Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Notices 1041 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, 

Bethesda, MD 20892, 301–594–4805, 

adombroski@nidcr.nih.gov. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.nidcr.nih.gov/about, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: January 2, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00155 Filed 1–8–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

meeting of the National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; MSM Program 

Review (2018/05). 

Date: February 12, 2018. 

Time: 5:00 p.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy Plaza, 

Suite 920, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Manana Sukhareva, Ph.D., 

Scientific Review Officer, National Institutes 

of Biomedical Imaging and Bioengineering, 

National Institutes of Health, 6707 

Democracy Boulevard, Suite 959, Bethesda, 

MD 20892, (301) 451–3397, sukharem@

mail.nih.gov. 

Dated: January 2, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00154 Filed 1–8–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Confidentiality of Substance Use 

Disorder Patient Records 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) announces that it will hold 

a public listening session on 

Wednesday, January 31, 2018, to solicit 

information concerning the 

Confidentiality of Substance Use 

Disorder Patient Records regulations as 

required by Section 11002 of the 21st 

Century Cures Act. The listening session 

will provide an opportunity for the 

public to provide input to SAMHSA 

concerning the effect of part 2 on 

‘‘patient care, health outcomes, and 

patient privacy’’ as well as potential 

regulatory changes and future 

subregulatory guidance. 

DATES: The listening session will be 

held on Wednesday, January 31, 2018, 

from 8:30 a.m. (Eastern) to 1:00 p.m. 

(Eastern). 

FOR FURTHER INFORMATION CONTACT: For 

information concerning the listening 

session, please contact Rachel Karton, 

Senior Legislative and Regulatory 

Analyst, SAMHSA, 5600 Fishers Lane, 

Rockville, MD 20857, (240) 276–0416 or 

email PrivacyRegulations@

SAMHSA.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Participation: The Listening Session 

proceeding will be recorded, and 

subsequently archived and posted on 

the SAMHSA website. The public may 

attend the listening session: 

• Via Teleconference/Webcast: The 

entire proceeding will be streamed live 

over the internet (requires prior 

registration). Audio and streaming 

information will be sent to those who 

register prior to the meeting. Capacity 

for the Teleconference/Webcast 

participation is limited so early 

registration is recommended. 

• In Person: The address for this 

meeting is 5600 Fishers Lane, 5th 

(Main) Floor Pavilion rooms, Rockville, 

Maryland 20852. The building is a 

federal facility; prior registration, a 

security screening and a federallyapproved identification (e.g., driver’s 

license) are required to attend in-person. 

Capacity for in-person attendance is 

limited so early registration is 

recommended. 

Registration: Registration is required 

for participation in the listening session 

in person or via Teleconference/ 

Webcast. Registration is now open. 

Registration for the in-person session 

will close on 01/22/2018 at 12:00 p.m. 

Eastern Time (ET). Registration for the 

Teleconference/Webcast will close on 

01/31/2018 at 8:30 a.m. ET. Persons 

registering should indicate if they wish 

to make a public comment. SAMHSA 

recommends that when commenters 

suggest changes or revisions to current 

regulations that they indicate 

specifically, when feasible, how such 

regulation text should be revised. Only 

one representative of an organization 

may be allowed to present oral 

comments. Presentations will be limited 

to three minutes per speaker. SAMHSA 

will try to accommodate all speakers 

who wish to present based on the time 

allotted for this meeting. Persons 

making oral presentations are 

encouraged to also submit written 

comments as discussed below. 

To register, go to: https://42-cfr-part2- 

listening-session.eventbrite.com. 

Special Assistance: Individuals who 

plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify Rachel 

Karton (contact information provided 

below) at least 10 days prior to the 

meeting. 

Public Comments: In addition to 

attending the session in person or 

joining via Teleconference/Webcast, the 

Agency offers several ways to provide 

comments. SAMHSA recommends that 

when commenters suggest changes or 

revisions to current regulations that they 

indicate specifically, when feasible, 

how such regulation text should be 

revised. You may provide comments 

through the following means: 

• Electronically: PrivacyRegulations@

SAMHSA.hhs.gov (preferred). 

• Regular, Express or Overnight Mail, 

or Hand Delivery or Courier: Written 

comments must be sent to the following 

address ONLY: Substance Abuse and 

Mental Health Services Administration 

(SAMHSA), Department of Health and 


sradovich on DSK3GMQ082PROD with NOTICES
1042 Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Notices 

Human Services, Attn: Mitchell Berger, 

SAMHSA, 5600 Fishers Lane, Room 

18E89C, Rockville, Maryland 20852. 

Due to the anticipated high volume of 

comments, please note that receipt of 

comments will not be acknowledged. 

Comments must be received by 5:00 

p.m. ET on Wednesday February 28, 

2018. 

Background: Title 42, section 290dd– 

2, of the United States Code, pertaining 

to Confidentiality of Records, provides 

that ‘‘[r]ecords of the identity, diagnosis, 

prognosis, or treatment of any patient 

which are maintained in connection 

with the performance of any program or 

activity relating to substance abuse 

education, prevention, training, 

treatment, rehabilitation, or research, 

which is conducted, regulated, or 

directly or indirectly assisted by any 

department or agency of the United 

States shall [. . .] be confidential and be 

disclosed only for the purposes and 

under the circumstances expressly 

authorized’’ by the statute or as 

otherwise provided. The statute further 

provides that such records may not be 

‘‘used to initiate or substantiate any 

criminal charges against a patient or to 

conduct any investigation of a patient’’ 

without an appropriate court order. 

