48828 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 

for clinical laboratory test results in 

investigational study data provided in 

regulatory submissions submitted to the 

Center for Drug Evaluation and Research 

and to the Center for Biologics 

Evaluation and Research. FDA has 

determined, in response to industry 

comments and internal review, that it is 

appropriate to extend the date required 

to submit LOINC codes in new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

biologics license applications (BLAs), 

and for certain investigational new 

drugs (INDs). LOINC codes will be 

required in NDAs, ANDAs, and BLAs 

for studies that start after March 15, 

2020 (March 15, 2021, for certain INDs). 

ADDRESSES: You may submit either 

electronic or written comments 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– 

2015–N–1349 for ‘‘Extension of the 

Timetable Requirement to Submit Study 

Data in Logical Observation Identifiers 

Names and Codes.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

cderdatastandards@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911, stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On May 

14, 2015, FDA announced in the 

Federal Register (80 FR 27690) its 

adoption of LOINC for lab test results. 

FDA supports LOINC-coded laboratory 

test results because: (1) LOINC is widely 

used among clinical laboratories; (2) 

LOINC-coded lab data make the 

information easier to understand and 

analyze; and (3) the currently supported 

exchange standard for laboratory test 

results in clinical trials, the Study Data 

Tabulation Model (available at http://

www.cdisc.org/sdtm), already supports 

the exchange of LOINC codes (available 

at https://loinc.org/). FDA’s decision to 

adopt LOINC for lab test results is part 

of a larger FDA effort to align the use of 

data standards for clinical research with 

ongoing nationwide health information 

technology initiatives. The FDA Data 

Standards Catalog was updated to 

indicate FDA support for LOINC and a 

requirement date of March 15, 2018, for 

NDAs, ANDAs, and BLAs, and March 

15, 2019, for certain INDs (see https:// 

www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm). FDA has determined, in 

response to industry comments and 

internal review, that it is appropriate to 

extend the date required to submit 

LOINC codes. LOINC codes will be 

required in NDAs, ANDAs, and BLAs 

for studies that start after March 15, 

2020 (March 15, 2021, for certain INDs). 

Although use of LOINC codes are not 

required at this time, FDA continues to 

support and encourages the use of 

LOINC codes for clinical laboratory test 

results used in investigational study 

data. 

Dated: October 16, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22768 Filed 10–19–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6133] 

Application of the ‘‘Solely Engaged’’ 

Exemptions in Parts 117 and 507; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 


srobinson on DSKBC5CHB2PROD with NOTICES
Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48829 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

draft guidance for industry entitled 

‘‘Application of the ‘‘Solely Engaged’’ 

Exemptions in Parts 117 and 507; Draft 

Guidance for Industry.’’ The draft 

guidance, when finalized, will help 

establishments and facilities subject to 

certain FDA regulations determine 

whether they are ‘‘solely engaged’’ in 

certain activities. Establishments and 

facilities ‘‘solely engaged’’ in certain 

activities are exempt from some or all 

requirements of the regulations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 18, 2018, to ensure that the 

Agency considers your comment on the 

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– 

2017–D–6133 for ‘‘Application of the 

‘‘Solely Engaged’’ Exemptions in Parts 

117 and 507: 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 office 

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 draft guidance to the Office 

of Food Safety (HFS–300), 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 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: For 

questions relating to the guidance as it 

applies to human food: Jenny Scott, 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2166. 

For questions relating to the guidance as 

it applies to animal food: Jeanette 

Murphy, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6246. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Application of the ‘‘Solely Engaged’’ 

Exemptions in Parts 117 and 507.’’ We 

are issuing the draft guidance consistent 

with our good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the current thinking of the FDA on this 

topic. It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternate 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

This guidance concerns two 

regulations that we have established in 

Title 21 of the Code of Federal 

Regulations as part of our 

implementation of the FDA Food Safety 

Modernization Act (FSMA; Pub. L. 111– 

353). These two regulations are part 117 

(published in the Federal Register on 

September 17, 2015, 80 FR 55908 and 

part 507 (published in the Federal 

Register on September 17, 2015, 80 FR 

56170). This guidance is intended to 

help establishments and facilities 

subject to part 117 or part 507 determine 

whether they are ‘‘solely engaged’’ in 

certain activities. Establishments and 

facilities ‘‘solely engaged’’ in certain 

activities are exempt from some or all 

requirements in parts 117 or 507. 

