Medicare & Medicaid Services, shall make publicly avail-
able, on the website of the Centers for Disease Control 
and Prevention, pregnancy and postpartum data collected 
across all surveillance systems relating to COVID–19, 
disaggregated by race, ethnicity, State, and Tribal location 
including the following: 
(1) Data related to all COVID–19 diagnostic 
testing, including the number of pregnant people 
and postpartum people tested and the number of 
positive cases. 
(2) Data related to all suspected cases of 
COVID–19 in pregnant, birthing, and postpartum 
people who did not undergo testing. 
(3) Data related to all COVID–19 serologic 
testing, including the number of pregnant and 
postpartum people tested and the number of such 
serologic tests that were positive. 
(4) Data related to treatment for COVID–19, 
including hospitalizations, emergency room, and in-
tensive care unit admissions of pregnant, birthing, 
and postpartum people related to COVID–19. 
(5) Data related to COVID–19 outcomes, in-
cluding total fatalities and case fatality (expressed 
as the proportion of people who were infected with 
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COVID–19 and died from the virus) of pregnant 
and postpartum people. 
(6) Data related to pregnancy and infant health 
outcomes for pregnant people with confirmed or sus-
pected COVID–19, which may include stillbirths, 
maternal mortality and morbidity, infant mortality, 
preterm births, low-birth weight infants, and cesar-
ean section births. 
(b) TIMELINE.—The Secretary shall update the data 
made available under this section not less frequently than 
monthly, during the COVID–19 public health emergency 
and for at least one month after the end of the COVID– 
19 public health emergency. 
(c) PRIVACY.—In publishing data under this section, 
the Secretary shall take all necessary steps to protect the 
privacy of people whose information is included in such 
data, including by complying with— 
(1) privacy protections under the regulations 
promulgated under section 264(c) of the Health In-
surance Portability and Accountability Act of 1996 
(42 U.S.C. 1320d–2 note); and 
(2) protections from all inappropriate internal 
use by an entity that collects, stores, or receives the 
data, including use of such data in determinations of 
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eligibility (or continued eligibility) in health plans, 
and from inappropriate uses. 
(d) INDIAN HEALTH SERVICE.—The Director of the 
Indian Health Service and Director of the Centers for Dis-
ease Control and Prevention shall consult with Indian 
Tribes and confer with urban Indian organizations on data 
collection and reporting for purposes of this section. 
(e) DATA COLLECTION GUIDANCE.—The Secretary 
shall issue guidance to States and local public health de-
partments to ensure that all relevant demographic data, 
including pregnancy and postpartum status, are collected 
and included when sending COVID–19 testing specimen 
to laboratories, and State and local health departments 
and Indian Tribes are disaggregating data on COVID–19 
status in data on maternal and infant morbidity and mor-
tality. The Secretary shall ensure that the guidance is de-
veloped in consultation with Indian Tribes to ensure that 
it includes tribally developed best practices on reducing 
misclassification of American Indian and Alaska Native 
people in Federal, State, and local public health surveil-
lance systems. 
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SEC. 6. INCLUSION OF PREGNANT PEOPLE AND LACTATING 
PEOPLE IN VACCINE AND THERAPEUTIC DE-
VELOPMENT FOR COVID–19. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health shall— 
(1) support and advance the responsible inclu-
sion of pregnant and lactating people in COVID–19 
therapeutic and vaccine clinical trials when safe and 
appropriate; 
(2) prioritize the implementation of final rec-
ommendations made by the Task Force on Research 
Specific to Pregnant Women and Lactating Women 
to improve the inclusion of pregnant and lactating 
people in clinical research when safe and appro-
priate, particularly as these recommendations apply 
to the development and issuance of safe and effective 
COVID–19 therapeutics and vaccines; and 
(3) ensure that at least one COVID–19 vaccine 
developed and made available for use in the United 
States is suitable for pregnant people and lactating 
people. 
(b) REQUIREMENTS.— 
(1) REPORTING REQUIREMENTS.—The Director 
of the National Institutes of Health shall collect in-
formation from every developer of a drug or biologi-
cal product for the treatment or prevention of 
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COVID–19 in the clinical stages of development that 
received Federal funding from the Department of 
Health and Human Services and its subagencies re-
garding— 
(A) how evidence is being generated to 
evaluate the safety, efficacy, and appropriate 
dosing of the drug or biological product among 
pregnant people and lactating people; 
(B) plans for the systematic collection of 
data from people who are inadvertently exposed 
to the drug or biological product while pregnant 
or lactating; 
(C) plans for the inclusion of pregnant 
people and lactating people, including racial and 
ethnic minorities disproportionately affected by 
COVID–19, in clinical trials or the rationale for 
exclusion; and 
(D) plans for performing Developmental 
and Reproductive Toxicology studies, or the ra-
tionale for not performing such studies. 
(2) DRUG APPROVALS AND BIOLOGICAL PROD-
UCT LICENSING.—The Commissioner of Food and 
Drugs shall require a drug or biological product de-
veloper submit, as part of an application for ap-
proval of a drug under section 505 of the Federal 
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