82 FR 4349 - Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4349-4351 | |
| FR Document | 2017-00646 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4349-4351] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00646] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0086] Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is establishing a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on policy issues that may be considered by the FDA Combination Product Policy Council (Council). These comments will help the Agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or other means. DATES: Submit either electronic or written comments by April 13, 2017. ADDRESSES: You may submit comments 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 [[Page 4350]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-N-0086 for ``Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council.'' 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 Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Nina L. Hunter, Office of Medical Products and Tobacco (OMPT), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2312, Silver Spring, MD 20993-0002, 301- 796-6171, FAX: 301-847-8514, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In April 2016, FDA established the Council to ensure better coordination of combination product policy development and implementation across the Agency and consistent, predictable communication of combination product policy decisions to the public through guidance, notice and comment procedures, or other means. Chaired by the Deputy Commissioner of OMPT, the Council provides a senior-level forum through which combination product policy issues can be raised, considered, developed, and implemented. Council members include the following senior leaders: The Center Directors and one representative from the Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and Radiological Health; the Office Director from the Office of Combination Products (OCP); and the Associate Commissioner for Special Medical Programs. Additional staff from the Centers and other FDA offices provide expertise as needed for specific combination product policy topics under consideration. While there are various other mechanisms available to raise issues for Agency consideration, by establishing this docket, FDA seeks to provide a forum for the public to recommend specific topics that should have direct, collective engagement and consideration by the Council. The Agency believes that this process will also further enhance transparency in FDA's approach to policy development and implementation. II. Range of Policy Issues To Be Considered FDA envisions a variety of combination product policy topics that may be appropriate for consideration by the Council, which typically would meet one or more of the following criteria: A novel combination product policy issue requiring senior management input; An identical issue on which FDA seems to have taken inconsistent combination product policy positions; An existing combination product policy position that should be reconsidered in light of scientific or regulatory advances; or A combination product policy that may be triggered by a specific combination product, but that will be applicable to other combination products. III. Establishment of a Docket and Request for Comments The docket is being made available for public suggestions, recommendations, and comments relating to the combination product policy criteria identified in this document that may warrant consideration by the Council. Submissions should describe the following: (1) The combination product policy issue recommended for discussion (e.g., clarifying previous advice or precedents on a specified combination product policy topic, reconciling apparently differing perspectives within FDA or between FDA and regulated industry on a specified combination product policy topic); (2) the rationale for doing so, including why it requires direct engagement by the Council; (3) recommendations on how the combination product policy issue could be addressed; and (4) existing policy documents (e.g., final guidance) relevant to the combination product policy issue. Note that combination product policy issues concerning any draft guidance or proposed rule should be submitted to the docket for that draft guidance or rulemaking; product-specific disputes should first be addressed through the appropriate appeals mechanism of the Center or other Agency component involved; and general recommendations for topics to address through guidance or rulemaking should be made to the Center, OCP, or other relevant Agency component through the mechanisms provided by that component. The Agency will carefully consider all comments submitted. FDA generally will not respond directly to the person or organization submitting the [[Page 4351]] comment. In general, combination product policy decisions reached by the Council are communicated and implemented in accordance with FDA's good guidance practices regulation (21 CFR 10.115) or notice and comment procedures. Dated: January 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00646 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
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http://www.regulations.gov or at the information, and comments to help us DEPARTMENT OF HEALTH AND
Division of Dockets Management determine whether a particular isolated HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday or synthetic non-digestible carbohydrate
through Friday. should be added to our definition of Food and Drug Administration
• Confidential Submissions—To ‘‘dietary fiber’’ that is found in the
submit a comment with confidential [Docket No. FDA–2017–N–0086]
Nutrition and Supplement Facts label
information that you do not wish to be final rule, which appeared in the Suggestions, Recommendations, and
made publicly available, submit your Federal Register of May 27, 2016 (81 FR Comments for Topics That May Be
comments only as a written/paper 33741). Only those isolated or synthetic Considered by the Food and Drug
submission. You should submit two non-digestible carbohydrates that meet Administration Combination Product
copies total. One copy will include the Policy Council; Establishment of a
the definition can be declared as a
information you claim to be confidential Docket
dietary fiber on a Nutrition and
with a heading or cover note that states
Supplement Facts label. The notice also
‘‘THIS DOCUMENT CONTAINS AGENCY: Food and Drug Administration,
CONFIDENTIAL INFORMATION.’’ We announced the availability of a HHS.
will review this copy, including the document entitled ‘‘Science Review of
Isolated and Synthetic Non-Digestible ACTION: Notice; establishment of docket;
claimed confidential information, in our request for comments.
