[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35099-35100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information: Inviting Comments To Inform the Women's 
Health Consensus Conference (WHCC)

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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SUMMARY: The National Institutes of Health (NIH) Office of Research on 
Women's Health (ORWH) is planning a Women's Health Consensus Conference 
(WHCC) in October 2021, in response to a Congressional request to 
address NIH research efforts related to women's health research as well 
as the following specific conditions, rising maternal morbidity and 
mortality rates, increasing rates of chronic debilitating conditions in 
women, and stagnant cervical cancer survival rates. The ORWH is seeking 
comments and testimonies from the extramural scientific community, 
professional societies, and the general public regarding the topics 
mentioned above to assist with identifying research gaps, pitfalls in 
clinical practices, and obtaining real-life testimonial experiences 
(direct or indirect) caused by any or all of the listed public health 
issues.

DATES: The Women's Health Consensus Conference (WHCC) Request for 
Information is open for public comment through September 15, 2021. 
Comments must be received by September 15, 2021, to ensure 
consideration. Comments received after the public comment period has 
closed may be considered by the Office of Research on Women's Health.

ADDRESSES: Submissions must be sent electronically to Elizabeth Barr, 
Ph.D., <a href="/cdn-cgi/l/email-protection#792e313a3a39161d57171011571e160f"><span class="__cf_email__" data-cfemail="faadb2b9b9ba959ed4949392d49d958c">[email protected]</span></a>.

FOR FURTHER INFORMATION CONTACT: Questions about this request for 
information should be directed to Elizabeth Barr, Ph.D., Office of 
Research on Women's Health, 6707 Democracy Boulevard, Suite 400, 
Bethesda, MD 20817, <a href="/cdn-cgi/l/email-protection#9dcad5dededdf2f9b3f3f4f5b3faf2eb"><span class="__cf_email__" data-cfemail="04534c4747446b602a6a6d6c2a636b72">[email protected]</span></a>, 301-402-7895.

SUPPLEMENTARY INFORMATION: ORWH was established at NIH on September 10, 
1990. The Office was reaffirmed by statute in congressional legislation 
by the NIH Revitalization Act of 1993 (Pub. L. 103-43, Section 486) to 
serve as the focal point for women's health research at NIH, reporting 
directly to the NIH Director, and working in a collaborative 
partnership with the Institutes, Centers, and Offices. ORWH is 
convening the Women's Health Consensus Conference in response to 
significant items (SI) in H.R. 7614--Departments of Labor, Health and 
Human Services, and Education, and Related Agencies Appropriations Act 
(2021). The SIs require that a consensus forum assessing research on 
the health of women be held by the fall of 2021.
    Goals and Requirements. Both the House and Senate directed NIH to 
evaluate research underway related to women's health and provide an 
update on priority areas for additional study to advance women's health 
research, including reproductive sciences. In preparation for the WHCC, 
ORWH, and partners from other NIH Institutes, Centers, and Offices will 
assess the current state of NIH-supported women's health research; 
delineate research gaps and, in turn, opportunities related to research 
on the health of women; and set contemporary priorities for research on 
the health of women. The following specific topics, among others, will 
be addressed: Maternal morbidity and mortality,<SUP>1 2</SUP> the 
rising rates of chronic debilitating conditions in women \3\ and 
stagnant cervical cancer survival rates.\4\ To inform the WHCC meeting 
and discussion, ORWH seeks comment and testimony on current research 
efforts on the health of women.

1. Maternal Morbidity and Mortality

    Birthing people in the United States are dying during the postnatal 
period from conditions that can be treated, such as cardiovascular 
disease, hypertension, thrombotic pulmonary embolism, and hemorrhage, 
among others. An estimated six in ten maternal deaths are 
preventable.\5\ The public health challenge is to reduce U.S. maternal 
mortality rates (17.2 per 100,000 live births in 2011-15) \6\ to be 
comparable with or lower than other first world countries such as 
United Kingdom, Germany, France, and Canada (rates all below 9.2 per 
100,000 live births in 2015).\7\
    Individual, behavioral, and structural factors influence incidence 
of maternal morbidity and mortality.\5\ Structural racism,\5\ implicit 
bias,\6\ & racially biased policies and practices \7\ contribute to 
significant and persistent racial disparities in maternal morbidity and 
mortality. From 2011-2015 non-Hispanic Black and American Indian/Alaska 
Native women had the highest incidences of pregnancy-related deaths. 
Black women are three times more likely to die from a pregnancy-related 
cause than White women,\6\ in New York City, Black women are twelve 
times more likely than White women to die from pregnancy-related 
causes.\8\ Similar racial disparities exist in maternal morbidity.\9\ 
Neither education nor higher socioeconomic status mitigates the 
elevated risks of severe maternal morbidity and maternal mortality 
among Black women.

2. Chronic Debilitating Conditions in Women

    Chronic Debilitating Conditions include diseases that occur in both 
men and women such as diabetes, cardiovascular disease, cancer, and 
autoimmune diseases as well as sex-specific conditions such as fibroids 
and endometriosis. In the United States, six in ten adults have a 
chronic disease; chronic disease is the leading cause of death and 
disabilities.\10\
    Rates of many chronic diseases in women are rising, for example 
COPD in women,\11\ and new discoveries related to sex-difference and 
molecular mechanisms of disease are being published every day.\12\ 
Biomedical and socio-behavioral understandings of sex

[[Page 35100]]

and gender influences on mechanisms and outcomes of chronic diseases 
are incomplete, reducing the specificity, sensitivity, and efficacy of 
diagnostic tests and treatments for women. Research on rare diseases 
that are more prevalent in women or only occur in women faces similar 
challenges.

