83 FR 42910 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 165 (August 24, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 165 (August 24, 2018)
| Page Range | 42910-42911 | |
| FR Document | 2018-18292 |
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)] [Notices] [Pages 42910-42911] From the Federal Register Online [www.thefederalregister.org] [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
![42910 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
Expert_Consultation_on_Rabies_Post- 52. Joint United Nations Programme on HIV/ Abstract: The purpose of the public
exposure_Prophylaxis.pdf (accessed AIDS (UNAIDS), ‘‘Global Report: health system assessment surveys is to
January 9, 2017). UNAIDS Report on the Global AIDS inform the Secretary’s Discretionary
39. See https://armypubs.army.mil/ Epidemic 2013;’’ available at http:// Advisory Committee on Heritable
ProductMaps/PubForm/AR_ files.unaids.org/en/media/unaids/
Details.aspx?ID=0902c85180010355 contentassets/documents/epidemiology/
Disorders in Newborns and Children
(accessed May 5, 2017). 2013/gr2013/UNAIDS_Global_Report_ (Committee) on the ability to add
40. CDC, ‘‘Cost of Rabies Prevention,’’ 2013_en.pdf (accessed August 8, 2016). newborn screening for particular
updated August 3, 2015; available at conditions within a state, including the
Dated: August 21, 2018.
https://www.cdc.gov/rabies/location/ feasibility, readiness and overall
usa/cost.html (accessed February 9, Leslie Kux, Associate Commissioner for capacity to screen for a new condition.
2017). Policy. The Committee was established under
41. Gullo, F.P., S.A. Rossi, J.C. Sardi, et al., [FR Doc. 2018–18314 Filed 8–23–18; 8:45 am] Section 1111 of the Public Health
‘‘Cryptococcosis: Epidemiology, Fungal BILLING CODE 4164–01–P Service Act, 42 U.S.C. 300b–10, as
Resistance, and New Alternatives for
Treatment,’’ European Journal of Clinical
amended in the Newborn Screening
Microbiology and Infectious Diseases, Saves Lives Reauthorization Act of
DEPARTMENT OF HEALTH AND 2014. The Committee is governed by the
32:1377–1391, 2013.
42. CDC, ‘‘C. neoformans Infection HUMAN SERVICES provisions of the Federal Advisory
Statistics;’’ available at https:// Committee Act, as amended (5 U.S.C.
www.cdc.gov/fungal/diseases/ Health Resources and Services App.), which sets forth standards for the
cryptococcosis-neoformans/ Administration formation and use of advisory
statistics.html (accessed August 8, 2016). committees. The purpose of the
43. Makadzange, A.T. and G. McHugh, ‘‘New Agency Information Collection
Activities: Submission to OMB for Committee is to provide the Secretary
Approaches to the Diagnosis and
Review and Approval; Public Comment with recommendations, advice, and
Treatment of Cryptococcal Meningitis,’’
Seminars in Neurology, 34(1):47–60, Request; The Secretary’s Discretionary technical information regarding the
2014. Advisory Committee on Heritable most appropriate application of
44. Perfect, J.R., W.E. Dismukes, F. Dromer, technologies, policies, guidelines, and
Disorders in Newborns and Children’s
et al., ‘‘Clinical Practice Guidelines for standards for: (a) Effectively reducing
Public Health System Assessment
the Management of Cryptococcal morbidity and mortality in newborns
Surveys OMB No. 0906–0014—Revised
Disease: 2010 Update by the Infectious and children having, or at risk for,
Disease Society of America,’’ Clinical AGENCY: Health Resources and Services heritable disorders; and (b) enhancing
Infectious Diseases, 50:291–322, 2010. the ability of state and local health
Administration (HRSA), Department of
45. Rothe, C., D.J. Sloan, P. Goodson, et al., agencies to provide for newborn and
‘‘A Prospective Longitudinal Study of Health and Human Services.
child screening, counseling, and health
the Clinical Outcomes from Cryptococcal ACTION: Notice.
