Title:
HRSA Ryan White HIV/AIDS Program
(RWHAP) AIDS Education and Training
Centers (AETC) Evaluation Activities,
OMB No. 0915–0281—Revision
Abstract: The RWHAP AETC
program, authorized by Title XXVI of
the Public Health Service Act, supports
a network of regional and national
centers that conduct targeted, multidisciplinary education and training
programs for health care providers
serving people living with HIV (PLWH).
The purpose of the RWHAP Regional
AETC program is to increase the size
and strengthen the skills of the current
and novice HIV clinical workforce in
the United States. Through the
provision of specialized professional
education and training, the RWHAP
Regional AETCs aim to improve
outcomes along the HIV care continuum
including diagnosis, linkage, retention,
and viral suppression and to reduce HIV
incidence by improving the
achievement and maintenance of viral
load suppression of PLWH. In addition,

the RWHAP AETC program includes the
National Coordinating Resource Center
(NCRC), which offers a virtual library of
online training resources for adaptation
by HIV care providers and other
healthcare professionals to meet local
training needs. The RWHAP AETC
NCRC works closely with the HRSA
HIV/AIDS Bureau (HAB) to coordinate
cross-regional collaborative efforts,
manage the NCRC website, plan and
execute the national RWHAP Clinical
Conference, and develop an online
curriculum for clinical learners.
The RWHAP AETC proposes several
revisions to the Event Records (ER) and
the Participant Information Form (PIF).
The ER will have nine new data
elements; however, only five data
elements will require responses from all
respondents. The option to respond to
the other four data elements will
depend on how participants respond to
previous questions. The PIF will have
one new data element that asks whether
respondents prescribe anti-retroviral
therapy to their patients. Three data
elements were also deleted. These
revisions reflect changes in the National
AETC program guidance on reporting
sources of funding and multi-session
events. With a net increase of seven data
elements across both the ER and PIF
instruments, respondent burden is
anticipated to increase slightly. In
addition, HRSA HAB has modified the
data instruments not only to improve
the logical flow of questions within each
instrument but also to improve the
overall clarity of each of the questions
being asked.
Need and Proposed Use of the
Information: As part of an ongoing effort
to evaluate RWHAP AETC activities,
information is needed on AETC training
sessions, clinical consultations, and
technical assistance activities. Each
regional center collects information on
RWHAP AETC training events and is
required to report aggregate data on
their activities to HRSA’s HAB. The goal
of national data collection efforts is to
create a uniform set of data elements
that will produce an accurate summary
of the national scope of RWHAP AETC
professional training, consultation, and

events. The elements included in the
national database have been selected for
their relevance in demonstrating the
RWHAP AETCs’ efforts in achieving the
program’s stated goals: To improve care
for PLWH by providing education,
training, and clinical consultation; and
to provide support to clinicians and
other providers. HRSA HAB uses the
data collected when conducting
programmatic assessments and to
determine future program needs. The
national data elements are intended to
be a meaningful core set of elements
that individual RWHAP AETCs can use
in program and strategic planning.
HRSA HAB also uses this information to
respond to requests from HHS,
Congress, and others.
Likely Respondents: RWHAP AETC
trainees are asked to complete the PIF
at the start or conclusion of an event.
Trainers are asked to complete an ER for
each training event they conduct during
the year. In addition, each regional
RWHAP AETC (eight total) and the
RWHAP AETC National Coordinating
Resource Center will compile these data
into a data set and submit to HRSA HAB
once a year.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. 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. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The estimated annual response
burden to trainers, as well as trainees of
training programs is follows:

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

amozie on DSK3GDR082PROD with NOTICES

Form name

Number of
responses per
respondent

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Participant Information Form (PIF) ......................................
Event Record (ER) ...............................................................

61,288
10,522

1
1

61,288
10,522

0.167
0.200

10,235
2,104

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

71,810

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

71,810

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

12,339

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64847

The estimated annual burden to
RWHAP AETCs is as follows:
Number of
respondents

Responses per
respondent

Total
responses

Hours per
response

Total burden
hours

9

2

18

32

576

Aggregate Data Set .............................................................

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.

In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. A 60-day Federal
Register Notice was published in the
Federal Register on February 21, 2018.
There were 24 public comments.
Comments submitted during the first
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
DATES: Comments on this ICR should be
received no later than January 17, 2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk

officer for HRSA, either by email to
[email protected] or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
[email protected] or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Quarterly Data Collection, OMB
Number: 0906–0016—Revision.
Abstract: This clearance request is for
continued approval of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program Quarterly
Data Collection. The MIECHV Program,
administered by HRSA in partnership
with the Administration for Children
and Families (ACF), supports voluntary,
evidence-based home visiting services
during pregnancy and to parents with
young children up to kindergarten
entry. States, certain non-profit
organizations, and Tribal entities are
eligible to receive funding from the
MIECHV Program and have the
flexibility to tailor the program to serve
the specific needs of their communities.
After taking into consideration public
comments in response to the 60-day
notice published in the Federal Register
on February 21, 2018 (83 FR 7481),
HRSA is proposing revisions to the data
collection forms for the MIECHV
Program by making the following
changes:
• Form 4, Due date: The due date will
be revised from 60 days to 30 days after
the end of each reporting period.
• Form 4, Section A: All tables will be
renumbered.
• Form 4, Table A.2: Columns will be
revised to reflect Local Implementing
Agencies (LIAs) served, LIA addresses,
counties served, zip codes served, and
evidence-based home visiting models
implemented.
• Form 4, Table A.4.1: Columns will
be combined to reflect number of fulltime equivalents (FTEs) for home
visitors, supervisors, and other staff.

1 HRSA currently estimates approximately 10
awardees may need to report benchmark

performance data on a quarterly basis based on the
statutorily-required assessment of improvement.

Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–27328 Filed 12–17–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The Maternal, Infant, and
Early Childhood Home Visiting
Program Quarterly Data Collection,
OMB No. 0906–0016—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

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SUMMARY:

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• Form 4, Table A.4.2: Table will be
deleted.
• Form 4, Section B: Section will be
updated to reflect current benchmark
constructs.
• Form 4, Definitions of Key Terms:
Update definitions for all tables. HRSA
is requesting approval of this revised
information collection request through
March 31, 2022.
Need and Proposed Use of the
Information: HRSA uses quarterly
performance information to demonstrate
program accountability and
continuously monitor and provide
oversight to MIECHV Program awardees.
The information is also used to provide
quality improvement guidance and
technical assistance to awardees and
help inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
revise place-based services and staffing
indicators for home visiting programs.
In addition, on a quarterly basis HRSA
will collect a set of standardized
performance and outcome indicators
that correspond with the benchmark
areas identified in statute for awardees
who fail to demonstrate improvement
through the required 3-year assessment
of improvement.
Likely Respondents: MIECHV Program
awardees (n=56).
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. 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. The total annual burden
hours estimated for this ICR are
summarized in the table below:
2 The 10 responses for Section B are a sub-set of
56 total awardees funded through the MIECHV
Program.

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