82_FR_49030 82 FR 48828 - Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability

82 FR 48828 - Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 202 (October 20, 2017)

Page Range48828-48830
FR Document2017-22731

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 507; Draft Guidance for Industry.'' The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are ``solely engaged'' in certain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.

Federal Register, Volume 82 Issue 202 (Friday, October 20, 2017) 
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48828-48830]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22731]


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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507; Draft Guidance for Industry; Availability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.

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[[Page 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announcing the availability of a draft guidance for industry entitled 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507; Draft Guidance for Industry.'' The draft guidance, when finalized, 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DATES: Submit either electronic or written comments on the draft 
guidance by April 18, 2018, to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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.thefederalregister.org/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

[[Page 48830]]

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/GuidanceComplianceRegulatoryInformation/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

48828 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices for clinical laboratory test results in Instructions: All submissions received Evaluation and Research, Food and investigational study data provided in must include the Docket No. FDA– Drug Administration, 10903 New regulatory submissions submitted to the 2015–N–1349 for ‘‘Extension of the Hampshire Ave., Bldg. 71, Rm. 7268, Center for Drug Evaluation and Research Timetable Requirement to Submit Study Silver Spring, MD 20993–0002, 240– and to the Center for Biologics Data in Logical Observation Identifiers 402–7911, stephen.ripley@fda.hhs.gov. Evaluation and Research. FDA has Names and Codes.’’ Received comments SUPPLEMENTARY INFORMATION: On May determined, in response to industry will be placed in the docket and, except 14, 2015, FDA announced in the comments and internal review, that it is for those submitted as ‘‘Confidential Federal Register (80 FR 27690) its appropriate to extend the date required Submissions,’’ publicly viewable at adoption of LOINC for lab test results. to submit LOINC codes in new drug https://www.regulations.gov or at the FDA supports LOINC-coded laboratory applications (NDAs), abbreviated new Dockets Management Staff between test results because: (1) LOINC is widely drug applications (ANDAs), and 9 a.m. and 4 p.m., Monday through used among clinical laboratories; (2) biologics license applications (BLAs), Friday. LOINC-coded lab data make the and for certain investigational new • Confidential Submissions—To information easier to understand and drugs (INDs). LOINC codes will be submit a comment with confidential analyze; and (3) the currently supported required in NDAs, ANDAs, and BLAs information that you do not wish to be exchange standard for laboratory test for studies that start after March 15, made publicly available, submit your results in clinical trials, the Study Data 2020 (March 15, 2021, for certain INDs). comments only as a written/paper Tabulation Model (available at http:// ADDRESSES: You may submit either submission. You should submit two www.cdisc.org/sdtm), already supports electronic or written comments at any copies total. One copy will include the the exchange of LOINC codes (available time as follows: information you claim to be confidential at https://loinc.org/). FDA’s decision to Electronic Submissions with a heading or cover note that states adopt LOINC for lab test results is part ‘‘THIS DOCUMENT CONTAINS of a larger FDA effort to align the use of Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The data standards for clinical research with following way: Agency will review this copy, including • Federal eRulemaking Portal: ongoing nationwide health information the claimed confidential information, in technology initiatives. The FDA Data https://www.regulations.gov. Follow the its consideration of comments. The instructions for submitting comments. Standards Catalog was updated to second copy, which will have the indicate FDA support for LOINC and a Comments submitted electronically, claimed confidential information including attachments, to https:// requirement date of March 15, 2018, for redacted/blacked out, will be available NDAs, ANDAs, and BLAs, and March www.regulations.gov will be posted to for public viewing and posted on the docket unchanged. Because your 15, 2019, for certain INDs (see https:// https://www.regulations.gov. Submit www.fda.gov/forindustry/ comment will be made public, you are both copies to the Dockets Management solely responsible for ensuring that your datastandards/studydatastandards/ Staff. If you do not wish your name and default.htm). FDA has determined, in comment does not include any contact information to be made publicly confidential information that you or a response to industry comments and available, you can provide this internal review, that it is appropriate to third party may not wish to be posted, information on the cover sheet and not such as medical information, your or extend the date required to submit in the body of your comments and you LOINC codes. LOINC codes will be anyone else’s Social Security number, or must identify this information as confidential business information, such required in NDAs, ANDAs, and BLAs ‘‘confidential.’’ Any information marked for studies that start after March 15, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed that if you include your name, contact 2020 (March 15, 2021, for certain INDs). except in accordance with 21 CFR 10.20 Although use of LOINC codes are not information, or other information that and other applicable disclosure law. For identifies you in the body of your required at this time, FDA continues to more information about FDA’s posting support and encourages the use of comments, that information will be of comments to public dockets, see 80 posted on https://www.regulations.gov. LOINC codes for clinical laboratory test FR 56469, September 18, 2015, or access results used in investigational study • If you want to submit a comment the information at: https://www.gpo.gov/ with confidential information that you data. fdsys/pkg/FR-2015-09-18/pdf/2015- do not wish to be made available to the 23389.pdf. Dated: October 16, 2017. public, submit the comment as a Docket: For access to the docket to Leslie Kux, written/paper submission and in the read background documents or the Associate Commissioner for Policy. manner detailed (see ‘‘Written/Paper electronic and written/paper comments [FR Doc. 2017–22768 Filed 10–19–17; 8:45 am] Submissions’’ and ‘‘Instructions’’). received, go to https:// BILLING CODE 4164–01–P Written/Paper Submissions www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the heading of this document, into the DEPARTMENT OF HEALTH AND follows: HUMAN SERVICES • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets and/or go to the Dockets Management Food and Drug Administration Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Drug Administration, 5630 Fishers Rockville, MD 20852. [Docket No. FDA–2017–D–6133] FOR FURTHER INFORMATION CONTACT: Ron srobinson on DSKBC5CHB2PROD with NOTICES Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Fitzmartin, Center for Drug Evaluation Application of the ‘‘Solely Engaged’’ submitted to the Dockets Management and Research, Food and Drug Exemptions in Parts 117 and 507; Draft Staff, FDA will post your comment, as Administration, 10903 New Hampshire Guidance for Industry; Availability well as any attachments, except for Ave., Bldg. 51, Rm. 1115, Silver Spring, AGENCY: Food and Drug Administration, information submitted, marked and MD 20993–0002, 301–796–5333, HHS. identified, as confidential, if submitted cderdatastandards@fda.hhs.gov; or ACTION: Notification of availability. as detailed in ‘‘Instructions.’’ Stephen Ripley, Center for Biologics VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48829 SUMMARY: The Food and Drug information submitted, marked and Food Safety and Applied Nutrition, Administration (FDA, the Agency, or identified, as confidential, if submitted Food and Drug Administration, 5001 we) is announcing the availability of a as detailed in ‘‘Instructions.’’ Campus Dr., College Park, MD 20740. draft guidance for industry entitled Instructions: All submissions received Send two self-addressed adhesive labels ‘‘Application of the ‘‘Solely Engaged’’ must include the Docket No. FDA– to assist that office in processing your Exemptions in Parts 117 and 507; Draft 2017–D–6133 for ‘‘Application of the request. See the SUPPLEMENTARY Guidance for Industry.’’ The draft ‘‘Solely Engaged’’ Exemptions in Parts INFORMATION section for electronic guidance, when finalized, will help 117 and 507: Guidance for Industry.’’ access to the draft guidance. establishments and facilities subject to Received comments will be placed in FOR FURTHER INFORMATION CONTACT: For certain FDA regulations determine the docket and, except for those questions relating to the guidance as it whether they are ‘‘solely engaged’’ in submitted as ‘‘Confidential applies to human food: Jenny Scott, certain activities. Establishments and Submissions,’’ publicly viewable at Center for Food Safety and Applied facilities ‘‘solely engaged’’ in certain https://www.regulations.gov or at the Nutrition, Food and Drug activities are exempt from some or all Dockets Management Staff office Administration, 5001 Campus Dr., requirements of the regulations. between 9 a.m. and 4 p.m., Monday College Park, MD 20740, 240–402–2166. DATES: Submit either electronic or through Friday. For questions relating to the guidance as • Confidential Submissions—To written comments on the draft guidance it applies to animal food: Jeanette submit a comment with confidential by April 18, 2018, to ensure that the Murphy, Center for