The implementing regulations, 42 

CFR part 2, were first promulgated as a 

final rule on July 1, 1975 (40 FR 27802), 

and substantively updated in 1987 (52 

FR 21796). On February 9, 2016, 

SAMHSA issued a notice of proposed 

rulemaking (NPRM) regarding 

substantive changes to part 2 (81 FR 

6987) and on January 18, 2017, 

SAMHSA finalized changes to these 

regulations (82 FR 6052). The January 

2017 final rule became effective on 

March 21, 2017 (see 82 FR 10863, Feb. 

16, 2017). This final rule was intended 

to ‘‘ensure that patients with substance 

use disorders have the ability to 

participate in and benefit from health 

system delivery improvements, 

including from new integrated health 

care models while providing 

appropriate privacy safeguards.’’ The 

final rule made substantive changes to 

regulatory provisions regarding 

Definitions (§ 2.11), Applicability 

(§ 2.12), Confidentiality restrictions and 

safeguards (§ 2.13), Security for records 

(§ 2.16), Disposition of records by 

discontinued programs (§ 2.19), Consent 

requirements (§ 2.31), Re-disclosure 

(§ 2.32), Medical emergencies (§ 2.51), 

Research (§ 2.52), and Audit and 

evaluation (§ 2.53). 

Concurrently with finalizing these 

changes, SAMHSA issued a 

supplemental notice of proposed 

rulemaking (SNPRM) on January 18, 

2017, proposing additional changes to 

facilitate disclosures by lawful holders 

to their contractors, subcontractors, and 

legal representative for the purposes of 

payment and health care operations and 

for carrying out an audit or evaluation 

and to permit disclosures by lawful 

holders to those conducting audits and 

evaluations on behalf of a governmental 

agency providing financial assistance to 

or regulatory oversight over the lawful 

holder. SAMHSA also sought comments 

on other topics, including an option for 

an abbreviated prohibition on redisclosure notice. In January 2018, 

SAMHSA published a final rule 

implementing these changes. 

In response to the 2016 NPRM and 

since publication of the January 2017 

final rule and the SNPRM, SAMHSA 

has already heard from numerous 

stakeholders on a range of issues 

pertaining to part 2. For instance, some 

commenters asserted that part 2 has 

become a barrier to integration of care 

and research. Many commenters also 

have suggested that part 2 does not 

adequately align with the Health 

Insurance Portability and 

Accountability Act (HIPAA). SAMHSA 

also has received many comments 

emphasizing the continuing importance 

of part 2 in protecting patients who seek 

substance use disorder treatment from 

discrimination in housing, employment, 

education, and other settings as well as 

from criminal investigation and 

penalties. Some commenters also have 

urged SAMHSA to update part 2 penalty 

provisions and prevent what they 

believe to be misuse of patient 

identifying information. 

On December 13, 2016, the 21st 

Century Cures Act was signed into law 

(Pub. L. 114–255). Section 11002 of this 

law requires that, within one year of the 

effective date of the final rule, ‘‘the 

Secretary [HHS] shall convene relevant 

stakeholders to determine the effect of 

such regulations on patient care, health 

outcomes, and patient privacy.’’ The 

listening session on January 31, 2018, 

will solicit input focused on how part 

2 impacts patient care, health outcomes 

and patient privacy as well as potential 

regulatory changes and future 

subregulatory guidance. It is important 

to note that any recommendations of 

further changes to part 2 received 

during this meeting could, even if 

legally permissible and feasible, only be 

implemented after notice-and-comment 

as required by the Administrative 

Procedures Act. 

* * * * * 

Dated: January 3, 2017. 

Charles LoDico, 

Chemist. 

[FR Doc. 2018–00150 Filed 1–8–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Mental Health Services: 

Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA), 

Center for Mental Health Services 

(CMHS) National Advisory Council 

(NAC) will meet on February 14, 2018, 

from 8:30 a.m. to 5:00 p.m. E.D.T. The 

CMHS NAC will convene in both open 

and closed sessions on February 14, 

2018. 

The closed portion of the meeting will 

include discussion and evaluation of 

grant applications reviewed by 

SAMHSA’s Initial Review Groups, and 

involve an examination of confidential 

financial and business information as 

well as personal information concerning 

the applicants. Therefore, the meeting 

will be closed to the public from 8:30 

a.m. to 10:00 a.m. as determined by the 

Assistant Secretary for Mental Health 

and Substance Use, SAMHSA in 

accordance with Title 5 U.S.C. 

552b(c)(4) and (6) and Title 5 U.S.C. 

App. 2, 10(d). 

The remainder of this meeting will be 

open to the public from 10:00 a.m. to 

5:00 p.m., E.D.T., to include discussion 

of the Center’s policy issues, 

presentations on SAMHSA’s Policy Lab, 

Disaster Responses and a conversation 

with the Assistant Secretary for Mental 

Health and Substance Use. 

Attendance by the public will be 

limited to available space. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the council. Written 

submissions should be forwarded to the 

contact person (below) on or before 

January 31, 2018. Oral presentations 

from the public will be scheduled at the 

conclusion of the meeting on 

Wednesday, February 14, 2018. Five 

minutes will be allotted for each 

presentation. Meeting information and a 

roster of Council members may be 

obtained either by accessing the 

SAMHSA Council website at http://

www.samhsa.gov/about-us/advisorycouncils/cmhs-national-advisoryVerDate Sep<11>2014 15:58 Jan 08, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1

sradovich on DSK3GMQ082PROD with NOTICES