80 FR 80777 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 248 (December 28, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 248 (December 28, 2015)
| Page Range | 80777-80778 | |
| FR Document | 2015-32549 |
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)] [Notices] [Pages 80777-80778] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32549] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the 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 Information Collection Request must be received no later than February 26, 2016. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 10C-24, Parklawn Building, 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 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. Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Program--Quality Improvement Data Collection. OMB No. 0915-xxxx-New Abstract: In response to the growing need for resources devoted to sickle cell disease and other hemoglobinopathies, the United States Congress, under Section 712 of the American Jobs Creation Act of 2004 (Pub. L. 108-357) (42 U.S.C. 300b-1 note), authorized a demonstration program for the prevention and treatment of sickle cell disease (SCD) to be administered by the Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA) in the U.S. Department of Health and Human Services. The program is known as the Sickle Cell Disease Treatment Demonstration Program (SCDTDP). The SCDTDP is designed to improve access to services for individuals with sickle cell disease, improve and expand patient and provider education, and improve and expand the continuity and coordination of service delivery for individuals with sickle cell disease and sickle cell trait. The specific aims for the program are threefold: (1) Increase the number of providers treating persons with sickle cell disease, (2) increase the number of providers prescribing hydroxyurea, and (3) increase the number of providers knowledgeable about treating sickle cell disease as well as increase the number of sickle cell patients that are seen by providers knowledgeable about sickle cell disease. To achieve the goals and objectives of the program, the SCDTDP uses quality improvement (QI) methods in a collective impact model which supports cross-sector collaboration for achieving measurable effects on major social issues. The collective impact model requires shared measurement which facilitates tracking progress in a standardized method in order to promote learning and enhance continuous improvement. Need and Proposed Use of the Information: The purpose of the proposed data collection strategy is to implement a system to monitor the progress of MCHB-funded activities in improving care and health outcomes for individuals living with sickle cell disease/trait and meeting the goals of the SCDTDP. Each regional grantee site will be asked to report on a core set of evidence-based measures related to healthcare utilization among individuals with sickle cell disease and the quality of care of the SCD population. The data collected for the Sickle Cell Disease Treatment Demonstration Program will consist of administrative medical claims data collected from State Medicaid Programs and Medicaid Managed Care Organizations that administer Medicaid on behalf of states. The data is collected either for or by State Medicaid offices for delivery of services subject to Medicaid reimbursement. The data collection strategy will provide an effective and efficient mechanism to do the following: (1) Assess the improvements in access to care for sickle cell patients provided by activities in the SCDTDP; (2) collect, coordinate, and distribute data, best practices, and findings from regional grantee sites to drive improvement on quality measures; (3) refine a common model protocol regarding the prevention and treatment of sickle cell disease; (4) examine/address barriers that individuals and families living with sickle cell disease face when accessing quality health care and health education; (5) evaluate the grantees' performance in meeting the objectives of the SCDTDP; and (6) provide HRSA and Congress with information on the overall progress of the program. Likely Respondents: Four regional grantee sites funded by HRSA under the SCDTDP will be the respondents for this data collection activity and submit responses gathered from State Medicaid [[Page 80778]] Offices and State Medicaid Managed Care Organizations (MCOs). 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. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total responses per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- SCDTDP Data form............ 4 Range:16-80.... Range:64-320... Range:4-6...... Range:256-1920 ----------------------------------------------------------------------------------- Total................... 4 Range:16-80.... Range:64-320... Range:4-6...... Range:256-1920. ---------------------------------------------------------------------------------------------------------------- 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-32549 Filed 12-24-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices 80777
open to participating in a well-designed Paperwork Reduction Act of 1995), the about treating sickle cell disease as well
and well-conducted meeting on a case- Health Resources and Services as increase the number of sickle cell
by-case basis. Given the expanse of Administration (HRSA) announces patients that are seen by providers
diseases affecting the U.S. patient plans to submit an Information knowledgeable about sickle cell disease.
population and the effort required to Collection Request (ICR), described To achieve the goals and objectives of
conduct a successful PFDD meeting, below, to the Office of Management and the program, the SCDTDP uses quality
externally-led PFDD meetings should Budget (OMB). Prior to submitting the improvement (QI) methods in a
target disease areas where there is an ICR to OMB, HRSA seeks comments collective impact model which supports
identified need for patient input on from the public regarding the burden cross-sector collaboration for achieving
topics related to drug development. estimate, below, or any other aspect of measurable effects on major social
FDA will determine its level of the ICR. issues. The collective impact model
participation in these meetings on an DATES: Comments on this Information requires shared measurement which
individual basis, taking into account a Collection Request must be received no facilitates tracking progress in a
number of factors, including any later than February 26, 2016. standardized method in order to
identified need for a better ADDRESSES: Submit your comments to promote learning and enhance
understanding of patient perspective, paperwork@hrsa.gov or mail the HRSA continuous improvement.
