82 FR 7836 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 13 (January 23, 2017)

Page Range		7836-7837
FR Document		2017-01276

Federal Register, Volume 82 Issue 13 (Monday, January 23, 2017)

[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7836-7837]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Proposed Project: Performance Reporting for the Tribal Maternal, 
Infant, and Early Childhood Home Visiting Grant Program.
    Title: Tribal Maternal, Infant, and Early Childhood Home Visiting 
Program Performance Reporting Form 2.
    OMB No.: New Collection.
    Description: Social Security Act, Title V, Section 511 (42 U.S.C. 
711), as added by Sec.  2951 of the Patient Protection and Affordable 
Care Act (Pub. L. 111-148), created the Maternal, Infant, and Early 
Childhood Home Visiting Program (MIECHV) and authorized the Secretary 
of HHS (in Section 511(h)(2)(A)) to award grants to Indian tribes (or a 
consortium of Indian tribes), tribal organizations, or urban Indian 
organizations to conduct an early childhood home visiting program. The 
legislation set aside 3 percent of the total MIECHV program 
appropriation (authorized in Section 511(j)) for grants to tribal 
entities. The implementation of the program is a collaborative endeavor 
between Health Resources Services Administration (HRSA) and the 
Administration for Children and Families (ACF). HRSA administers the 
State MIECHV program while ACF administers the Tribal MIECHV program. 
The goal of the Tribal MIECHV program is to support the development of 
happy, healthy, and successful American Indian and Alaska Native 
children and families through a coordinated home visiting system. 
Tribal MIECHV grants, to the greatest extent practicable, are to be 
consistent with the requirements of the MIECHV grants to states and 
jurisdictions (authorized in Section 511(c)), and include conducting a 
needs assessment and establishing quantifiable, measurable benchmarks.
    Specifically, the MIECHV legislation requires that State and Tribal 
MIECHV grantees collect data to measure improvements for eligible 
families in six specified areas (referred to as ``benchmark areas'') 
that encompass the major goals for the program and are listed below:
    1. Improved maternal and newborn health;
    2. Prevention of child injuries, child abuse, neglect, or 
maltreatment, and reduction in emergency department visits;
    3. Improvement in school readiness and achievement;
    4. Reduction in crime or domestic violence;
    5. Improvement in family economic self-sufficiency;
    6. Improvement in the coordination and referrals for other 
community resources and supports.

Tribal Home Visiting (HV) Form 2--Tribal Grantees Performance Reporting

    The proposed Tribal HV Form 2 will be used by two new cohorts of 
Tribal MIECHV grantees that were funded in FY2016 to report their 
benchmark performance measures. As stipulated in the MIECHV 
legislation, the Tribal MIECHV grantees, like their State counterparts, 
must meet the required reporting of benchmark areas. Tribal MIECHV 
grantees are required to propose a plan for meeting the benchmark 
requirements specified in the legislation and must report on 
improvement at the end of Year 4 and Year 5 of their 5-year grants, 
(i.e. after 3 years of implementation and at the end of their 5-year 
grant).
    The Tribal HV Form 2 will be used by Tribal MIECHV grantees 
beginning in October 2018 pending OMB approval. The Tribal HV Form 2 is 
new to the MIECHV Program information system and is remotely similar to 
the currently-approved Tribal HV Form 3 (OMB #0915-0357). The creation 
of Tribal HV Form 2 is due to the added level of specificity and 
revised performance reporting requirements for grantees to report 
benchmarks data.
    Specifically, ACF will use the proposed Tribal HV Form 2 to:
     Track and improve the quality of benchmark measure data 
submitted by the Tribal grantees;
     Improve program monitoring and oversight;
     Improve rigorous data analyses that help to assess the 
effectiveness of the programs and enable ACF to better monitor 
projects; and

[[Page 7837]]

     Ensure adequate and timely reporting of program data to 
relevant federal agencies and stakeholders including the Congress, and 
members of the public.
    Tribal HV Form 2 will provide a template for Tribal MIECHV grantees 
to report data on their progress under the six benchmark areas as 
stipulated in legislation.
    Respondents: Tribal Maternal, Infant, and Early Childhood Home 
Visiting Program Grantees.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses per      hours  per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Tribal Maternal, Infant, and Early Childhood              20                1              500           10,000
 Home Visiting Performance Reporting Form...
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 10,000.
    In compliance with the requirements of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 330 C St. SW., Washington, DC 20201, 
Attn: OPRE Reports Clearance Officer. Email address: 
[email protected]. All requests should be identified by 
the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017-01276 Filed 1-19-17; 8:45 am]
 BILLING CODE 4184-01-P

Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7837

• Ensure adequate and timely Tribal HV Form 2 will provide a Respondents: Tribal Maternal, Infant,
reporting of program data to relevant template for Tribal MIECHV grantees to and Early Childhood Home Visiting
federal agencies and stakeholders report data on their progress under the Program Grantees.
including the Congress, and members of six benchmark areas as stipulated in
the public. legislation.