3. Stagnant Cervical Cancer Survival Rates

    In the United States it is estimated approximately 12,000 new cases 
of cervical cancer occur each year. Human papillomavirus (HPV) is the 
cause of cervical cancer as well as a large percentage of cancers of 
the vulva, vagina, penis, anus, rectum, and oropharynx.\13\ Despite 
cancer prevention efforts through HPV vaccination and cervical cancer 
screening, incidence and mortality from this malignancy have been 
stable for the last two decades. Communities historically under-
represented in medicine are disproportionately burdened by this 
disease. The incidence rate of cervical cancer is 30 percent higher in 
Black women \14\ and Black women persistently present at later stages 
at diagnosis.\15\ The overall 5-year relative survival rate for 
cervical cancer among Black women is 56 percent, compared with 68 
percent among White women.\14\

Information Requested

    This Request for Information (RFI) invites the scientific 
community, health professionals, professional societies, and the 
general public to provide comments and testimonies on research gaps, 
pitfalls in clinical practices, and obtaining real-life testimonial 
experiences (direct or indirect) related to any or all of the listed 
public health issues. Responses are welcome from associations and 
professional organizations as well as individuals.
    This RFI is for planning purposes only and should not be construed 
as a solicitation or an obligation on the federal government, the 
National Institutes of Health, or individual NIH Institutes or Centers. 
Responses to this RFI Notice are voluntary. The NIH will use the 
information submitted in response to this RFI at its discretion. NIH 
will analyze the information submitted and may share it internally or 
in reports. The information may or may not be reflected in future 
solicitations, as appropriate and at the government's discretion. NIH 
advises respondents the government is under no obligation to 
acknowledge receipt of the information provided and will not provide 
feedback to respondents. The federal government will not pay for the 
preparation of any information submitted or for the government's use. 
NIH will not consider submitted information confidential. Additionally, 
the government cannot guarantee the confidentiality of the information 
provided.

References

1. Hoyert DL. Maternal Mortality Rates in the United States, 2019. 
NCHS Health E-Stats. 2021.
2. Collier AY, Molina RL. Maternal Mortality in the United States: 
Updates on Trends, Causes, and Solutions. Neoreviews. 
2019;20(10):e561-e574.
3. Raghupathi W, Raghupathi V. An Empirical Study of Chronic 
Diseases in the United States: A Visual Analytics Approach. Int J 
Environ Res Public Health. 2018;15(3).
4. Gaffney DK, Hashibe M, Kepka D, Maurer KA, Werner TL. Too many 
women are dying from cervix cancer: Problems and solutions. Gynecol 
Oncol. 2018;151(3):547-554.
5. National Institutes of Health, Office of Research on Women's 
Health. Maternal Morbidity and Mortality What do we Know? How are we 
Addressing it? 20-OD-80692020:1-16.
6. Petersen EE DN, Goodman D, et al. Vital Signs: Pregnancy-Related 
Deaths, United States, 2011-2015, and Strategies for Prevention, 13 
States, 2013-2017. MMWR Morb Mortal Wkly Rep 2019(68):423-429.
7. GDB 2015 Maternal Mortality Collaborators. Global, regional, and 
national levels of maternal mortality, 1990-2015: A systematic 
analysis for the Global Burden of Disease Study 2015. Lancet. 
2016;388(10053):1775-1812.
8. New York City Department of Health and Mental Hygiene Bureau of 
Maternal, Infant, and Reproductive Health. Pregnancy-Associated 
Mortality, New York City, 2006-2010.
9. Howell EA, Egorova NN, Balbierz A, Zeitlin J, Hebert PL. Site of 
delivery contribution to black-white severe maternal morbidity 
disparity. American Journal of Obstetrics and Gynecology. 
2016;215(2):143-152.
10. National Center for Chronic Disease Prevention and Health 
Promotion. Chronic Diseases in America. https://www.cdc.gov/chronicdisease/resources/infographic/chronic-diseases.htm. Updated 
1/12/2021.
11. Bade BC, DeRycke EC, Ramsey C, et al. Sex Differences in 
Veterans Admitted to the Hospital for Chronic Obstructive Pulmonary 
Disease Exacerbation. Ann Am Thorac Soc. 2019;16(6):707-714.
12. De Bellis A, De Angelis G, Fabris E, Cannata A, Merlo M, Sinagra 
G. Gender-related differences in heart failure: Beyond the ``one-
size-fits-all'' paradigm. Heart Fail Rev. 2020;25(2):245-255.
13. Viens LJ HS, Watson M, et al. Human Papillomavirus-Associated 
Cancers--United States, 2008-2012. Weekly 2016(65):661-666.
14. DeSantis CE, Miller KD, Goding Sauer A, Jemal A, Siegel RL. 
Cancer statistics for African Americans, 2019. CA Cancer J Clin. 
2019;69(3):211-233.
15. Benard VB, Watson M, Saraiya M, et al. Cervical cancer survival 
in the United States by race and stage (2001-2009): Findings from 
the CONCORD-2 study. Cancer. 2017;123 Suppl 24(Suppl 24):5119-5137.

    Dated: June 25, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-14151 Filed 6-30-21; 8:45 am]
BILLING CODE 4140-01-P


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