Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys OMB No. 0906-0014-Revised, 42910-42911 [2018-18292]
Download as PDF
<![CDATA[
daltland on DSKBBV9HB2PROD with NOTICES
42910
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
Expert_Consultation_on_Rabies_Postexposure_Prophylaxis.pdf (accessed
January 9, 2017).
39. See https://armypubs.army.mil/
ProductMaps/PubForm/AR_
Details.aspx?ID=0902c85180010355
(accessed May 5, 2017).
40. CDC, ‘‘Cost of Rabies Prevention,’’
updated August 3, 2015; available at
https://www.cdc.gov/rabies/location/
usa/cost.html (accessed February 9,
2017).
41. Gullo, F.P., S.A. Rossi, J.C. Sardi, et al.,
‘‘Cryptococcosis: Epidemiology, Fungal
Resistance, and New Alternatives for
Treatment,’’ European Journal of Clinical
Microbiology and Infectious Diseases,
32:1377–1391, 2013.
42. CDC, ‘‘C. neoformans Infection
Statistics;’’ available at https://
www.cdc.gov/fungal/diseases/
cryptococcosis-neoformans/
statistics.html (accessed August 8, 2016).
43. Makadzange, A.T. and G. McHugh, ‘‘New
Approaches to the Diagnosis and
Treatment of Cryptococcal Meningitis,’’
Seminars in Neurology, 34(1):47–60,
2014.
44. Perfect, J.R., W.E. Dismukes, F. Dromer,
et al., ‘‘Clinical Practice Guidelines for
the Management of Cryptococcal
Disease: 2010 Update by the Infectious
Disease Society of America,’’ Clinical
Infectious Diseases, 50:291–322, 2010.
45. Rothe, C., D.J. Sloan, P. Goodson, et al.,
‘‘A Prospective Longitudinal Study of
the Clinical Outcomes from Cryptococcal
Meningitis Following Treatment
Induction with 800 mg Oral Fluconazole
in Blantyre, Malawi,’’ PLOS One,
8(6):e67311, 2013.
46. Park, B.J., K.A. Wannemuehler, B.J.
Marston, et al., ‘‘Estimation of the
Current Global Burden of Cryptococcal
Meningitis Among Persons Living with
HIV/AIDS,’’ AIDS, 23:525–530, 2009.
47. Mirza, S.A., M. Phelan, D. Rimland, et al.,
‘‘The Changing Epidemiology of
Cryptococcosis: An Update from
Population-Based Active Surveillance in
2 Large Metropolitan Areas, 1992–2000,’’
Clinical Infectious Diseases, 36(6):789–
794, 2003.
48. Pyrgos, V., A.E. Seitz, C.A. Steiner, et al.,
‘‘Epidemiology of Cryptococcal
Meningitis in the US: 1997–2009,’’ PLOS
One, 8(2):e56269, 2013.
49. CDC, ‘‘Emergence of Cryptococcus
gattii—Pacific Northwest, 2004–2010,’’
Morbidity and Mortality Weekly Report,
59(28):865–868, 2010 available at https://
www.cdc.gov/mmwr/preview/
mmwrhtml/mm5928a1.htm?s_
cid=mm5928a1_w.
50. Espinel-Ingroff, A. and S.E. Kidd,
‘‘Current Trends in the Prevalence of
Cryptococcus Gattii in the United States
and Canada,’’ Infection and Drug
Resistance, 8:89–97, May 11, 2015.
51. WHO, ‘‘Rapid Advice: Diagnosis,
Prevention and Management of
Cryptococcal Disease in HIV-Infected
Adults, Adolescents and Children,’’
December 2011; available at https://
www.who.int/hiv/pub/cryptococcal_
disease2011/ (accessed August 8, 2016).
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
52. Joint United Nations Programme on HIV/
AIDS (UNAIDS), ‘‘Global Report:
UNAIDS Report on the Global AIDS
Epidemic 2013;’’ available at https://
files.unaids.org/en/media/unaids/
contentassets/documents/epidemiology/
2013/gr2013/UNAIDS_Global_Report_
2013_en.pdf (accessed August 8, 2016).
Dated: August 21, 2018.
Leslie Kux, Associate Commissioner for
Policy.
[FR Doc. 2018–18314 Filed 8–23–18; 8:45 am]
BILLING CODE 4164–01–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 Secretary’s Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children’s
Public Health System Assessment
Surveys OMB No. 0906–0014—Revised
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of 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. 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 September 24,
2018.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
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
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Secretary’s Discretionary Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
System Assessment Surveys OMB No.
0906–0014—Revised.
ADDRESSES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Abstract: The purpose of the public
health system assessment surveys is to
inform the Secretary’s Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee) on the ability to add
newborn screening for particular
conditions within a state, including the
feasibility, readiness and overall
capacity to screen for a new condition.
