83 FR 64128 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 83, Issue 239 (December 13, 2018)
Administration for Children and Families
Federal Register Volume 83, Issue 239 (December 13, 2018)
| Page Range | 64128-64130 | |
| FR Document | 2018-27041 |
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)] [Notices] [Pages 64128-64130] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-27041] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Regional Partnership Grant National Cross-Site Evaluation and Evaluation Technical Assistance. OMB No.: 0970-NEW. Description: The Children's Bureau (CB) within the Administration for Children and Families of the U.S. Department of Health and Human Services seeks approval to collect information for the Regional Partnership Grants to Increase the Well-being of and to Improve Permanency Outcomes for Children Affected by Substance Abuse (known as the Regional Partnership Grants Program or ``RPG'') Cross-Site Evaluation and Evaluation-Related Technical Assistance project. The Child and Family Services Improvement and Innovation Act (Pub. L. 112- 34) includes a targeted grants program (section 437(f) of the Social Security Act) that directs the Secretary of Health and Human Services to reserve a specified portion of the appropriation for these Regional Partnership Grants, to be used to improve the well-being of children affected by substance abuse. Under three prior rounds of RPG, the Children's Bureau has issued 74 grants to organizations such as child welfare or substance abuse treatment providers or family court systems to develop interagency collaborations and integration of programs, activities, and services designed to increase well-being, improve permanency, and enhance the safety of children who are in an out-of- home placement or are at risk of being placed in out-of-home care as a result of a parent's or caretaker's substance abuse. In 2017, CB awarded grants to a fourth cohort of 17 grantees and in 2018 they plan to award 10 grants to a fifth cohort. The RPG cross-site evaluation will extend our understanding of what types of programs and services grantees provided to participants, how grantees leveraged their partnerships to coordinate services for children and families, and what the outcomes were for children and families enrolled in RPG programs. First, the cross-site evaluation will describe the characteristics of participants served by RPG programs, the types of services provided to families, the dosage of each type of service received by families, and the level of participant engagement with the services provided. Second, the [[Page 64129]] cross-site will assess the coordination of partners' service systems (e.g., shared participant data, joint staff training) to better understand how partners' collaborative effort affects the array of services offered to families. The cross-site evaluation will also focus more deeply on the partnership between the child welfare and substance use disorder (SUD) treatment agencies, to add to the research base about how these agencies can collaborate to address the needs of children and families affected by SUD. Finally, the evaluation will assess the outcomes of children and adults served through the RPG program. The evaluation is being undertaken by the Children's Bureau and its contractor Mathematica Policy Research. The evaluation is being implemented by Mathematica Policy Research and its subcontractor, WRMA Inc. The RPG Cross-Site Evaluation will include the following data collection activities: 1. Site visits and key informant interviews. The cross-site evaluation team will visit up to 21 sites to better understand the partnership and coordination between the child welfare and SUD treatment agencies. The remaining six grantees will participate in telephone interviews to gather similar information about their design and implementation. The site visits and phone interviews will focus on the RPG planning process; how and why particular services were selected; the ability of the child welfare, substance use disorder treatment, and other service systems to collaborate and support quality implementation of the RPG services; challenges experienced; and the potential for sustaining the collaborations and services after RPG funding ends. 2. Partner survey. To describe the interagency collaboration within RPG sites, grantees and their partners will participate in an online survey once during the grant period. One person from each organization knowledgeable about the RPG program will be invited to participate in the survey. The survey will collect information about communication and service coordination among partners. The survey will also collect information on characteristics of strong partnerships (e.g., data sharing agreements, colocation of staff, referral procedures, and cross-staff training). 3. Semi-annual progress reports. The semi-annual progress reports will be used to obtain updated information from grantee project directors about their program operations and partnerships, including any changes from prior periods. The CB has tailored the semi-annual progress reports to collect information on grantees' programs and other services grantees implement, the target population for the RPG program, and grantees' perceived successes and challenges to implementation. 