recent interactions with patient Information Collection Clearance Need and Proposed Use of the
stakeholders, proposed meeting details, Officer, Room 10C–24, Parklawn Information: The purpose of the
and FDA staff capacity. More Building, 5600 Fishers Lane, Rockville, proposed data collection strategy is to
information regarding considerations to MD 20857. implement a system to monitor the
take into account when deciding to plan FOR FURTHER INFORMATION CONTACT: To progress of MCHB-funded activities in
an externally-led PFDD meeting can be request more information on the improving care and health outcomes for
found on this Web site: http:// proposed project or to obtain a copy of individuals living with sickle cell
www.fda.gov/ForIndustry/UserFees/ the data collection plans and draft disease/trait and meeting the goals of
PrescriptionDrugUserFee/ instruments, email paperwork@hrsa.gov the SCDTDP. Each regional grantee site
ucm453856.htm. or call the HRSA Information Collection will be asked to report on a core set of
FDA recommends that patient Clearance Officer at (301) 443–1984. evidence-based measures related to
organizations who are interested in healthcare utilization among
SUPPLEMENTARY INFORMATION: When
conducting an externally-led PFDD individuals with sickle cell disease and
submitting comments or requesting
meeting submit an LOI that the quality of care of the SCD
information, please include the
communicates (1) the value of the population.
information request collection title for
proposed meeting in the context of drug The data collected for the Sickle Cell
reference.
development for a particular disease Information Collection Request Title: Disease Treatment Demonstration
area, and (2) important details regarding Sickle Cell Disease Treatment Program will consist of administrative
the meeting plan. Guidelines for Demonstration Program—Quality medical claims data collected from State
developing a letter of intent are Improvement Data Collection. Medicaid Programs and Medicaid
provided here: http://www.fda.gov/ OMB No. 0915–xxxx–New Managed Care Organizations that
downloads/ForIndustry/UserFees/ Abstract: In response to the growing administer Medicaid on behalf of states.
PrescriptionDrugUserFee/ need for resources devoted to sickle cell The data is collected either for or by
UCM453857.pdf. Please submit the disease and other hemoglobinopathies, State Medicaid offices for delivery of
letter of intent to patientfocused@ the United States Congress, under services subject to Medicaid
fda.hhs.gov. FDA’s CDER Office of Section 712 of the American Jobs reimbursement.
Strategic Programs will receive and Creation Act of 2004 (Pub. L. 108–357) The data collection strategy will
review the letter. (42 U.S.C. 300b–1 note), authorized a provide an effective and efficient
Dated: December 21, 2015. demonstration program for the mechanism to do the following: (1)
Leslie Kux, prevention and treatment of sickle cell Assess the improvements in access to
Associate Commissioner for Policy. disease (SCD) to be administered by the care for sickle cell patients provided by
[FR Doc. 2015–32476 Filed 12–24–15; 8:45 am] Maternal and Child Health Bureau activities in the SCDTDP; (2) collect,
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(MCHB) of the Health Resources and coordinate, and distribute data, best
Services Administration (HRSA) in the practices, and findings from regional
U.S. Department of Health and Human grantee sites to drive improvement on
DEPARTMENT OF HEALTH AND Services. The program is known as the quality measures; (3) refine a common
HUMAN SERVICES Sickle Cell Disease Treatment model protocol regarding the prevention
Demonstration Program (SCDTDP). The and treatment of sickle cell disease; (4)
Health Resources and Services SCDTDP is designed to improve access examine/address barriers that
Administration to services for individuals with sickle individuals and families living with
cell disease, improve and expand sickle cell disease face when accessing
Agency Information Collection patient and provider education, and quality health care and health
Activities: Proposed Collection: Public improve and expand the continuity and education; (5) evaluate the grantees’
Comment Request coordination of service delivery for performance in meeting the objectives of
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY: Health Resources and Services individuals with sickle cell disease and the SCDTDP; and (6) provide HRSA and
Administration, HHS. sickle cell trait. The specific aims for the Congress with information on the
ACTION: Notice. program are threefold: (1) Increase the overall progress of the program.
