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 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 http:// 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 http:// 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