4. Enrollment, client, and service data. To document participant characteristics and their enrollment in RPG services, all grantees will provide data on family characteristics, and enrollment of and services provided to RPG families. These data include demographic information on family members, dates of entry into and exit from RPG services, and information on RPG service dosage. These data will be submitted on an ongoing basis by staff at the grantee organizations into an information system developed by the cross-site evaluation team. 5. Outcome and impact data. To measure participant outcomes, all grantees will collect self-administered standardized instruments from RPG adults. The standardized instruments used in RPG collect information on child well-being, adult and family functioning, and adult substance use. Grantees will share the responses on these self- report instruments with the cross-site evaluation team. Grantees will also obtain administrative data on a common set of child welfare and substance use disorder treatment data elements. In addition to conducting local evaluations and participating in the RPG Cross-Site Evaluation, the RPG grantees are legislatively required to report performance indicators aligned with their proposed program strategies and activities. A key strategy of the RPG Cross-Site Evaluation is to minimize burden on the grantees by ensuring that the cross-site evaluation, which includes all grantees in a study that collects data to report on implementation, the partnerships, and participant characteristics and outcomes, fully meets the need for performance reporting. Thus, rather than collecting separate evaluation and performance indicator data, the grantees need only participate in the cross-site evaluation. In addition, using the standardized instruments that the Children's Bureau has specified will ensure that grantees have valid and reliable data on child and family outcomes for their local evaluations. The inclusion of an impact study conducted on a subset of grantees with rigorous designs will also provide the Children's Bureau, Congress, grantees, providers, and researchers with information about the effectiveness of RPG programs. A 60-Day Federal Register Notice was published for this study on October 10, 2018. This 30-Day Federal Register Notice covers the following data collection activities: (1) The site visits with grantees; (2) the web-based survey of grantee partners (3) the semi- annual progress reports; (4) enrollment and service data provided by grantees; and (6) outcome and impact data provided by grantees. Respondents. Respondents include grantee staff or contractors (such as local evaluators) and partner staff. Specific types of respondents and the expected number per data collection effort are noted in the burden table below. Annual burden estimates. The following instruments are proposed for public comment under this 30-Day Federal Register Notice. Burden for all components is annualized over three years. RPG Cross-Site Evaluation Annualized Burden Estimates ---------------------------------------------------------------------------------------------------------------- Number of Average burden Total number responses per hours per Estimated Total annual Data collection activity of respondents respondent response (in total burden burden hours (each year) hours) hours ---------------------------------------------------------------------------------------------------------------- Site Visit and Key Informant Data Collection ---------------------------------------------------------------------------------------------------------------- Program director in-person 21 .33 2 42 14 interview...................... Program manager/supervisor in- 21 .33 1 21 7 person interview............... Partner representative 63 .33 1 63 21 interviews..................... Frontline staff interview....... 42 .33 1 42 14 Program director/manager phone 12 .33 1 4.0 12 interview...................... [[Page 64130]] Partner survey.................. 135 .33 0.42 56.3 18.8 ---------------------------------------------------------------------------------------------------------------- Enrollment, client and service data ---------------------------------------------------------------------------------------------------------------- Semi-annual progress reports.... 27 2 16.5 2,673 891 Case enrollment data............ 81 43 0.25 2,612.3 870.8 Case closure.................... 81 43 0.017 174.2 58.1 Case closure--prenatal.......... 81 33 0.017 133.7 44.6 Service log entries............. 162 2,288 0.03 37,065 12,355 ---------------------------------------------------------------------------------------------------------------- Outcome and impact data ---------------------------------------------------------------------------------------------------------------- Administrative Data: Obtain access to 27 1 42.6 3,450.6 1150.2 administrative data........ Report administrative data.. 27 2 144 23,328 7,776 Standardized instruments: Review and adopt reporting 27 .33 8 216 72 templates.................. Data entry for standardized 27 130 1.25 13,162.5 4,387.5 instruments................ Review records and submit... 27 2 25 4,050 1,350 Data entry for comparison 22 130 1.25 10,725 3,575 study sites (22 grantees).. ------------------------------------------------------------------------------- Estimated Total Burden Hours .............. .............. .............. 97,827 32,609 ---------------------------------------------------------------------------------------------------------------- Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2018-27041 Filed 12-12-18; 8:45 am] BILLING CODE 4184-01-P
![64128 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
DEPARTMENT OF DEFENSE A. Purpose DEPARTMENT OF HEALTH AND
HUMAN SERVICES
GENERAL SERVICES Per Federal Acquisition Regulation
ADMINISTRATION Part 48, value engineering is the Administration for Children and
technique by which contractors (1) Families
NATIONAL AERONAUTICS AND voluntarily suggest methods for
SPACE ADMINISTRATION performing more economically and Submission for OMB Review;
share in any resulting savings, or (2) are Comment Request
[OMB Control No. 9000–0027; Docket No.
required to establish a program to
identify and submit to the Government Title: Regional Partnership Grant
2018–0003; Sequence No. 25] National Cross-Site Evaluation and
methods for performing more
economically. These recommendations Evaluation Technical Assistance.
Information Collection; Value OMB No.: 0970–NEW.