consideration of comments. The second Carbohydrates,’’ which summarizes a
copy, which will have the claimed scientific literature review that we SUMMARY: The Food and Drug
confidential information redacted/ conducted of clinical studies associated Administration (FDA) is establishing a
blacked out, will be available for public with the 26 specific isolated or synthetic docket to receive suggestions,
viewing and posted on http:// non-digestible carbohydrates. We recommendations, and comments for
www.regulations.gov. Submit both provided a 45-day comment period that topics from interested parties, including
copies to the Division of Dockets ended on January 9, 2017. academic institutions, regulated
Management. If you do not wish your We have received requests to extend industry, patient representatives, and
name and contact information to be the period during which interested other interested organizations, on policy
made publicly available, you can parties may submit scientific data, issues that may be considered by the
provide this information on the cover information, and comments regarding FDA Combination Product Policy
sheet and not in the body of your Council (Council). These comments will
isolated or synthetic non-digestible
comments and you must identify this help the Agency identify and address
carbohydrates generally and regarding
information as ‘‘confidential.’’ Any combination product policy issues that
our scientific literature review summary need clarification through guidance,
information marked as ‘‘confidential’’
document specifically. The requests notice and comment procedures, or
will not be disclosed except in
accordance with 21 CFR 10.20 and other conveyed concern that the original 45- other means.
applicable disclosure law. For more day comment period would not allow
DATES: Submit either electronic or
information about FDA’s posting of sufficient time to develop meaningful or
written comments by April 13, 2017.
comments to public dockets, see 80 FR thoughtful scientific data, information,
ADDRESSES: You may submit comments
56469, September 18, 2015, or access or comments.
as follows:
the information at: http://www.fda.gov/ We have considered the requests but
regulatoryinformation/dockets/ were unable to issue a notice extending Electronic Submissions
default.htm. the comment period before January 9, Submit electronic comments in the
Docket: For access to the docket to 2017. Consequently, we are reopening following way:
read background documents or the the comment period for an additional 30 • Federal eRulemaking Portal:
electronic and written/paper comments days. Interested parties have until https://www.regulations.gov. Follow the
received, go to http:// February 13, 2017, to submit scientific instructions for submitting comments.
www.regulations.gov and insert the data, information, or comments to the Comments submitted electronically,
docket number, found in brackets in the docket. We believe that this action including attachments, to https://
heading of this document, into the www.regulations.gov will be posted to
allows adequate time for interested
‘‘Search’’ box and follow the prompts the docket unchanged. Because your
persons to submit additional scientific
and/or go to the Division of Dockets comment will be made public, you are
Management, 5630 Fishers Lane, Rm. data, information and comments.
solely responsible for ensuring that your
1061, Rockville, MD 20852. Dated: January 10, 2017. comment does not include any
FOR FURTHER INFORMATION CONTACT: Leslie Kux, confidential information that you or a
Paula R. Trumbo, Center for Food Safety Associate Commissioner for Policy. third party may not wish to be posted,
and Applied Nutrition (HFS–830), Food [FR Doc. 2017–00725 Filed 1–12–17; 8:45 am] such as medical information, your or
and Drug Administration, 5001 Campus BILLING CODE 4164–01–P anyone else’s Social Security number, or
Dr., College Park, MD 20740, 240–402– confidential business information, such
2579. as a manufacturing process. Please note
SUPPLEMENTARY INFORMATION: In the that if you include your name, contact
Federal Register of November 23, 2016 information, or other information that
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(81 FR 84595), we published a identifies you in the body of your
document requesting scientific data, comments, that information will be
information, and comments that would posted on https://www.regulations.gov.
help us evaluate the beneficial • If you want to submit a comment
physiological effects to human health of with confidential information that you
isolated or synthetic non-digestible do not wish to be made available to the
carbohydrate that are added to food. We public, submit the comment as a
requested such scientific data, written/paper submission and in the
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![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4351
comment. In general, combination Submit either written or electronic made publicly available, submit your
product policy decisions reached by the comments on this collection of comments only as a written/paper
Council are communicated and information by March 14, 2017. submission. You should submit two
implemented in accordance with FDA’s ADDRESSES: You may submit comments copies total. One copy will include the
good guidance practices regulation (21 as follows: information you claim to be confidential
CFR 10.115) or notice and comment with a heading or cover note that states
procedures. Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Dated: January 9, 2017.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
Leslie Kux, • Federal eRulemaking Portal: http:// the claimed confidential information, in
Associate Commissioner for Policy. www.regulations.gov. Follow the its consideration of comments. The
[FR Doc. 2017–00646 Filed 1–12–17; 8:45 am] instructions for submitting comments. second copy, which will have the
BILLING CODE 4164–01–P Comments submitted electronically, claimed confidential information
including attachments, to http:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on http://
DEPARTMENT OF HEALTH AND the docket unchanged. Because your www.regulations.gov. Submit both
HUMAN SERVICES comment will be made public, you are copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
Food and Drug Administration
comment does not include any name and contact information to be
[Docket No. FDA–2017–D–0040] confidential information that you or a made publicly available, you can
third party may not wish to be posted, provide this information on the cover
How To Prepare a Pre-Request for such as medical information, your or sheet and not in the body of your
Designation; