83 FR 5791 - Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Number: 0906-0017-Revision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5791-5793 | |
| FR Document | 2018-02594 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5791-5793] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02594] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Number: 0906-0017--Revision AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 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 April 10, 2018. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, 14N39, 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 paperwork@hrsa.gov 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. [[Page 5792]] Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Control Number: 0906-0017--Revision. Abstract: This clearance request is for continued approval of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Performance Measurement Information System. The MIECHV Program, administered by HRSA in partnership with the Administration for Children and Families, supports voluntary, evidence-based home visiting services during pregnancy women 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. HRSA is revising the data collection forms for the MIECHV Program by making the following changes:Form 1: Update all tables to include specific guidance to account for and report missing data. Form 1, Tables 1 and 2: Update table titles to reflect ``participants served by MIECHV.'' Form 1, Table 5: Update to reflect correct age categories of ``<1 year''; ``1-2 years''; ``3-4 years''; and ``5-6 years.'' Form 1, Table 8: Revise the category of ``Never Married'' to read ``Never Married (excluding not married but living together with partner).'' Form 1, Table 10: Delete. Form 1, Table 18: Delete. Form 1, Table 22: Revise to only include children greater than or equal to 12 months of age. Title will be updated to ``Index Children (>=12 months of age) by Usual Source of Dental Care.'' Form 1, Notes: Revise to include Table-specific notes. Form 1, Definition of Key Terms: Update definitions for Tables 1, 3, 5, 12, 13, 15, 17, 20, 21, and 22. Form 2: Update all measures to include specific guidance to account for and report missing data. Form 2, Measure 3: Update denominator to reflect correct inclusion criteria. Form 2, Measure 4: Update measure to benchmark receipt of well-child visits to specific ages. Form 2, Measure 9: Update numerator to clarify that investigated cases of maltreatment must have occurred within the reporting period. Form 2, Measure 10: Update denominator to clarify the appropriate unit of analysis is the index child. Form 2, Measure 14: Update measure to reflect current terminology and the timing within which screenings should be reported. Form 2, Measure 15: Update measure and numerator to include primary caregivers enrolled in middle school. Form 2, Measure 16: Update numerator to reflect correct inclusion criteria. Form 2, Measure 17: Update denominator to reflect correct inclusion criteria. Form 2, Measure 19: Update denominator to reflect correct inclusion criteria. Form 2, Definitions of Key Terms: Update definitions for measures 1-19. HRSA is also requesting an extension of this information collection request through November 30, 2021. Need and Proposed Use of the Information: HRSA uses performance information to demonstrate program accountability with legislative and program requirements 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 demographic, service utilization, and select clinical indicators for participants enrolled in home visiting services. In addition, HRSA will collect a set of standardized performance and outcome indicators that correspond with the statutorily identified benchmark areas. In the future, HRSA anticipates that MIECHV funding decisions may be allocated, in part, based on this data. This notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, information can be collected in a timely manner. Likely Respondents: MIECHV Program awardees. 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 Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- Form 1: Demographic, Service 56 1 56 560 31,360 Utilization, and Select Clinical Indicators............ Form 2: Performance Indicators 56 1 56 200 11,200 and Systems Outcome Measures... ------------------------------------------------------------------------------- Total....................... 56 .............. 56 .............. 42,560 ---------------------------------------------------------------------------------------------------------------- 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. [[Page 5793]] Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018-02594 Filed 2-8-18; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5791
10903 New Hampshire Ave., Bldg. 51, of the product. Thereafter, the USPTO Petitions should be in the format
Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the specified in 21 CFR 10.30.
301–796–3600. product’s regulatory review period. Submit petitions electronically to
SUPPLEMENTARY INFORMATION: https://www.regulations.gov at Docket
II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
I. Background Period petitions (two copies are required) to the
The Drug Price Competition and FDA has determined that the Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 applicable regulatory review period for Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic ONIVYDE is 2,536 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term 2,354 days occurred during the testing 20852.
Restoration Act (Pub. L. 100–670) phase of the regulatory review period, Dated: February 5, 2018.
generally provide that a patent may be while 182 days occurred during the Leslie Kux,
extended for a period of up to 5 years approval phase. These periods of time Associate Commissioner for Policy.
so long as the patented item (human were derived from the following dates: [FR Doc. 2018–02590 Filed 2–8–18; 8:45 am]
drug product, animal drug product, 1. The date an exemption under BILLING CODE 4164–01–P
medical device, food additive, or color section 505(i) of the Federal Food, Drug,
additive) was subject to regulatory and Cosmetic Act (FD&C Act) (21 U.S.C.
review by FDA before the item was 355(i)) became effective: November 13, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s 2008. FDA has verified the applicant’s HUMAN SERVICES
regulatory review period forms the basis claim that November 13, 2008, is the
for determining the amount of extension date the investigational new drug Health Resources and Services
an applicant may receive. application became effective. Administration
A regulatory review period consists of 2. The date the application was
two periods of time: A testing phase and initially submitted with respect to the Agency Information Collection
an approval phase. For human drug Activities: Proposed Collection: Public
human drug product under section
products, the testing phase begins when Comment Request, Information
505(b) of the FD&C Act: April 24, 2015.
