Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices 28651 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1398] 

Mitigation Strategies To Protect Food 

Against Intentional Adulteration; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Mitigation Strategies to Protect Food 

Against Intentional Adulteration: 

Guidance for Industry.’’ This draft 

guidance document, when finalized, 

will help food facilities that 

manufacture, process, pack, or hold 

food, and that are required to register 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) comply with 

the requirements of our regulation 

entitled ‘‘Mitigation Strategies to Protect 

Food Against Intentional Adulteration.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 17, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–1398 for ‘‘Mitigation Strategies 

to Protect Food Against Intentional 

Adulteration: Guidance for Industry.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Ryan Newkirk, Center for Food Safety 

and Applied Nutrition (HFS–005), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

3712, ryan.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public health by 

helping to ensure the safety and security 

of the food supply. FSMA enables FDA 

to focus more on preventing food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

FSMA added to the FD&C Act several 

new sections that reference intentional 

adulteration. For example, section 418 

of the FD&C Act (21 U.S.C. 350g) 

addresses intentional adulteration in the 

context of facilities that manufacture, 

process, pack, or hold food, and that are 

required to register under section 415 

(21 U.S.C. 350d). Section 420 of the 

FD&C Act (21 U.S.C. 350i) addresses 

intentional adulteration in the context 

of high-risk foods and exempts farms 

except for farms that produce milk. 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Mitigation Strategies to Protect Food 

Against Intentional Adulteration: 

Guidance for Industry.’’ This multichapter draft guidance for industry is 

intended to help food facilities required 

to comply develop and implement some 

of the components of a food defense 

plan, and meet other requirements 

under 21 CFR part 121. We are 

announcing the availability of the 

following chapters: 

• Introduction 

• Chapter One—The Food Defense Plan 

• Chapter Two—Vulnerability 

Assessment to Identify Significant 


sradovich on DSK3GMQ082PROD with NOTICES
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] 

BILLING CODE 4164–01–P 

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. 


sradovich on DSK3GMQ082PROD with NOTICES