28652 Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices 

Vulnerabilities and Actionable 

Process Steps 

• Chapter Three—Mitigation Strategies 

for Actionable Process Steps 

• Chapter Four—Mitigation Strategies 

Management Components: Food 

Defense Monitoring 

• Appendix—Food Defense Plan 

Worksheets 

We intend to announce the 

availability for public comment of 

additional and expanded chapters of the 

draft guidance as we complete them. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on food defense 

measures against intentional 

adulteration for the regulation 

‘‘Mitigation Strategies to Protect Food 

Against Intentional Adulteration.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 507 have 

been approved under OMB control 

number 0910–0789. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Regulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: June 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13222 Filed 6–19–18; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital 

and Health Statistics (NCVHS), 

Standards Subcommittee Meeting. 

Date and Times: Tuesday, July 17, 

2018: 9:00 a.m.–5:00 p.m. (EDT), 

Wednesday, July 18, 2018: 8:30 a.m.– 

3:00 p.m. (EDT) 

Place: U.S. Department of Health and 

Human Services, Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Rm. 705A, Washington, DC 20201. 

Status: Open. There will be three 

opportunities for public comment 

during the meeting: At the end of the 

first day, at the end of the morning of 

the second day, and prior to the meeting 

close on the second day. 

Purpose: The NCVHS Charter 

stipulates that the Committee study the 

issues related to the adoption of uniform 

data standards for patient medical 

record information and the electronic 

exchange of such information and report 

to the Secretary of Health and Human 

Services (HHS) with recommendations 

and legislative proposals for such 

standards and electronic exchange. 

NCVHS also is charged with advising 

HHS on health data collection needs 

and strategies, and reviewing and 

monitoring the Department’s data and 

information systems to identify needs, 

opportunities, and problems. 

In this regard, NCVHS is taking a 

contemporary look at the health 

terminology and vocabulary landscape 

in order to advise the HHS Secretary 

regarding: (1) The changing 

environment and implications for 

timing and approach to health 

terminology and vocabulary standards 

adoption; (2) Needs, opportunities, and 

problems with development, 

dissemination, maintenance, and 

adoption of health terminology and 

vocabulary standards; and (3) Actions 

that HHS might take to improve 

development, dissemination, 

maintenance, and adoption of 

standards. 

NCVHS is holding an expert 

roundtable meeting, in conjunction with 

the National Library of Medicine (NLM) 

in order to: (1) Assess strengths, 

weaknesses and gaps in the U.S. health 

terminology and vocabulary (T/V) 

environment; (2) Consider areas for near 

term improvement in the development, 

maintenance, dissemination and 

adoption of named code sets; (3) Discuss 

opportunities for improved governance, 

coordination and communication across 

terminology and vocabulary developers 

and their stakeholders; (4) Identify top 

priority gaps in the U.S. health 

terminology and vocabulary coverage; 

and (5) Envision a roadmap for 

introducing improvements over the next 

decade. Invited experts will have the 

opportunity to provide extensive input 

to the subcommittee as it studies these 

questions and finalizes an 

Environmental Scan report of the 

current state of the U.S. health 

terminology and vocabulary (T/V) 

environment. 

The times and topics for this meeting 

are subject to change. Please refer to the 

posted agenda for any updates. 

Contact Persons for More Information: 

Substantive program information may 

be obtained from Rebecca Hines, MHS, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Hyattsville, Maryland 

20782, telephone (301) 458–4715. 

Information pertaining to meeting 

content may be obtained from Vivian 

Auld, National Institutes of Health, 

National Library of Medicine, 8600 

Rockville Pike, Bethesda, Maryland, 

20894–3833, telephone (301) 496–7974. 

Summaries of meetings and a roster of 

Committee members are available on the 

NCVHS website: www.ncvhs.hhs.gov, 

where further information including a 

meeting agenda and instructions to 

access the live audio broadcast of the 

meeting will be posted. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 

Opportunity on (770) 488–3210 as soon 

as possible. 

Dated: June 14, 2018. 

Laina Bush, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2018–13179 Filed 6–19–18; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 


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