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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


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

GENERAL INFORMATION

Committee NameTask Force on Research Specific to Pregnant Women and Lactating WomenAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number2603
Original Establishment Date3/13/2017Committee StatusChartered
Actual Termination Date Committee URLhttps://www.nichd.nih.gov/about/advisory/PRGLAC...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*28
Current Charter Date3/13/2019Designated Fed Officer Position Title*Director, Office of Legislation and Public Policy
Date Of Renewal Charter3/13/2021Designated Federal Officer PrefixMs.
Projected Termination Date3/13/2021Designated Federal Officer First Name*Lisa
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Kaeser
Establishment Authority*Statutory (Congress Created)Designated Federal Officer SuffixJ.D.
Specific Establishment Authority*Section 2041 of the 21st Century Cures Act, P.L. 114-255Designated Federal Officer Phone*301-496-0536
Effective Date Of Authority*12/13/2016Designated Federal Officer Fax*
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*kaeserl@mail.nih.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
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 is composed of both Federal and non-Federal members. In this reporting period, the committee includes 16 federal members and 10 non-federal members.
How frequent & relevant are cmte mtgs?*Meetings of the full Task Force are held not less than two times each year or more frequently, as appropriate, to fulfill its duties. During this reporting period, the full committee met in-person (February 2020) and via Webinar (June 2020); working groups of PRGLAC each met five times via webinar.
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 RemarksThe DFO and Decision Maker are the same person based on the assignment of duties within the Center.

Task Force Members: Ms. Tschetter resigned on 10/21/2019 and Dr. Foley resigned on 1/15/2020.

Special Government Employees (SGE) members do not receive honoraria for service on this committee.

Daily salary costs have been estimated for Federal members of this committee. The dollar figure represents a portion of their annual salary. No funds have been transferred between the committee and the agency. No additional funds are paid to Federal employees due to membership on this committee.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*No
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryYesAction OtherNo
Outcome Increased Customer SatisfactionNoAction CommentAll of the above actions are possible; depends on the responses from the Secretary, from Congress, and internally to the guidance provided by PRGLAC in the upcoming implementation plan.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentOutcome Major Policy Changes: The Secretary extended PRGLAC’s charter for two years in March 2019, requesting that the Task Force provide guidance on implementing the recommendations made in the plan.

Outcome Improved Service Delivery: Improved information relevant to therapeutics used by pregnant women and lactating women; depends on implementation of report.
Number Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentNot ApplicableGrants Review CommentNot Applicable
Number Of Recommendations*125Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe 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 WebsiteYes
% of Recs Fully Implemented*7.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe 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 WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsNo
% of Recs Partially Implemented CommentThe implementation plan will provide guidance to the HHS Secretary about what steps are needed to carry out the remaining recommendations.Access OtherNo
Agency Feedback*YesAccess CommentIC 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 reviews 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, which resulted in a report to the HHS Secretary and to Congress, includes 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 is creating an implementation plan for the recommendations listed in the report.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$0.00Est Payments to Non-Fed Members Next FY*$0.00
Payments to Federal Members*$18,987.00Est. Payments to Fed Members Next FY*$18,987.00
Payments to Federal Staff*$135,648.00Estimated Payments to Federal Staff*$100,198.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$5,351.00Est Travel Reimb Non-Fed Members nextFY*$5,390.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$10,042.00Est. Other Costs Next FY*$10,143.00
Total Costs$170,028.00Est. Total Next FY*$134,718.00
Federal Staff Support (FTE)*0.60Est. Fed Staff Support Next FY*0.40
Cost RemarksActual costs lower than projected in FY19. Some meetings held virtually instead of in-person in response to COVID-19 pandemic.Est Cost RemarksIt is not anticipated that the Task Force will meet again. Costs are projected only if the Chair and other Federal members/federal staff are required to prepare and briefings.
Hide Section - Interest Areas

Interest Areas

Category
Area
Civil Rights
Children
Women
Government
Federal Government
Health
Nutrition
Nutrition for Women, Infants and Children
Research
Basic Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-036537Task Force on Research Specific to Pregnant Women and Lactating Women2019
 COM-034749Task Force on Research Specific to Pregnant Women and Lactating Women2018
 COM-001962Task Force on Research Specific to Pregnant Women and Lactating Women2017