Engineering Requirements are submitted to the Government as
Description: The Children’s Bureau
value engineering change proposals
AGENCY: Department of Defense (DOD), (CB) within the Administration for
(VECP’s) and they must include specific
General Services Administration (GSA), Children and Families of the U.S.
information. This information is needed
and National Aeronautics and Space Department of Health and Human
to enable the Government to evaluate
Administration (NASA). Services seeks approval to collect
the VECP and, if accepted, to arrange for
ACTION: Notice and request for
information for the Regional Partnership
an equitable sharing plan.
comments. Grants to Increase the Well-being of and
B. Annual Reporting Burden to Improve Permanency Outcomes for
SUMMARY: Under the provisions of the Children Affected by Substance Abuse
Paperwork Reduction Act and the Office Respondents: 794. (known as the Regional Partnership
of Management and Budget (OMB) Responses per Respondent: 2. Grants Program or ‘‘RPG’’) Cross-Site
regulations, the Federal Acquisition Annual Responses: 1,588. Evaluation and Evaluation-Related
Regulation (FAR) Council invites the Technical Assistance project. The Child
Hours per Response: 15. and Family Services Improvement and
public to comment on a renewal of an
approved information collection Total Burden Hours: 23,820. Innovation Act (Pub. L. 112–34)
requirement concerning value Affected Public: Business or other for- includes a targeted grants program
engineering requirements. profit entities. (section 437(f) of the Social Security
DATES: Submit comments on or before
Act) that directs the Secretary of Health
Reporting Frequency: On occasion. and Human Services to reserve a
February 11, 2019.
C. Public Comments specified portion of the appropriation
ADDRESSES: The FAR Council invites
for these Regional Partnership Grants, to
interested persons to submit comments Public comments are particularly be used to improve the well-being of
on this information collection by any of invited on: Whether this collection of children affected by substance abuse.
the following methods: information is necessary; whether it will Under three prior rounds of RPG, the
• Federal eRulemaking Portal: This have practical utility; whether our Children’s Bureau has issued 74 grants
website provides the ability to type estimate of the public burden of this to organizations such as child welfare or
short comments directly into the collection of information is accurate, substance abuse treatment providers or
comment field or attach a file for and based on valid assumptions and family court systems to develop
lengthier comments. Go to http:// methodology; ways to enhance the interagency collaborations and
www.regulations.gov and follow the quality, utility, and clarity of the integration of programs, activities, and
instructions on the site. information to be collected; and ways in services designed to increase well-being,
• Mail: General Services which we can minimize the burden of improve permanency, and enhance the
Administration, Regulatory Secretariat the collection of information on those safety of children who are in an out-of-
Division (MVCB), 1800 F Street NW, who are to respond, through the use of home placement or are at risk of being
Washington, DC 20405. ATTN: Ms. appropriate technological collection placed in out-of-home care as a result of
Mandell/IC 9000–0027, Value techniques or other forms of information a parent’s or caretaker’s substance
Engineering Requirements. technology. abuse. In 2017, CB awarded grants to a
Instructions: All items submitted fourth cohort of 17 grantees and in 2018
must cite ‘‘Information Collection 9000– Obtaining Copies of Proposals:
Requesters may obtain a copy of the they plan to award 10 grants to a fifth
0027, Value Engineering Requirements.’’ cohort.
Comments received generally will be information collection documents from
the General Services Administration, The RPG cross-site evaluation will
posted without change to http:// extend our understanding of what types
www.regulations.gov, including any Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC of programs and services grantees
personal and/or business confidential provided to participants, how grantees
information provided. To confirm 20405, telephone 202–501–4755.
leveraged their partnerships to
receipt of your comment(s), please Please cite OMB Control No. 9000– coordinate services for children and
check www.regulations.gov, 0027, Value Engineering Requirements, families, and what the outcomes were
approximately two to three days after in all correspondence. for children and families enrolled in
submission to verify posting (except Dated: December 10, 2018. RPG programs. First, the cross-site
amozie on DSK3GDR082PROD with NOTICES1
allow 30 days for posting of comments Janet Fry, evaluation will describe the
submitted by mail). characteristics of participants served by
Director, Federal Acquisition Policy Division,
FOR FURTHER INFORMATION CONTACT: Ms. Office of Governmentwide Acquisition Policy, RPG programs, the types of services
Marilyn E. Chambers, Procurement Office of Acquisition Policy, Office of provided to families, the dosage of each
Analyst, 202–285–7380, or Governmentwide Policy. type of service received by families, and
marilyn.chambers@gsa.gov. [FR Doc. 2018–27019 Filed 12–12–18; 8:45 am] the level of participant engagement with
SUPPLEMENTARY INFORMATION: BILLING CODE 6820–EP–P the services provided. Second, the
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![64130 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
