67754 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–21567 Filed 9–29–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2023–0080] 

Guidelines for the Use of Doxycycline 

Post-Exposure Prophylaxis for 

Bacterial Sexually Transmitted 

Infection (STI) Prevention; Request for 

Comment and Informational 

Presentation 

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 

proposed guidelines for the use of 

doxycycline post-exposure prophylaxis 

(PEP) for prevention of bacterial 

sexually transmitted infections (STI). 

The proposed guidelines for bacterial 

STI prevention include post-exposure 

prophylaxis with doxycycline 

(doxycycline PEP) because it has 

demonstrated benefit in reducing 

chlamydia, gonorrhea, and syphilis 

infections and represents a new 

approach to addressing STI prevention 

in populations at increased risk for 

these infections. Doxycycline PEP, 

when offered, should be implemented 

in the context of a comprehensive 

sexual health approach including risk 

reduction counseling, STI screening and 

treatment, recommended vaccination, 

and linkage to HIV pre-exposure 

prophylaxis (PrEP), HIV care, or other 

services, as appropriate. The purpose of 

the proposed guidelines is to provide 

updated clinical guidance for healthcare 

providers to inform the use of 

doxycycline PEP for preventing 

bacterial STI infections. CDC has made 

available a pre-recorded informational 

presentation to provide information 

about the studies considered when 

developing the proposed guideline, 

explain the public comment process, 

and provide an overview of important 

monitoring for antibiotic use and 

antibiotic resistance that the agency will 

be considering to address potential 

risks. 

DATES: Written comments must be 

received on or before November 16, 

2023. An Informational Presentation has 

been pre-recorded and is available at 

https://npin.cdc.gov/. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0080 by either of the methods listed 

below. Do not submit comments by 

email. CDC does not accept comments 

by email. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: [Division of STD Prevention, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, 

Mailstop US12–2, Atlanta, GA 30329, 

Attn: Docket No. CDC–2023–0080]. 

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. 

The informational presentation can be 

accessed at https://npin.cdc.gov/. 

FOR FURTHER INFORMATION CONTACT: John 

R. Papp, Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, 

Mailstop U12–3, Atlanta, GA 30329; 

Telephone: 404–639–8000; Email: 

jwp6@cdc.gov. 

SUPPLEMENTARY INFORMATION: CDC’s 

proposed guidelines for the use of postexposure prophylaxis with doxycycline 

for bacterial STI prevention in the 

United States is available under the 

Supporting and Related Materials tab in 

the docket for this notice, Docket No. 

CDC–2023–0080, on http://

www.regulations.gov. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. In addition, CDC invites comments 

specifically on the following questions 

proposed in this Notice: 

• Based on the evidence presented in 

the full guidelines document (see the 

Supporting and Related Materials tab in 

the docket), does the evidence support 

the proposed guidelines for the use of 

post-exposure prophylaxis with 

doxycycline for bacterial STI 

prevention, including but not limited to 

risks and benefits? If not, please state 

the reason why and, if available, 

provide additional evidence for 

consideration. 

• Are CDC’s proposed guidelines for 

the use of post-exposure prophylaxis 

with doxycycline bacterial STI 

prevention clearly written? If not, what 

changes do you propose to make it 

clear? 

• If implemented as currently drafted, 

do you believe the proposed guidelines 

for the use of post-exposure prophylaxis 

with doxycycline for bacterial STI 

prevention would result in improved 

prevention of bacterial STIs in the 

United States? If not, please provide an 

explanation and supporting data or 

evidence. 

• How can these proposed guidelines 

most effectively reach and be received 

by populations who would benefit from 

this intervention? 

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 

private or proprietary information such 

as Social Security numbers, medical 

information, inappropriate language, or 

duplicate/near duplicate examples of a 

mass-mail campaign. 

Background 

Incidence of sexually transmitted 

infections (STIs) caused by Neisseria 

gonorrhoeae (causative agent of 

gonorrhea), Chlamydia trachomatis 

(causative agent of chlamydia), and 

Treponema pallidum (causative agent of 

syphilis) continues to increase in the 

United States. Novel approaches are 

needed to address the STI epidemic, 

especially for populations 

disproportionately affected (1). Postexposure prophylaxis (PEP) involves 

taking a medication to prevent an 

infection after a possible exposure and 

is a common strategy for prevention of 

HIV and other infections. PEP is a form 

of chemoprophylaxis and distinct from 

pre-exposure prophylaxis (PrEP) which 

involves taking a medication before 

exposure occurs. Doxycycline, a broadspectrum tetracycline antibiotic, is used 

as pre- or post-exposure prophylaxis to 

prevent infections such as malaria and 

Lyme disease (2). Doxycycline is well 


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Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 67755 

absorbed and tolerated, with a half-life 

of approximately 12 hours (3). Adverse 

effects most associated with 

doxycycline are photosensitivity and 

gastrointestinal symptoms including 

esophageal erosion and ulceration (4). 

Most adverse effects resolve when the 

medication is stopped. Doxycycline is 

the recommended treatment regimen for 

chlamydia and an alternative treatment 

for syphilis in non-pregnant patients 

with severe penicillin allergy or when 

penicillin is not available (5). 

The 2021 CDC STI Treatment 

Guidelines included a systematic review 

of the available literature on STI PEP 

and concluded that further studies were 

necessary to determine whether it 

would be an effective strategy for 

bacterial STI prevention (5). Since that 

time, promising results from several 

randomized trials on doxycycline PEP 

indicated the need to re-address this 

topic (6, 7). The new guidelines will 

offer an important resource for 

healthcare providers to inform the use 

of doxycycline PEP for preventing 

bacterial STI infections. CDC plans to 

use multiple surveillance systems to 

monitor impacts of the proposed 

guidelines including potential impacts 

on antibiotic use and antibiotic 

resistance in both STI and non-STI 

pathogens. 

