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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

          - [Docket No. CDC-2021-0088]

# AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

# ACTION:

Notice with comment period.

# SUMMARY:

                        The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on CDC's contraception recommendations. Two guidance documents,                         *U.S. Medical Eligibility Criteria for Contraceptive Use*                         (US MEC) and                         *U.S. Selected Practice Recommendations for Contraceptive Use*                         (US SPR), provide evidence-based recommendations to assist health care providers when counseling patients on contraceptive choice and use. Updates to these guidance documents typically occur every 5 years. As part of the planning process for the next update, CDC is requesting public comment on content to consider for revision or addition to the recommendations and how to improve the implementation of the guidance documents. This action is necessary to consider multiple and diverse perspectives and ensure that the documents meet the needs of U.S. health care providers and the persons they serve.                    

# DATES:

Written comments must be received on or before October 18, 2021.

# ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0088 by any of the following methods:
      -  Federal eRulemaking Portal: http://www.regulations.gov.                          Follow the instructions for submitting comments.                    
      -  Mail:                          [insert complete mailing address, including mailstop]                    

*Instructions:*                         All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to                         *http://regulations.gov,*                         including any personal information provided. For access to the docket to read background documents or comments received, go to                         *http://www.regulations.gov.*

# FOR FURTHER INFORMATION CONTACT:

                        Kathryn M. Curtis, Ph.D., Division of Reproductive Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS S107-2, Atlanta, GA 30341. Telephone: 770-488-5200. Email:                         *usmecspr@cdc.gov.*

# SUPPLEMENTARY INFORMATION:

## Public Participation

Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. CDC invites comments specifically on the following questions:

                    1. Are there existing US MEC or US SPR recommendations that CDC should consider reviewing for possible                     *revision,*                     based on new evidence or other justification? Please provide references to new evidence and justification to support review of existing recommendations.                

2. Are there new recommendations that CDC should consider adding to the US MEC? This could include eligibility criteria for contraceptive use among people with medical conditions or characteristics not currently included in the US MEC. Please provide references to supporting evidence, justification, and impact of new recommendations.

3. Are there new recommendations that CDC should consider adding to the US SPR? This could include clinical practice recommendations to address issues regarding initiation and use of specific contraceptive methods not currently included in the US SPR. Please provide references to supporting evidence, justification, and impact of new recommendations.

4. Are there other issues that should be considered or suggestions to improve implementation of the US MEC and US SPR recommendations to help ensure equitable access to contraceptive services (such as better ways of presenting the recommendations, additional job aids or tools for providers, broader dissemination and implementation strategies, inclusion of additional partners, etc.)? Please provide references to supporting evidence or justification.

                    Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on                     *https://www.regulations.gov.*                     Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing                           ( print page 46704)                        private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted in preparation of the final document.                

In 2017-2019 in the United States, 65% of women aged 15-49 years used contraception; the most common contraceptive methods used were female sterilization, oral contraceptive pills, implants and intrauterine devices, and male condoms [1]. The majority (61%) of U.S. women aged 18-49 years have ongoing or potential need for contraceptive services [2]. Similarly, in 2010-2016, about 60% of men aged 15-44 years in the United States needed family planning [3]. Equitable access to evidence-based, high quality care is critical to meeting the needs of persons seeking contraceptive services, improving reproductive autonomy, and reducing unintended pregnancy in the United States [2].

                    Since 2010, CDC has published evidence-based recommendations on contraception provision. These recommendations are intended to assist health care providers when they counsel patients about choice and use of contraceptive methods, with the goal of reducing medical barriers to contraception access.                     *U.S. Medical Eligibility Criteria for Contraceptive Use, 2016*                     (US MEC) comprises recommendations for the use of specific contraceptive methods by persons with certain characteristics or medical conditions, such as diabetes, hypertension, and being postpartum or breastfeeding [4].                     *U.S. Selected Practice Recommendations for Contraceptive Use, 2016*                     (US SPR) addresses common, yet sometimes complex, issues regarding initiation and use of specific contraceptive methods, such as examinations or tests needed before starting a method and management of side effects [5]. Both guidance documents are adapted from global guidance developed by the World Health Organization (WHO) and are based on review of the scientific evidence and consultation with national experts. CDC partners with other federal agencies and professional organizations in the development, dissemination, and implementation of the guidance documents to improve access to contraception and quality of family planning services.                

CDC is committed to ensuring that the US MEC and US SPR recommendations are reviewed and updated as new scientific evidence becomes available. Working with WHO, CDC continuously monitors peer-reviewed literature and updates recommendations as needed, with comprehensive reviews approximately every 5 years. CDC is currently planning for the next update of the US MEC and US SPR and will consider public comments when determining the scope of the guidance update. CDC is seeking feedback from health care providers, professional organizations, community-based organizations, organizations that seek to improve reproductive health, patient advocacy groups, and the public.

                    The current US MEC may be found at the Supplementary Materials tab of the docket and at                     *https://www.cdc.gov/​reproductivehealth/​contraception/​mmwr/​mec/​summary.html.*                     The current US SPR may be found at the Supplementary Materials tab of the docket and at                     *https://www.cdc.gov/​reproductivehealth/​contraception/​mmwr/​spr/​summary.html.*

## References

1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2017-2019. NCHS Data Brief 2020:388;1-8.

2. Zapata LB, Pazol K, Curtis KM et al. Need for contraceptive services among women of reproductive age—45 jurisdictions, United States, 2017-2019. MMWR Morb Mortal Wkly Rep 2021;70:910-15.

3. Marcell AV, Gibbs SE, Choiriyyah I et al. National needs of family planning among US men aged 15 to 44 years. Am J Public Health 2016:106;733-9.

4. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep 2016;65(RR-3):1-103.

5. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep 2016;65(RR-4):1-66.

Dated: August 16, 2021.

Sandra Cashman,

Executive Secretary, Centers for Disease Control and Prevention.

[FR Doc. 2021-17818 Filed 8-18-21; 8:45 am]

BILLING CODE 4163-18-P