the exemption to permit the clinical Collection Request Title: The Maternal,
FDA has verified the applicant’s claim
investigations of the drug becomes Infant, and Early Childhood Home
that the new drug application (NDA) for
effective and runs until the approval Visiting Program Performance
ONIVYDE (NDA 207793) was initially
phase begins. The approval phase starts Measurement Information System,
submitted on April 24, 2015.
with the initial submission of an OMB Number: 0906–0017—Revision
application to market the human drug 3. The date the application was
product and continues until FDA grants approved: October 22, 2015. FDA has AGENCY: Health Resources and Services
permission to market the drug product. verified the applicant’s claim that NDA Administration (HRSA), Department of
Although only a portion of a regulatory 207793 was approved on October 22, Health and Human Services.
review period may count toward the 2015. ACTION: Notice.
actual amount of extension that the This determination of the regulatory
review period establishes the maximum SUMMARY: In compliance with the
Director of USPTO may award (for
potential length of a patent extension. requirement for opportunity for public
example, half the testing phase must be
However, the USPTO applies several comment on proposed data collection
subtracted as well as any time that may
statutory limitations in its calculations projects of the Paperwork Reduction Act
have occurred before the patent was
of the actual period for patent extension. of 1995, HRSA announces plans to
issued), FDA’s determination of the
In its applications for patent extension, submit an Information Collection
length of a regulatory review period for
this applicant seeks 613 days or 1,215 Request (ICR), described below, to the
a human drug product will include all
days of patent term extension. Office of Management and Budget
of the testing phase and approval phase
(OMB). Prior to submitting the ICR to
as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions OMB, HRSA seeks comments from the
FDA has approved for marketing the
Anyone with knowledge that any of public regarding the burden estimate,
human drug product ONIVYDE
the dates as published are incorrect may below, or any other aspect of the ICR.
(irinotecan sucrose octasulfate).
ONIVYDE in combination with submit either electronic or written DATES: Comments on this ICR should be
fluorouracil and leucovorin, is indicated comments and, under 21 CFR 60.24, ask received no later than April 10, 2018.
for the treatment of patients with for a redetermination (see DATES). ADDRESSES: Submit your comments to
metastatic adenocarcinoma of the Furthermore, as specified in § 60.30 (21 paperwork@hrsa.gov or mail the HRSA
pancreas after disease progression CFR 60.30), any interested person may Information Collection Clearance
following gemcitabine-based therapy. petition FDA for a determination Officer, 14N39, 5600 Fishers Lane,
Subsequent to this approval, the USPTO regarding whether the applicant for Rockville, MD 20857.
received patent term restoration extension acted with due diligence FOR FURTHER INFORMATION CONTACT: To
applications for ONIVYDE (U.S. Patent during the regulatory review period. To request more information on the
Nos. 8,147,867 and 8,329,213) from meet its burden, the petition must proposed project or to obtain a copy of
Merrimack Pharmaceuticals, Inc., and comply with all the requirements of the data collection plans and draft
the USPTO requested FDA’s assistance § 60.30, including but not limited to: instruments, email paperwork@hrsa.gov
in determining the patents’ eligibility must be timely (see DATES), must be or call Lisa Wright-Solomon, the HRSA
sradovich on DSK3GMQ082PROD with NOTICES
for patent term restoration. In a letter filed in accordance with § 10.20, must Information Collection Clearance Officer
dated August 12, 2016, FDA advised the contain sufficient facts to merit an FDA at (301) 443–1984.
USPTO that this human drug product investigation, and must certify that a SUPPLEMENTARY INFORMATION: When
had undergone a regulatory review true and complete copy of the petition submitting comments or requesting
period and that the approval of has been served upon the patent information, please include the
ONIVYDE represented the first applicant. (See H. Rept. 857, part 1, 98th information request collection title for
permitted commercial marketing or use Cong., 2d sess., pp. 41–42, 1984.) reference.
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![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5793
Amy McNulty, decision by HHS to add the class to the Attitudes and Practices, OMB No. 0915–
Acting Director, Division of the Executive SEC. 0290—Reinstatement With Change
Secretariat. Abstract: HRSA is requesting
John Howard, approval from OMB for a reinstatement
[FR Doc. 2018–02594 Filed 2–8–18; 8:45 am]
Director, National Institute for Occupational with change of a previously approved
BILLING CODE 4165–15–P
Safety and Health. collection of information (OMB control
[FR Doc. 2018–02675 Filed 2–8–18; 8:45 am] number 0915–0290). The National
DEPARTMENT OF HEALTH AND BILLING CODE 4163–19–P Survey of Organ Donation Attitudes and
HUMAN SERVICES Practices (NSODAP) is conducted
approximately every 6–7 years and
Designation of a Class of Employees DEPARTMENT OF HEALTH AND serves a critical role in providing HRSA
for Addition to the Special Exposure HUMAN SERVICES and the donation community with data
Cohort regarding why Americans choose to
Health Resources and Services
donate organs, current barriers to
National Institute for Administration
AGENCY: donation, and potential new approaches
Occupational Safety and Health Agency Information Collection to increasing donations. Survey data
(NIOSH), Centers for Disease Control Activities: Proposed Collection: Public and derived analytic insights inform
and Prevention, Department of Health Comment Request; Information HRSA’s public outreach and
and Human Services (HHS). Collection Request Title: National educational initiatives. HRSA is
Survey of Organ Donation Attitudes improving the quality and relevance of
ACTION: Notice. the data collected by making the
and Practices, OMB No. 0915–0290—
Reinstatement With Change following changes:
SUMMARY: HHS gives notice of a (1) HRSA is increasing the ability to
decision to designate a class of produce more precise results by
AGENCY: Health Resources and Services
employees from the Ames Laboratory in targeting 10,000 completed surveys
Administration (HRSA), Department of
Ames, Iowa, as an addition to the (increased from 3,250 in 2012). This
Health and Human Services.