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Tribal Maternal, Infant, and Early Childhood Home Visiting Performance Re-
porting Form ................................................................................................. 20 1 500 10,000

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND clinical testing otherwise necessary to
Hours: 10,000. HUMAN SERVICES gain approval of a new drug application
In compliance with the requirements (NDA).
Food and Drug Administration The 1984 amendments include what
of Section 3506(c)(2)(A) of the
is now section 505(j)(7) of the Federal
Paperwork Reduction Act of 1995, the [Docket No. FDA–2014–P–0377]
Food, Drug, and Cosmetic Act (21 U.S.C.
Administration for Children and
Determination That ACTHAR GEL 355(j)(7)), which requires FDA to
Families is soliciting public comment
SYNTHETIC (Seractide Acetate) publish a list of all approved drugs.
on the specific aspects of the FDA publishes this list as part of the
Injection, 80 Units/Milliliter and 40
information collection described above. ‘‘Approved Drug Products With
Units/Milliliter, Was Withdrawn From
Copies of the proposed collection of Therapeutic Equivalence Evaluations,’’
Sale for Reasons of Safety or
information can be obtained and which is known generally as the
Effectiveness
comments may be forwarded by writing ‘‘Orange Book.’’ Under FDA regulations,
to the Administration for Children and AGENCY: Food and Drug Administration, drugs are removed from the list if the
Families, Office of Planning, Research HHS. Agency withdraws or suspends
and Evaluation, 330 C St. SW., ACTION: Notice. approval of the drug’s NDA or ANDA
Washington, DC 20201, Attn: OPRE for reasons of safety or effectiveness or
Reports Clearance Officer. Email SUMMARY: The Food and Drug if FDA determines that the listed drug
address: OPREinfocollection@ Administration (FDA or we) has was withdrawn from sale for reasons of
acf.hhs.gov. All requests should be determined that ACTHAR GEL safety or effectiveness (21 CFR 314.162).
identified by the title of the information SYNTHETIC (seractide acetate) A person may petition the Agency to
collection. injection, 80 units/milliliter (mL) and 40 determine, or the Agency may
units/mL, was withdrawn from sale for determine on its own initiative, whether
The Department specifically requests reasons of safety or effectiveness. The a listed drug was withdrawn from sale
comments on: (a) Whether the proposed Agency will not accept or approve for reasons of safety or effectiveness.
collection of information is necessary abbreviated new drug applications This determination may be made at any
for the proper performance of the (ANDAs) for seractide acetate injection, time after the drug has been withdrawn
functions of the agency, including 80 units/mL and 40 units/mL. from sale, but must be made prior to
whether the information shall have FOR FURTHER INFORMATION CONTACT: approving an ANDA that refers to the
practical utility; (b) the accuracy of the David E. Markert, Center for Drug listed drug (21 CFR 314.161). FDA may
agency’s estimate of the burden of the Evaluation and Research, Food and not approve an ANDA that does not
proposed collection of information; (c) Drug Administration, 10903 New refer to a listed drug.
the quality, utility, and clarity of the Hampshire Ave., Bldg. 51, Rm. 6222, ACTHAR GEL SYNTHETIC (seractide
information to be collected; and (d) Silver Spring, MD 20993–0002, 301– acetate) injection, 80 units/mL and 40
ways to minimize the burden of the 796–0752. units/mL was the subject of NDA
collection of information on SUPPLEMENTARY INFORMATION: 017861, which was held by Armour
respondents, including through the use Pharmaceutical Co. (Armour), and
of automated collection techniques or I. Background initially approved on February 21, 1978.
other forms of information technology. In 1984, Congress enacted the Drug ACTHAR GEL SYNTHETIC is indicated
Consideration will be given to Price Competition and Patent Term for diagnostic testing of adrenocortical
comments and suggestions submitted Restoration Act of 1984 (Pub. L. 98–417) function. The labeling also provides that
within 60 days of this publication. (the 1984 amendments), which ACTHAR GEL SYNTHETIC may be
authorized the approval of duplicate employed in the following disorders:
Mary Jones, versions of drug products under an Endocrine Disorders: Nonsuppurative
ACF/OPRE Certifying Officer. ANDA procedure. ANDA applicants thyroiditis; Hypercalcemia associated
must, with certain exceptions, show that with cancer.
mstockstill on DSK3G9T082PROD with NOTICES

[FR Doc. 2017–01276 Filed 1–19–17; 8:45 am]
BILLING CODE 4184–01–P the drug for which they are seeking Nervous System Diseases: Acute
approval contains the same active exacerbations of multiple sclerosis.
ingredient in the same strength and Rheumatic Disorders: As adjunctive
dosage form as the ‘‘listed drug,’’ which therapy for short-term administration (to
is a version of the drug that was tide the patient over an acute episode or
previously approved. ANDA applicants exacerbation) in: Psoriatic arthritis;
do not have to repeat the extensive rheumatoid arthritis, including juvenile

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Document Created: 2017-01-20 01:29:21
Document Modified: 2017-01-20 01:29:21

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
FR Citation		82 FR 7836

82 FR 7836 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 82, Issue 13 (January 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families