Veterinary information that you do not wish to be Agency considers your comment on the Medicine, Food and Drug made publicly available, submit your draft guidance before it begins work on Administration, 7519 Standish Pl., comments only as a written/paper the final version of the guidance. Rockville, MD 20855, 240–402–6246. submission. You should submit two ADDRESSES: You may submit comments copies total. One copy will include the SUPPLEMENTARY INFORMATION: on any guidance at any time as follows: information you claim to be confidential I. Background Electronic Submissions with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS We are announcing the availability of Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The a draft guidance for industry entitled following way: Agency will review this copy, including ‘‘Application of the ‘‘Solely Engaged’’ • Federal eRulemaking Portal: the claimed confidential information, in Exemptions in Parts 117 and 507.’’ We https://www.regulations.gov. Follow the its consideration of comments. The are issuing the draft guidance consistent instructions for submitting comments. second copy, which will have the with our good guidance practices Comments submitted electronically, claimed confidential information regulation (21 CFR 10.115). The draft including attachments, to https:// redacted/blacked out, will be available guidance, when finalized, will represent www.regulations.gov will be posted to for public viewing and posted on the current thinking of the FDA on this the docket unchanged. Because your https://www.regulations.gov. Submit topic. It does not establish any rights for comment will be made public, you are both copies to the Dockets Management any person and is not binding on FDA solely responsible for ensuring that your Staff. If you do not wish your name and or the public. You can use an alternate comment does not include any contact information to be made publicly approach if it satisfies the requirements confidential information that you or a available, you can provide this of the applicable statutes and third party may not wish to be posted, information on the cover sheet and not regulations. This guidance is not subject such as medical information, your or in the body of your comments and you to Executive Order 12866. anyone else’s Social Security number, or must identify this information as This guidance concerns two confidential business information, such ‘‘confidential.’’ Any information marked regulations that we have established in as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Title 21 of the Code of Federal that if you include your name, contact except in accordance with 21 CFR 10.20 Regulations as part of our information, or other information that and other applicable disclosure law. For implementation of the FDA Food Safety identifies you in the body of your more information about FDA’s posting Modernization Act (FSMA; Pub. L. 111– comments, that information will be of comments to public dockets, see 80 353). These two regulations are part 117 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access (published in the Federal Register on • If you want to submit a comment the information at: https://www.gpo.gov/ September 17, 2015, 80 FR 55908 and with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- part 507 (published in the Federal do not wish to be made available to the 23389.pdf. Register on September 17, 2015, 80 FR public, submit the comment as a Docket: For access to the docket to 56170). This guidance is intended to written/paper submission and in the read background documents or the help establishments and facilities manner detailed (see ‘‘Written/Paper electronic and written/paper comments subject to part 117 or part 507 determine Submissions’’ and ‘‘Instructions’’). received, go to https:// whether they are ‘‘solely engaged’’ in www.regulations.gov and insert the certain activities. Establishments and Written/Paper Submissions facilities ‘‘solely engaged’’ in certain docket number, found in brackets in the Submit written/paper submissions as heading of this document, into the activities are exempt from some or all follows: ‘‘Search’’ box and follow the prompts requirements in parts 117 or 507. • Mail/Hand delivery/Courier (for and/or go to the Dockets Management Parts 117 and 507 contain exemptions written/paper submissions): Dockets specific to establishments and facilities srobinson on DSKBC5CHB2PROD with NOTICES Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and Rockville, MD 20852. ‘‘solely engaged’’ in certain activities. Drug Administration, 5630 Fishers You may submit comments on any The relevant exemptions can be Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR categorized as follows: (1) Exemption • For written/paper comments 10.115(g)(5)). from human food current good submitted to the Dockets Management Submit written requests for single manufacturing practice (CGMP) Staff, FDA will post your comment, as copies of the draft guidance to the Office requirements, (2) exemption from well as any attachments, except for of Food Safety (HFS–300), Center for human food preventive controls VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