number of providers treating persons Likely Respondents: Four regional
SUMMARY: In compliance with the with sickle cell disease, (2) increase the grantee sites funded by HRSA under the
requirement for opportunity for public number of providers prescribing SCDTDP will be the respondents for this
comment on proposed data collection hydroxyurea, and (3) increase the data collection activity and submit
projects (Section 3506(c)(2)(A) of the number of providers knowledgeable responses gathered from State Medicaid
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![80778 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
Offices and State Medicaid Managed develop, acquire, install and utilize data sources; to complete and review
Care Organizations (MCOs). technology and systems for the purpose the collection of information; and to
Burden Statement: Burden in this of collecting, validating and verifying transmit or otherwise disclose the
context means the time expended by information, processing and information. The total annual burden
persons to generate, maintain, retain, maintaining information, and disclosing hours estimated for this Information
disclose or provide the information and providing information; to train Collection Request are summarized in
requested. This includes the time personnel and to be able to respond to the table below.
needed to review instructions; to a collection of information; to search
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per
Number of Number of responses
Form name Total responses response Total burden hours
respondents per respondent (in hours)
SCDTDP Data form ...... 4 Range:16–80 ............... Range:64–320 ............. Range:4–6 ................... Range:256–1920
Total ....................... 4 Range:16–80 ............... Range:64–320 ............. Range:4–6 ................... Range:256–1920.
HRSA specifically requests comments ACTION: Notice. information, please include the OMB
on (1) The necessity and utility of the control number 0945–0002 for
proposed information collection for the SUMMARY: In compliance with section
reference.
proper performance of the agency’s 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Proposed Project: Complaint Forms
functions, (2) the accuracy of the
Secretary (OS), Department of Health for Discrimination; Health Information
estimated burden, (3) ways to enhance
and Human Services, has submitted an Privacy Complaints OMB No. 0945–
the quality, utility, and clarity of the
information to be collected, and (4) the Information Collection Request (ICR), 0002—Extension—Office of Civil Rights
use of automated collection techniques described below, to the Office of Abstract: The Office for Civil Rights is
or other forms of information Management and Budget (OMB) for seeking an extension on an approval for
technology to minimize the information review and approval. The ICR is for a 3-year clearance on a previous
collection burden. renewal of the approved information collection. Individuals may file written
collection assigned OMB control
Jackie Painter,
complaints with the Office for Civil
number 0945–0002, scheduled to expire
Rights when they believe they have
Director, Division of the Executive Secretariat. on December 31, 2015. Comments
submitted during the first public review been discriminated against by programs
[FR Doc. 2015–32549 Filed 12–24–15; 8:45 am]
of this ICR will be provided to OMB. or entities that receive Federal financial
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OMB will accept further comments from assistance from the Health and Human
the public on this ICR during the review Service or if they believe that their right
DEPARTMENT OF HEALTH AND and approval period. to the privacy of protected health
HUMAN SERVICES DATES: Comments on the ICR must be information has been violated. Annual
received on or before January 27, 2016. Number of Respondents frequency of
Office of the Secretary ADDRESSES: Submit your comments to submission is record keeping and
[Document Identifier HHS–OS–0945–0002– OIRA_submission@omb.eop.gov or via reporting on occasion.
30D] facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection Information Collection Clearance staff,
Activities; Submission to OMB for Information.CollectionClearance@
Review and Approval; Public Comment hhs.gov or (202) 690–6162.
Request
SUPPLEMENTARY INFORMATION: When
AGENCY: Office of the Secretary, HHS. submitting comments or requesting
ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Number of Total burden
Forms Type of respondent responses per burden hours
respondents hours
respondent per response
Civil Rights Complaint Form ............. Individuals or households, Not-for- 3493 1 45/60 2620
profit institutions.
Health Information Privacy Com- Individuals or households, Not-for- 10,286 1 45/60 7715
plaint Form. profit institutions.
Total ........................................... ........................................................... ........................ ........................ ........................ 10,335
mstockstill on DSK4VPTVN1PROD with NOTICES
Terry S. Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–32551 Filed 12–24–15; 8:45 am]
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Document Created: 2018-03-02 09:23:43
Document Modified: 2018-03-02 09:23:43
| 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 Information Collection Request must be received no later than February 26, 2016. | |
| 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 the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 80777 |
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