Parts 117 and 507 contain exemptions 

specific to establishments and facilities 

‘‘solely engaged’’ in certain activities. 

The relevant exemptions can be 

categorized as follows: (1) Exemption 

from human food current good 

manufacturing practice (CGMP) 

requirements, (2) exemption from 

human food preventive controls 


srobinson on DSKBC5CHB2PROD with NOTICES
48830 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 

requirements, (3) exemption from 

animal food CGMP requirements, and 

(4) exemption from animal food 

preventive controls requirements. 

This draft guidance, when finalized, 

will clarify that if all of the activities 

performed by an establishment are 

exempt under one or more CGMP 

exemptions, then the establishment is 

not subject to the part 117 and/or part 

507 CGMPs, as applicable. If all the 

activities performed by a facility are 

exempt under one or more preventive 

controls exemptions, then the facility is 

not subject to the part 117 and/or part 

507 preventive controls requirements, as 

applicable. If all the activities performed 

by a facility are exempt under one or 

more CGMP exemptions and one or 

more preventive controls exemptions, 

then the facility is not subject to the 

CGMP or preventive controls 

requirements in part 117 and/or part 

507, as applicable. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances or 

https://www.fda.gov/ForIndustry/ 

ColorAdditives/

GuidanceComplianceRegulatory

Information/ucm153033.htm 

(whichever is applicable) or https://

www.regulations.gov. Use the FDA Web 

site listed in the previous sentence to 

find the most current version of the 

guidance. 

Dated: October 16, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22731 Filed 10–19–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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. 

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: Center for Scientific 

Review Special Emphasis Panel; Program 

Project: Cell Biology. 

Date: November 9, 2017. 

Time: 11:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: David Balasundaram, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5189, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1022, balasundaramd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Radiation Therapy and Biology. 

Date: November 14–15, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Bo Hong, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health. 6701 Rockledge 

Drive, Room 6194, MSC 7804, Bethesda, MD 

20892, 301–996–6208, hongb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; National 

Swine Resource and Research center review. 

Date: November 14, 2017. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Katherine M. Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, 301–435– 

0912, Katherine_Malinda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Disease 

Prevention and Management, Risk Reduction 

and Health Behavior Change. 

Date: November 16–17, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco, 2 North Charles 

Street, Baltimore, MD 21201. 

Contact Person: Michael John McQuestion, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

Bethesda, MD 20892, 301–480–1276, 

mike.mcquestion@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Aging and Development, Auditory, 

Vision and Low Vision Technologies. 

Date: November 16–17, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Darcy Washington DC, 1515 

Rhode Island Ave. NW., Washington, DC 

20005. 

Contact Person: Paek-Gyu Lee, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4201, 

MSC 7812, Bethesda, MD 20892, (301) 613– 

2064, leepg@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Cancer Biotherapeutics 

Development. 

Date: November 16–17, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn San Antonio Riverwalk, 

217 N St. Mary’s, San Antonio, TX 78205. 

Contact Person: Nicholas J. Donato, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040, 

Bethesda, MD 20817, 301–827–4810, 

nick.donato@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Cancer Drug Development and 

Therapeutics. 

Date: November 16–17, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn San Antonio Riverwalk, 

217 North St. Mary’s, San Antonio, TX 

78205. 

Contact Person: Lilia Topol, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6192, 

MSC 7804, Bethesda, MD 20892, 301–451– 

0131, ltopol@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Medical Imaging. 

Date: November 16–17, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Mark Center, 

5000 Seminary Road, Alexandria, VA 22311. 

Contact Person: Leonid V. Tsap, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5128, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

2507, tsapl@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; AIDS 

Discovery and Development of Therapeutics 

Study Section. 

Date: November 16, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Mayflower Park Hotel, 405 Olive 

Way, Seattle, WA 98101. 

Contact Person: Shiv A. Prasad, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892, 301–443– 

5779, prasads@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 


srobinson on DSKBC5CHB2PROD with NOTICES