The Committee was established under
Section 1111 of the Public Health
Service Act, 42 U.S.C. 300b–10, as
amended in the Newborn Screening
Saves Lives Reauthorization Act of
2014. The Committee is governed by the
provisions of the Federal Advisory
Committee Act, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of advisory
committees. The purpose of the
Committee is to provide the Secretary
with recommendations, advice, and
technical information regarding the
most appropriate application of
technologies, policies, guidelines, and
standards for: (a) Effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders; and (b) enhancing
the ability of state and local health
agencies to provide for newborn and
child screening, counseling, and health
care services for newborns and children
having, or at risk for, heritable
disorders. Specifically, the Committee
makes systematic evidence-based
recommendations on newborn screening
for conditions that have the potential to
change the health outcomes for
newborns.
The Committee tasks an external
workgroup to conduct systematic
evidence-based reviews for conditions
being considered for addition to the
Recommended Uniform Screening
Panel, and their corresponding newborn
screening test(s), confirmatory test(s),
and treatment(s). Reviews also include
an analysis of the benefits and harms of
newborn screening for a selected
condition at a population level and an
assessment of state public health
newborn screening programs’ ability to
implement the screening of a new
condition.
Need and Proposed Use of the
Information: HRSA proposes that the
data collection surveys be administered
by the Committee’s external Evidence
Review Group to all state newborn
screening programs in the United States
up to twice a year for two conditions.
The surveys were developed to capture
the following: (1) The readiness of state
public health newborn screening
programs to expand newborn screening
to include the target condition; (2)
specific requirements of screening for
E:\FR\FM\24AUN1.SGM
24AUN1
42911
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
the condition that could hinder or
facilitate its implementation in each
state; and (3) estimated timeframes
needed for each state to complete major
milestones toward full newborn
screening of the condition.
HRSA published the 60-day notice on
June 5, 2018 (FR Doc. 2018–12019).
There were no comments received
during the 60-day comment period. The
survey tools have been revised to
streamline responses to decrease the
burden on the respondents, provide
clarity with regard to what is being
asked, ensure the survey can
accommodate different types of
conditions that may be nominated in the
future, and offer additional response
options. To accomplish this, questions
were deleted, consolidated, reordered,
and new questions were added to
address gaps in information identified
by those who have completed the
survey and utilized the survey results.
The data gathered will inform the
Committee on the following: (1)
Feasibility of implementing populationbased screening for the target condition;
(2) readiness of state newborn screening
programs to adopt screening for the
condition; (3) identify gaps in feasibility
or readiness to screen for the condition;
and (4) identify areas of technical
assistance and resources needed to
facilitate screening for conditions with
low feasibility or readiness.
Likely Respondents: The respondents
to the survey will be State and territorial
newborn screening programs.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
INITIAL Survey of the Secretary’s Discretionary Advisory
Committee on Heritable Disorders in Newborns and
Children’s Public Health System Assessment .................
FOLLOW-UP Survey of the Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment ..........
59
** 2
118
10.0
1,180
* 30
** 2
60
2.0
120
Total ..............................................................................
89
........................
178
........................
1,300
* Up to 30 States and/or Territories will be asked to complete a follow-up survey.
** Up to two conditions may be reviewed per year. Therefore, there will be two initial surveys and two follow-up surveys per year.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–18292 Filed 8–23–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Nominations for the
Advisory Committee on Training in
Primary Care Medicine and Dentistry
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of request for
nominations.
AGENCY:
HRSA is requesting
nominations to fill vacancies on the
Advisory Committee on Training in
Primary Care Medicine and Dentistry
(ACTPCMD). The ACTPCMD is
authorized by Section 749 of the Public
Health Service (PHS) Act. The Advisory
Committee is governed by provisions of
the Federal Advisory Committee Act
(FACA), as amended, which sets forth
standards for the formation and use of
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:17 Aug 23, 2018
Jkt 244001
advisory committees, and applies to the
extent that the provisions of FACA do
not conflict with the requirements of
PHS Act Section 749.
DATES: HRSA will receive nominations
on a continuous basis.
ADDRESSES: Written nominations for
membership can be submitted by mail
to Advisory Council Operations, Bureau
of Health Workforce, HRSA, Room
11W45C, 5600 Fishers Lane, Rockville,
Maryland 20857 or sent by email to
BHWAdvisoryCouncilFRN@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Kennita R. Carter, MD, Designated
Federal Official, ACTPCMD at 301–945–
3505 or email kcarter@hrsa.gov. A copy
of the current committee membership,
charter, and reports can be obtained by
accessing the ACTPCMD website
https://www.hrsa.gov/advisorycommittees/primarycare-dentist/
index.html.
The
ACTPCMD provides advice and
recommendations to the Secretary of the
Department of Health and Human
Services (Secretary), the Senate
Committee on Health, Education, Labor
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and Pensions, and the House of
Representatives Committee on Energy
and Commerce on matters concerning
policy, program development, and other
matters of significance concerning the
medicine and dentistry activities under
Section 747 of the PHS Act, as it existed
upon the enactment of Section 749 of
the PHS Act in 1998. In addition, the
ACTPCMD develops, publishes, and
implements performance measures and
longitudinal evaluations for programs
under Part C of Title VII of the PHS Act,
as well as recommends appropriation
levels for programs under this part.