48830 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices requirements, (3) exemption from would constitute a clearly unwarranted Place: The Darcy Washington DC, 1515 animal food CGMP requirements, and invasion of personal privacy. Rhode Island Ave. NW., Washington, DC (4) exemption from animal food 20005. Name of Committee: Center for Scientific Contact Person: Paek-Gyu Lee, Ph.D., preventive controls requirements. Review Special Emphasis Panel; Program Scientific Review Officer, Center for This draft guidance, when finalized, Project: Cell Biology. Scientific Review, National Institutes of will clarify that if all of the activities Date: November 9, 2017. Health, 6701 Rockledge Drive, Room 4201, performed by an establishment are Time: 11:30 a.m. to 7:00 p.m. MSC 7812, Bethesda, MD 20892, (301) 613– exempt under one or more CGMP Agenda: To review and evaluate grant 2064, leepg@csr.nih.gov. exemptions, then the establishment is applications. Name of Committee: Center for Scientific not subject to the part 117 and/or part Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Small 507 CGMPs, as applicable. If all the Rockledge Drive, Bethesda, MD 20892 Business: Cancer Biotherapeutics activities performed by a facility are (Virtual Meeting). Development. exempt under one or more preventive Contact Person: David Balasundaram, Date: November 16–17, 2017. Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. controls exemptions, then the facility is Scientific Review, National Institutes of Agenda: To review and evaluate grant not subject to the part 117 and/or part Health, 6701 Rockledge Drive, Room 5189, applications. 507 preventive controls requirements, as MSC 7840, Bethesda, MD 20892, 301–435– Place: Holiday Inn San Antonio Riverwalk, applicable. If all the activities performed 1022, balasundaramd@csr.nih.gov. 217 N St. Mary’s, San Antonio, TX 78205. by a facility are exempt under one or Name of Committee: Center for Scientific Contact Person: Nicholas J. Donato, Ph.D., more CGMP exemptions and one or Review Special Emphasis Panel; Small Scientific Review Officer, Center for more preventive controls exemptions, Business: Radiation Therapy and Biology. Scientific Review, National Institutes of then the facility is not subject to the Date: November 14–15, 2017. Health, 6701 Rockledge Drive, Room 4040, CGMP or preventive controls Time: 8:00 a.m. to 6:00 p.m. Bethesda, MD 20817, 301–827–4810, nick.donato@nih.gov. requirements in part 117 and/or part Agenda: To review and evaluate grant 507, as applicable. applications. Name of Committee: Center for Scientific Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Small II. Electronic Access Rockledge Drive, Bethesda, MD 20892 Business: Cancer Drug Development and (Virtual Meeting). Therapeutics. Persons with access to the internet Date: November 16–17, 2017. may obtain the draft guidance at either Contact Person: Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, Time: 8:00 a.m. to 5:00 p.m. https://www.fda.gov/FoodGuidances or Agenda: To review and evaluate grant National Institutes of Health. 6701 Rockledge https://www.fda.gov/ForIndustry/ applications. Drive, Room 6194, MSC 7804, Bethesda, MD ColorAdditives/ 20892, 301–996–6208, hongb@csr.nih.gov. Place: Holiday Inn San Antonio Riverwalk, GuidanceComplianceRegulatory 217 North St. Mary’s, San Antonio, TX Name of Committee: Center for Scientific 78205. Information/ucm153033.htm Review Special Emphasis Panel; National (whichever is applicable) or https:// Contact Person: Lilia Topol, Ph.D., Swine Resource and Research center review. Scientific Review Officer, Center for www.regulations.gov. Use the FDA Web Date: November 14, 2017. Scientific Review, National Institutes of site listed in the previous sentence to Time: 1:00 p.m. to 3:00 p.m. Health, 6701 Rockledge Drive, Room 6192, find the most current version of the Agenda: To review and evaluate grant MSC 7804, Bethesda, MD 20892, 301–451– guidance. applications. 