Request for Information: Inviting Comments To Inform the Women's Health Consensus Conference (WHCC), 35099-35100 [2021-14151]

Download as PDF Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices such as general perceptions of risk, the adoption of risk reduction behaviors, and perceptions framed by scientific controversy or misinformation. The following statements are provided to obtain feedback to fill existing gaps in DW CEC knowledge and practice in these research areas. Please comment on: 1. The critical, impactful research questions and topics that should be addressed in order to better protect American public health in regard to DW CEC. 2. Research priorities within each of the four areas described below. 3. New or innovative tools, technologies, software, modeling, methods, data/information sharing, etc. that should be developed or employed to address these research areas. This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals, or as an obligation in any way on the part of the United States Federal government. The Federal government will not pay for the preparation of any information submitted or for the government’s use. Additionally, the government cannot guarantee the confidentiality of the information provided. Dated: June 28, 2021. Christopher P. Weis, Toxicology Liaison, National Institute of Environmental Health Sciences, National Institutes of Health. [FR Doc. 2021–14150 Filed 6–30–21; 8:45 am] BILLING CODE 4140–01–P 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. 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 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., WHCC@od.nih.gov. 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, WHCC@od.nih.gov, 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 35099 addressed: Maternal morbidity and mortality,1 2 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 nonHispanic 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 sexspecific 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 E:\FR\FM\01JYN1.SGM 01JYN1 35100 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 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. khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 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 EStats. 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. Genderrelated 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: David Yang at 240–695–6406 or yangp3@mail.nih.gov. Licensing information may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496– 2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: SUMMARY: Pre-Biotic Formulation of Topical Chemicals for Use on Human Skin Description of Technology: Atopic dermatitis (AD) is a common, recurrent, chronic inflammatory skin disease that is a cause of considerable economic and social burden. It is one of the most prevalent skin disorders, affecting ∼25% of children in developed and developing countries and is expected to continue to escalate. This increased rate of incidence has changed the focus of research on AD toward epidemiology, prevention, and treatment. E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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., [email protected].

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, [email protected], 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,1 2 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