FACACLASSIC

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HHS - 2603 - Task Force on Research Specific to Pregnant Women and Lactating Women - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Task Force on Research Specific to Pregnant Women and Lactating Women	Agency Name	Department of Health and Human Services
Fiscal Year	2021	Committee Number	2603
Original Establishment Date	3/13/2017	Committee Status	Terminated
Actual Termination Date	3/13/2021	Committee URL	https://www.nichd.nih.gov/about/advisory/PRGLAC...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	28
Terminated This FY	Yes	Designated Fed Officer Position Title*	Director, Office of Legislation, Public Policy, and Ethics
Merged This FY		Designated Federal Officer Prefix	Ms.
Current Charter Date	3/13/2019	Designated Federal Officer First Name*	Laura
Date Of Renewal Charter	3/13/2021	Designated Federal Officer Middle Name
Projected Termination Date	3/13/2021	Designated Federal Officer Last Name*	Berkson
Exempt From Renewal*	No	Designated Federal Officer Suffix	J.D.
Specific Termination Authority	Section 2041 of the 21st Century Cures Act, P.L. 114-255	Designated Federal Officer Phone*	(301) 594-2893
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*
Specific Establishment Authority*	Section 2041 of the 21st Century Cures Act, P.L. 114-255	Designated Federal Officer Email*	laura.berkson@nichd.nih.gov
Effective Date Of Authority*	12/13/2016
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Terminate
Legislation to Terminate Required	Yes
Legislation Status
How does cmte accomplish its purpose?*	The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was established under section 2041 of the 21st Century Cures Act, P.L.114-255 to provide advice and guidance to the Secretary of Department of Health and Human Services regarding Federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities. The committee prepared and submitted to the HHS Secretary and Congress a report to correspond with the legislative requirements under the 21st Century Cures Act.
How is membership balanced?*	The Task Force was composed of both Federal and non-Federal members. For FY21, the committee included 16 federal members and 8 non-federal members.
How frequent & relevant are cmte mtgs?*	The Task Force did not meet in FY 2021 and the committee terminated in March 2021. The last full Task Force meeting was held via Webinar in June 2020.
Why advice can't be obtained elsewhere?*	The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The committee is tasked with identifying these gaps and will report its findings back to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives. The quality, scope, and balance of advice from this committee cannot be obtained from NIH staff or from other established source because the membership of the committee is constituted to meet the specific requirements mandated in legislation.
Why close or partially close meetings?	Not Applicable
Recommendation Remarks	PRGLAC did not meet in FY 2021. Lisa Kaeser, J.D. retired on 12/31/2020 and was replaced by Laura Berkson, J.D. as the DFO and Decision Maker of the committee. The sunset date of the committee was March 13, 2021. All Special Government Employees (SGE), NIH-Federal and non-NIH Federal members retired on March 13, 2021. SGE members do not receive honoraria for service on this committee.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	No	Action Reallocate Resources	No
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	Yes	Action Other	No
Outcome Increased Customer Satisfaction	No	Action Comment	All of the above actions are possible; depends on the responses from the Secretary, from Congress, and internally to the guidance provided by PRGLAC implementation plan.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	Outcome Major Policy Changes: PRGLAC released an implementation plan in August 2020 to provide guidance on implementing the recommendations made in the initial report. Outcome Improved Service Delivery: Improved information relevant to therapeutics used by pregnant women and lactating women depends on implementation of the report.	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	Not Applicable	Grants Review Comment	Not Applicable
Number Of Recommendations*	125	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The implementation plan contains 110 recommendations/implementation steps for the original 15 recommendations contained in the Task Force report sent to HHS on September 13, 2018.	Access Agency Website	Yes
% of Recs Fully Implemented*	7.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The HHS Secretary extended PRGLAC’s charter for two years in March 2019, requesting additional guidance on implementation of the recommendations. This action fulfilled Recommendation 14, which advised the extension of the Task Force.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	No
% of Recs Partially Implemented Comment	The implementation plan will provide guidance to the HHS Secretary about what steps are needed to carry out the remaining recommendations.	Access Other	No
Agency Feedback*	Yes	Access Comment	IC CMO: Lisa Neal, NICHD Committee Management Officer; contact information: lisa.neal@nih.gov.
Agency Feedback Comment*	NICHD led the Task Force for the NIH. Multiple federal agencies and other input incorporated into the final recommendations/report.	Narrative Description*	NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. Currently, insufficient information exists to guide the care and treatment of pregnant women in many areas. For instance, the safety, efficacy, and dosing of medications approved for the general population may not apply to pregnant or nursing women. PRGLAC reviewed current research on pregnancy and lactation, identifying ethical issues surrounding the inclusion of pregnant women and nursing mothers in clinical research, and chronicling the federal activities that focus on therapies for pregnant women and nursing mothers. This effort, resulted in a report to the HHS Secretary and to Congress, which included a focus on specific drugs, formulations, and other pharmacological factors that may affect health outcomes for pregnant women and nursing mothers and their children. PRGLAC also created an implementation plan for the recommendations listed in the report.

COSTS

1. Payments to Non-Federal Members*	$0.00	1. Est Paymnts to Non-Fed Membrs Nxt FY*	$0.00
2. Payments to Federal Members*	$0.00	2. Est. Payments to Fed Members Next FY*	$0.00
3. Payments to Federal Staff*	$0.00	3. Estimated Payments to Federal Staff*	$0.00
4. Payments to Consultants*	$0.00	4. Est. Payments to Consultants Next FY*	$0.00
5. Travel Reimb. For Non-Federal Membrs*	$0.00	5. Est Travel Reimb Non-Fed Membr nxtFY*	$0.00
6. Travel Reimb. For Federal Members*	$0.00	6. Est Travel Reimb For Fed Members*	$0.00
7. Travel Reimb. For Federal Staff*	$0.00	7. Est. Travel Reimb to Fed Staf Nxt FY*	$0.00
8. Travel Reimb. For Consultants*	$0.00	8. Est Travel Reimb to Consltnts Nxt FY*	$0.00
10. Other Costs	$0.00	10. Est. Other Costs Next FY*	$0.00
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	8/17/2021 11:35 AM	Est. Fed Staff Support Next FY*	0.00
Federal Staff Support (FTE)*	0.00	Est Cost Remarks
Cost Remarks	No meetings were held in FY 2021.

Interest Areas

Category Area Civil Rights Children Women Government Federal Government Health Nutrition Nutrition for Women, Infants and Children Research Basic Research

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