Meningitis Following Treatment care services for newborns and children
Induction with 800 mg Oral Fluconazole SUMMARY: In compliance with of the having, or at risk for, heritable
in Blantyre, Malawi,’’ PLOS One, Paperwork Reduction Act of 1995, disorders. Specifically, the Committee
8(6):e67311, 2013. HRSA has submitted an Information makes systematic evidence-based
46. Park, B.J., K.A. Wannemuehler, B.J. Collection Request (ICR) to the Office of recommendations on newborn screening
Marston, et al., ‘‘Estimation of the Management and Budget (OMB) for for conditions that have the potential to
Current Global Burden of Cryptococcal change the health outcomes for
Meningitis Among Persons Living with
review and approval. Comments
submitted during the first public review newborns.
HIV/AIDS,’’ AIDS, 23:525–530, 2009. The Committee tasks an external
47. Mirza, S.A., M. Phelan, D. Rimland, et al., of this ICR will be provided to OMB.
OMB will accept further comments from workgroup to conduct systematic
‘‘The Changing Epidemiology of
the public during the review and evidence-based reviews for conditions
Cryptococcosis: An Update from
Population-Based Active Surveillance in being considered for addition to the
approval period.
2 Large Metropolitan Areas, 1992–2000,’’ Recommended Uniform Screening
DATES: Comments on this ICR should be Panel, and their corresponding newborn
Clinical Infectious Diseases, 36(6):789–
794, 2003. received no later than September 24, screening test(s), confirmatory test(s),
48. Pyrgos, V., A.E. Seitz, C.A. Steiner, et al., 2018. and treatment(s). Reviews also include
‘‘Epidemiology of Cryptococcal ADDRESSES: Submit your comments to an analysis of the benefits and harms of
Meningitis in the US: 1997–2009,’’ PLOS newborn screening for a selected
paperwork@hrsa.gov or mail the HRSA
One, 8(2):e56269, 2013. condition at a population level and an
49. CDC, ‘‘Emergence of Cryptococcus Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers assessment of state public health
gattii—Pacific Northwest, 2004–2010,’’
Lane, Rockville, MD 20857. newborn screening programs’ ability to
Morbidity and Mortality Weekly Report,
59(28):865–868, 2010 available at https:// implement the screening of a new
FOR FURTHER INFORMATION CONTACT: To
www.cdc.gov/mmwr/preview/ condition.
request a copy of the clearance requests Need and Proposed Use of the
mmwrhtml/mm5928a1.htm?s_ submitted to OMB for review, email Lisa
cid=mm5928a1_w. Information: HRSA proposes that the
50. Espinel-Ingroff, A. and S.E. Kidd,
Wright-Solomon, the HRSA Information data collection surveys be administered
‘‘Current Trends in the Prevalence of Collection Clearance Officer at by the Committee’s external Evidence
Cryptococcus Gattii in the United States paperwork@hrsa.gov or call (301) 443– Review Group to all state newborn
and Canada,’’ Infection and Drug 1984. screening programs in the United States
daltland on DSKBBV9HB2PROD with NOTICES
Resistance, 8:89–97, May 11, 2015. SUPPLEMENTARY INFORMATION: up to twice a year for two conditions.