Meetings are held twice a year.
Specifically, HRSA is requesting
nominations for voting members of the
ACTPCMD representing allopathic
medicine, osteopathic medicine, family
medicine, general internal medicine,
general pediatrics, physician assistant,
general dentistry, pediatric dentistry,
public health dentistry, dental hygiene,
advanced practice nurse programs, and
other health professionals engaged in
primary care or oral health
interprofessional training. Among these
nominations, students, residents, or
fellows representing allopathic
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42910-42911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18292]
-----------------------------------------------------------------------
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 Secretary's
Discretionary Advisory Committee on Heritable Disorders in Newborns and
Children's Public Health System Assessment Surveys OMB No. 0906-0014--
Revised
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of 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. 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 September
24, 2018.
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 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 Secretary's Discretionary
Advisory Committee on Heritable Disorders in Newborns and Children's
Public Health System Assessment Surveys OMB No. 0906-0014--Revised.
Abstract: The purpose of the public health system assessment
surveys is to inform the Secretary's Discretionary Advisory Committee
on Heritable Disorders in Newborns and Children (Committee) on the
ability to add newborn screening for particular conditions within a
state, including the feasibility, readiness and overall capacity to
screen for a new condition.
The Committee was established under Section 1111 of the Public
Health Service Act, 42 U.S.C. 300b-10, as amended in the Newborn
Screening Saves Lives Reauthorization Act of 2014. The Committee is
governed by the provisions of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), which sets forth standards for the formation
and use of advisory committees. The purpose of the Committee is to
provide the Secretary with recommendations, advice, and technical
information regarding the most appropriate application of technologies,
policies, guidelines, and standards for: (a) Effectively reducing
morbidity and mortality in newborns and children having, or at risk
for, heritable disorders; and (b) enhancing the ability of state and
local health agencies to provide for newborn and child screening,
counseling, and health care services for newborns and children having,
or at risk for, heritable disorders. Specifically, the Committee makes
systematic evidence-based recommendations on newborn screening for
conditions that have the potential to change the health outcomes for
newborns.
The Committee tasks an external workgroup to conduct systematic
evidence-based reviews for conditions being considered for addition to
the Recommended Uniform Screening Panel, and their corresponding
newborn screening test(s), confirmatory test(s), and treatment(s).
Reviews also include an analysis of the benefits and harms of newborn
screening for a selected condition at a population level and an
assessment of state public health newborn screening programs' ability
to implement the screening of a new condition.
Need and Proposed Use of the Information: HRSA proposes that the
data collection surveys be administered by the Committee's external
Evidence Review Group to all state newborn screening programs in the
United States up to twice a year for two conditions. The surveys were
developed to capture the following: (1) The readiness of state public
health newborn screening programs to expand newborn screening to
include the target condition; (2) specific requirements of screening
for
[[Page 42911]]
the condition that could hinder or facilitate its implementation in
each state; and (3) estimated timeframes needed for each state to
complete major milestones toward full newborn screening of the
condition.
HRSA published the 60-day notice on June 5, 2018 (FR Doc. 2018-
12019). There were no comments received during the 60-day comment
period. The survey tools have been revised to streamline responses to
decrease the burden on the respondents, provide clarity with regard to
what is being asked, ensure the survey can accommodate different types
of conditions that may be nominated in the future, and offer additional
response options. To accomplish this, questions were deleted,
consolidated, reordered, and new questions were added to address gaps
in information identified by those who have completed the survey and
utilized the survey results.
The data gathered will inform the Committee on the following: (1)
Feasibility of implementing population-based screening for the target
condition; (2) readiness of state newborn screening programs to adopt
screening for the condition; (3) identify gaps in feasibility or
readiness to screen for the condition; and (4) identify areas of
technical assistance and resources needed to facilitate screening for
conditions with low feasibility or readiness.
Likely Respondents: The respondents to the survey will be State and
territorial newborn screening programs.
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.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
INITIAL Survey of the 59 ** 2 118 10.0 1,180
Secretary's Discretionary
Advisory Committee on Heritable
Disorders in Newborns and
Children's Public Health System
Assessment.....................
FOLLOW-UP Survey of the * 30 ** 2 60 2.0 120
Secretary's Discretionary
Advisory Committee on Heritable
Disorders in Newborns and
Children's Public Health System
Assessment.....................
-------------------------------------------------------------------------------
Total....................... 89 .............. 178 .............. 1,300
----------------------------------------------------------------------------------------------------------------
* Up to 30 States and/or Territories will be asked to complete a follow-up survey.
** Up to two conditions may be reviewed per year. Therefore, there will be two initial surveys and two follow-up
surveys per year.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-18292 Filed 8-23-18; 8:45 am]
BILLING CODE 4165-15-P