All comments received will be 

carefully reviewed and considered. The 

proposed guidelines are also undergoing 

peer review. All comments will be 

addressed in the final guidelines and 

the proposed guidelines will be revised 

as appropriate. CDC will publish 

another notice announcing the 

availability of the final guidelines. 

References 

1. STI National Strategic Plan, 2021–2025 

[internet]. Available from: www.hhs.gov/ 

programs/topic-sites/sexuallytransmitted-infections/plan-overview/ 

index.html. 

2. Nadelman RB, Nowakowski J, Fish D, 

Falco RC, Freeman K, McKenna D, et al. 

Prophylaxis with single-dose 

doxycycline for the prevention of Lyme 

disease after an Ixodes scapularis tick 

bite. N Engl J Med. 2001 Jul 

12;345(2):79–84. 

3. Peyriere H, Makinson A, Marchandin H, 

Reynes J. Doxycycline in the 

management of sexually transmitted 

infections. J Antimicrob Chemother. 

2018 Mar 1;73(3):553–63. 

4. Sloan B, Scheinfeld N. The use and safety 

of doxycycline hyclate and other secondgeneration tetracyclines. Expert Opin 

Drug Saf. 2008 Sep;7(5):571–7. 

5. Workowski K, Bachmann L, Chan P, 

Johnston C, Muzny C, Park I, et al. 

Sexually Transmitted Infections 

Treatment Guidelines, 2021. MMWR. 

2021; 70:1–187. 

6. Luetkemeyer AF, Donnell D, Dombrowski 

JC, Cohen S, Grabow C, Brown CE, et al. 

Postexposure Doxycycline to Prevent 

Bacterial Sexually Transmitted 

Infections. N Engl J Med. 2023 Apr 

6;388(14):1296–306. 

7. Jean-Michel Molina, Beatrice Bercot, 

Lambert Assoumou, Algarte-Genin 

Michele, Emma Rubenstein, Gilles 

Pialoux, et al. ANRS 174 DOXYVAC: An 

Open-Label Randomized Trial to Prevent 

STIs in MSM on PrEP. CROI [internet]. 

2023 Feb 19; Seattle, Washington. 

Available from: https://

www.croiconference.org/abstract/anrs174-doxyvac-an-open-label-randomizedtrial-to-prevent-stis-in-msm-on-prep/. 

Dated: September 27, 2023. 

Kathryn L. Wolff, 

Chief of Staff, Centers for Disease Control 

and Prevention. 

[FR Doc. 2023–21725 Filed 9–29–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–26, CMS–R– 

185, CMS–116, CMS–2746 and CMS–10261] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice; partial withdrawal. 

SUMMARY: On Monday, September 25, 

2023, the Centers for Medicare & 

Medicaid Services (CMS) published a 

notice document entitled, ‘‘Agency 

Information Collection Activities: 

Submission for OMB Review; Comment 

Request.’’ That notice invited public 

comments on five separate information 

collection requests, under Document 

Identifiers: CMS–R–26, CMS–R– 185, 

CMS–116, CMS–2746 and CMS–10261. 

Through the publication of this 

document, we are withdrawing the 

portion of the notice requesting public 

comment on the information collection 

request titled, ‘‘Clinical Laboratory 

Improvement Amendments (CLIA) 

Regulations.’’ Form number: CMS–R–26 

(OMB control number: 0938–0612). We 

are also withdrawing the portion of the 

notice requesting public comment on 

the information collection request titled, 

‘‘Granting and Withdrawal of Deeming 

Authority to Private Nonprofit 

Accreditation Organizations and CLIA 

Exemption Under State Laboratory 

Programs.’’ Form number: CMS–R–185 

(OMB control number 0938–0686). 

DATES: The original comment period for 

the document that published on 

September 25, 2023, remains in effect 

and ends October 25, 2023. 

SUPPLEMENTARY INFORMATION: 

In FR document, 2023–20739, 

published on September 25, 2023 (88 FR 

65689), we are withdrawing item 1 ’’ 

Clinical Laboratory Improvement 

Amendments (CLIA) Regulations’’ 

which begins on page 65689. We are 

also withdrawing item 2 ’’ Granting and 

Withdrawal of Deeming Authority to 

Private Nonprofit Accreditation 

Organizations and CLIA Exemption 

Under State Laboratory Programs.’’ 

which begin on page 65690. These items 

were published in error. Both items will 

be republished at a later date, thereby 

providing the public a full 30-day 

comment period as required by the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: September 27, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–21669 Filed 9–29–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3443–FN] 

Medicare and Medicaid Programs; 

Application From the Center for 

Improvement in Healthcare Quality for 

Initial CMS Approval of Its Psychiatric 

Hospital 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces our 

decision to approve the Center for 

Improvement in Healthcare Quality 

(CIHQ) as a national accrediting 

organization (AO) for psychiatric 

hospitals that wish to participate in the 

Medicare or Medicaid programs. 

DATES: The decision announced in this 

notice is applicable on November 1, 

2023 through November 1, 2027. 

FOR FURTHER INFORMATION CONTACT: 

Donald Howard, (410) 786–6764 or 

Lillian Williams, (410) 786–8636. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a psychiatric hospital 


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