51. WHO, ‘‘Rapid Advice: Diagnosis,
Information Collection Request Title: The surveys were developed to capture
Prevention and Management of
Cryptococcal Disease in HIV-Infected The Secretary’s Discretionary Advisory the following: (1) The readiness of state
Adults, Adolescents and Children,’’ Committee on Heritable Disorders in public health newborn screening
December 2011; available at http:// Newborns and Children’s Public Health programs to expand newborn screening
www.who.int/hiv/pub/cryptococcal_ System Assessment Surveys OMB No. to include the target condition; (2)
disease2011/ (accessed August 8, 2016). 0906–0014—Revised. specific requirements of screening for
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![Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42911
the condition that could hinder or and new questions were added to Burden Statement: Burden in this
facilitate its implementation in each address gaps in information identified context means the time expended by
state; and (3) estimated timeframes by those who have completed the persons to generate, maintain, retain,
needed for each state to complete major survey and utilized the survey results. disclose or provide the information
milestones toward full newborn The data gathered will inform the requested. This includes the time
screening of the condition. Committee on the following: (1) needed to review instructions; to
HRSA published the 60-day notice on develop, acquire, install and utilize
Feasibility of implementing population-
June 5, 2018 (FR Doc. 2018–12019). technology and systems for the purpose
based screening for the target condition;
There were no comments received of collecting, validating and verifying
(2) readiness of state newborn screening
during the 60-day comment period. The information, processing and
programs to adopt screening for the
survey tools have been revised to maintaining information, and disclosing
condition; (3) identify gaps in feasibility
streamline responses to decrease the and providing information; to train
burden on the respondents, provide or readiness to screen for the condition; personnel and to be able to respond to
clarity with regard to what is being and (4) identify areas of technical a collection of information; to search
asked, ensure the survey can assistance and resources needed to data sources; to complete and review
accommodate different types of facilitate screening for conditions with the collection of information; and to
conditions that may be nominated in the low feasibility or readiness. transmit or otherwise disclose the
future, and offer additional response Likely Respondents: The respondents information. The total annual burden
options. To accomplish this, questions to the survey will be State and territorial hours estimated for this ICR are
were deleted, consolidated, reordered, newborn screening programs. summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
INITIAL 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
FOLLOW-UP Survey of the Secretary’s Discretionary Ad-
visory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment .......... * 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, advisory committees, and applies to the and Pensions, and the House of
Acting Director, Division of the Executive extent that the provisions of FACA do Representatives Committee on Energy
Secretariat. not conflict with the requirements of and Commerce on matters concerning
[FR Doc. 2018–18292 Filed 8–23–18; 8:45 am] PHS Act Section 749. policy, program development, and other
BILLING CODE 4165–15–P DATES: HRSA will receive nominations matters of significance concerning the
on a continuous basis. medicine and dentistry activities under
Section 747 of the PHS Act, as it existed
ADDRESSES: Written nominations for
DEPARTMENT OF HEALTH AND upon the enactment of Section 749 of
membership can be submitted by mail
HUMAN SERVICES the PHS Act in 1998. In addition, the
to Advisory Council Operations, Bureau
ACTPCMD develops, publishes, and
Request for Nominations for the of Health Workforce, HRSA, Room
implements performance measures and
Advisory Committee on Training in 11W45C, 5600 Fishers Lane, Rockville,
longitudinal evaluations for programs
Primary Care Medicine and Dentistry Maryland 20857 or sent by email to
under Part C of Title VII of the PHS Act,
BHWAdvisoryCouncilFRN@hrsa.gov.
AGENCY: Health Resources and Services as well as recommends appropriation
FOR FURTHER INFORMATION CONTACT: levels for programs under this part.
Administration (HRSA), Department of Kennita R. Carter, MD, Designated
Health and Human Services (HHS). Meetings are held twice a year.
Federal Official, ACTPCMD at 301–945– Specifically, HRSA is requesting
ACTION: Notice of request for 3505 or email kcarter@hrsa.gov. A copy
nominations. nominations for voting members of the
of the current committee membership, ACTPCMD representing allopathic
SUMMARY: HRSA is requesting charter, and reports can be obtained by medicine, osteopathic medicine, family
nominations to fill vacancies on the accessing the ACTPCMD website medicine, general internal medicine,
Advisory Committee on Training in https://www.hrsa.gov/advisory- general pediatrics, physician assistant,
Primary Care Medicine and Dentistry committees/primarycare-dentist/ general dentistry, pediatric dentistry,
daltland on DSKBBV9HB2PROD with NOTICES
(ACTPCMD). The ACTPCMD is index.html. public health dentistry, dental hygiene,
authorized by Section 749 of the Public SUPPLEMENTARY INFORMATION: The advanced practice nurse programs, and
Health Service (PHS) Act. The Advisory ACTPCMD provides advice and other health professionals engaged in
Committee is governed by provisions of recommendations to the Secretary of the primary care or oral health
the Federal Advisory Committee Act Department of Health and Human interprofessional training. Among these
(FACA), as amended, which sets forth Services (Secretary), the Senate nominations, students, residents, or
standards for the formation and use of Committee on Health, Education, Labor fellows representing allopathic
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Document Created: 2018-08-24 04:15:12
Document Modified: 2018-08-24 04:15:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than September 24, 2018. | |
| 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. | |
| FR Citation | 83 FR 42910 |
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