Special Exposure Cohort (SEC) under increase will allow for a more accurate
the Energy Employees Occupational ACTION: Notice.
and robust analysis of the attitudes and
Illness Compensation Program Act of donation practices of important
2000. SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, subgroups such as Americans over the
HRSA announces plans to submit an age of 50 and various minority
FOR FURTHER INFORMATION CONTACT:
Information Collection Request (ICR), populations. While the precision of the
Stuart L. Hinnefeld, Director, Division results from the survey will increase,
of Compensation Analysis and Support, described below, to the Office of
Management and Budget (OMB). The respondent burden will be reduced and
NIOSH, 1090 Tusculum Avenue, MS C– survey completion costs will be lower
46, Cincinnati, OH 45226–1938, ICR is for reinstatement with change of
a previously approved information resulting in a cost neutral change.
Telephone 1–877–222–7570. (2) HRSA is streamlining the data
Information requests can also be collection, assigned OMB control
collection process to minimize
submitted by email to DCAS@CDC.GOV. number 0915–0290, which expired on
respondent burden. Of the 10,000
March 31, 2015. Prior to submitting the targeted completed surveys, 8,000 will
SUPPLEMENTARY INFORMATION: ICR to OMB, HRSA seeks comments be completed online by a nationally
Authority: 42 U.S.C. 7384q(b). 42 U.S.C. from the public regarding the burden representative web panel composed of
7384l(14)(C). estimate below or any other aspect of Americans over the age of 18 who have
the ICR. already agreed to participate in a survey.
On February 1, 2018, as provided for DATES: Comments on this ICR should be Web panels target a representative
under 42 U.S.C. 7384l(14)(C), the received no later than April 10, 2018. section of a population used by other
Secretary of HHS designated the approved surveys. HRSA will complete
ADDRESSES: Submit your comments to
following class of employees as an the remaining 2,000 surveys by
paperwork@hrsa.gov or mail the HRSA
addition to the SEC: telephone. In 2012, all 3,250 surveys
Information Collection Clearance
All employees of the Department of Officer, 14N39, 5600 Fishers Lane, were conducted by telephone and
Energy, its predecessor agencies, and their Rockville, MD 20857. respondents were contacted using
contractors or subcontractors who worked in random-digit dialing, a process that
any area of the Ames Laboratory in Ames, FOR FURTHER INFORMATION CONTACT: To
yielded a low response rate. Contacting
Iowa, during the period from January 1, 1971, request more information on the respondents by telephone will remain a
through December 31, 1989, for a number of proposed project or to obtain a copy of part of the survey protocol to compare
work days aggregating at least 250 work days, the data collection plans and draft current data to the 2012 data. However,
occurring either solely under this instruments, email paperwork@hrsa.gov for this survey, identification of a
employment or in combination with work or call Lisa Wright-Solomon, the HRSA
days within the parameters established for
sample of adults over the age of 18 for
Information Collection Clearance Officer a telephone survey will be from a
one or more other classes of employees at (301) 443–1984.
included in the Special Exposure Cohort. national list of home addresses. Prior to
SUPPLEMENTARY INFORMATION: When contact, those selected for the telephone
This designation will become submitting comments or requesting survey will receive a mailed pre-
sradovich on DSK3GMQ082PROD with NOTICES
effective on March 3, 2018, unless information, please include the notification letter with information
Congress provides otherwise prior to the information request collection title for about the survey. This mailing will
effective date. After this effective date, reference, in compliance with Section improve survey cooperation and reduce
HHS will publish a notice in the 3506(c)(2)(A) of the Paperwork the number of people contacted for the
Federal Register reporting the addition Reduction Act of 1995. survey. Additionally, it is more time
of this class to the SEC or the result of Information Collection Request Title: and cost effective to take the survey
any provision by Congress regarding the National Survey of Organ Donation online than taking the survey by phone
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Document Created: 2018-02-09 00:12:10
Document Modified: 2018-02-09 00:12:10
| 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 April 10, 2018. | |
| 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. | |
| FR Citation | 83 FR 5791 |
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