0131, ltopol@mail.nih.gov. Dated: October 16, 2017. Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel; Small Anna K. Abram, (Telephone Conference Call). Business: Medical Imaging. Deputy Commissioner for Policy, Planning, Contact Person: Katherine M. Malinda, Date: November 16–17, 2017. Legislation, and Analysis. Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. [FR Doc. 2017–22731 Filed 10–19–17; 8:45 am] Scientific Review, National Institutes of Agenda: To review and evaluate grant BILLING CODE 4164–01–P Health, 6701 Rockledge Drive, Room 4140, applications. MSC 7814, Bethesda, MD 20892, 301–435– Place: Hilton Alexandria Mark Center, 0912, Katherine_Malinda@csr.nih.gov. 5000 Seminary Road, Alexandria, VA 22311. DEPARTMENT OF HEALTH AND Name of Committee: Center for Scientific Contact Person: Leonid V. Tsap, Ph.D., HUMAN SERVICES Review Special Emphasis Panel; Disease Scientific Review Officer, Center for Prevention and Management, Risk Reduction Scientific Review, National Institutes of National Institutes of Health and Health Behavior Change. Health, 6701 Rockledge Drive, Room 5128, Date: November 16–17, 2017. MSC 7854, Bethesda, MD 20892, (301) 435– Center for Scientific Review; Notice of Time: 8:00 a.m. to 5:00 p.m. 2507, tsapl@csr.nih.gov. Closed Meetings Agenda: To review and evaluate grant Name of Committee: AIDS and Related applications. Research Integrated Review Group; AIDS Pursuant to section 10(d) of the Place: Hotel Monaco, 2 North Charles Discovery and Development of Therapeutics Federal Advisory Committee Act, as Street, Baltimore, MD 21201. Study Section. amended, notice is hereby given of the Contact Person: Michael John McQuestion, Date: November 16, 2017. following meetings. Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. The meetings will be closed to the Scientific Review, National Institutes of Agenda: To review and evaluate grant public in accordance with the Health, 6701 Rockledge Drive, Room 3114, applications. provisions set forth in sections Bethesda, MD 20892, 301–480–1276, Place: Mayflower Park Hotel, 405 Olive mike.mcquestion@nih.gov. Way, Seattle, WA 98101. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., srobinson on DSKBC5CHB2PROD with NOTICES Name of Committee: Center for Scientific Contact Person: Shiv A. Prasad, Ph.D., as amended. The grant applications and Scientific Review Officer, Center for Review Special Emphasis Panel; Small the discussions could disclose Business: Aging and Development, Auditory, Scientific Review, National Institutes of confidential trade secrets or commercial Vision and Low Vision Technologies. Health, 6701 Rockledge Drive, Room 5220, property such as patentable material, Date: November 16–17, 2017. MSC 7852, Bethesda, MD 20892, 301–443– and personal information concerning Time: 8:00 a.m. to 5:00 p.m. 5779, prasads@csr.nih.gov. individuals associated with the grant Agenda: To review and evaluate grant Name of Committee: Center for Scientific applications, the disclosure of which applications. Review Special Emphasis Panel; Small VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1


Document Created: 2017-10-20 00:06:15
Document Modified: 2017-10-20 00:06:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotification of availability.
DatesSubmit 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.
ContactFor 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.
FR Citation82 FR 48828 
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