RPG CROSS-SITE EVALUATION ANNUALIZED BURDEN ESTIMATES—Continued
Number of Average
Total number responses per burden hours Estimated total Total annual
Data collection activity of respondents respondent per response burden hours burden hours
(each year) (in hours)
Partner survey ...................................................................... 135 .33 0.42 56.3 18.8
Enrollment, client and service data
Semi-annual progress reports ............................................. 27 2 16.5 2,673 891
Case enrollment data ........................................................... 81 43 0.25 2,612.3 870.8
Case closure ........................................................................ 81 43 0.017 174.2 58.1
Case closure—prenatal ....................................................... 81 33 0.017 133.7 44.6
Service log entries ............................................................... 162 2,288 0.03 37,065 12,355
Outcome and impact data
Administrative Data:
Obtain access to administrative data ........................... 27 1 42.6 3,450.6 1150.2
Report administrative data ............................................ 27 2 144 23,328 7,776
Standardized instruments:
Review and adopt reporting templates ......................... 27 .33 8 216 72
Data entry for standardized instruments ...................... 27 130 1.25 13,162.5 4,387.5
Review records and submit .......................................... 27 2 25 4,050 1,350
Data entry for comparison study sites (22 grantees) ... 22 130 1.25 10,725 3,575
Estimated Total Burden Hours ..................................... ........................ ........................ ........................ 97,827 32,609
Additional Information: Copies of the DEPARTMENT OF HEALTH AND Restoration Act of 1984 (Pub. L. 98–417)
proposed collection may be obtained by HUMAN SERVICES (the 1984 amendments), which
writing to the Administration for authorized the approval of duplicate
Children and Families, Office of Food and Drug Administration versions of drug products under an
Planning, Research and Evaluation, 330 [Docket No. FDA–2018–P–1734]
ANDA procedure. ANDA applicants
C Street SW, Washington, DC 20201. must, with certain exceptions, show that
Attention Reports Clearance Officer. All Determination That IC–GREEN the drug for which they are seeking
requests should be identified by the title (Indocyanine Green for Injection), 10 approval contains the same active
of the information collection. Email Milligrams/Vial, 40 Milligrams/Vial, and ingredient in the same strength and
address: infocollection@acf.hhs.gov. 50 Milligrams/Vial Were Not Withdrawn dosage form as the ‘‘listed drug,’’ which
From Sale for Reasons of Safety or is a version of the drug that was
OMB Comment: OMB is required to previously approved. ANDA applicants
Effectiveness
make a decision concerning the do not have to repeat the extensive
collection of information between 30 AGENCY: Food and Drug Administration, clinical testing otherwise necessary to
and 60 days after publication of this HHS. gain approval of a new drug application
document in the Federal Register. ACTION: Notice. (NDA).
Therefore, a comment is best assured of The 1984 amendments include what
having its full effect if OMB receives it SUMMARY: The Food and Drug is now section 505(j)(7) of the Federal
within 30 days of publication. Written Administration (FDA or Agency) has Food, Drug, and Cosmetic Act (21 U.S.C.
comments and recommendations for the determined that IC–GREEN 355(j)(7)), which requires FDA to
proposed information collection should (indocyanine green for injection), 10 publish a list of all approved drugs.
be sent directly to the following: Office milligrams (mg)/vial, 40 mg/vial, and 50 FDA publishes this list as part of the
of Management and Budget, Paperwork mg/vial, was not withdrawn from sale ‘‘Approved Drug Products with
Reduction Project, Email: OIRA_ for reasons of safety or effectiveness. Therapeutic Equivalence Evaluations,’’
This determination will allow FDA to which is known generally as the
SUBMISSION@OMB.EOP.GOV, Attn:
approve abbreviated new drug ‘‘Orange Book.’’ Under FDA regulations,
Desk Officer for the Administration for
applications (ANDAs) for indocyanine drugs are removed from the list if the
Children and Families.
green for injection, 10 mg/vial, 40 mg/ Agency withdraws or suspends
Robert Sargis, vial, and 50 mg/vial if all other legal and approval of the drug’s NDA or ANDA
Reports Clearance Officer. regulatory requirements are met. for reasons of safety or effectiveness or
[FR Doc. 2018–27041 Filed 12–12–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: if FDA determines that the listed drug
BILLING CODE 4184–01–P
Heather A. Dorsey, Center for Drug was withdrawn from sale for reasons of
Evaluation and Research, Food and safety or effectiveness (21 CFR 314.162).
amozie on DSK3GDR082PROD with NOTICES1
Drug Administration, 10903 New A person may petition the Agency to
Hampshire Ave., Bldg. 51, Rm. 6219, determine, or the Agency may
Silver Spring, MD 20993–0002, 301– determine on its own initiative, whether
796–3601. a listed drug was withdrawn from sale
SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness.
Congress enacted the Drug Price This determination may be made at any
Competition and Patent Term time after the drug has been withdrawn
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Document Created: 2018-12-13 01:16:03
Document Modified: 2018-12-13 01:16:03
| 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 | 83 FR 64128 |
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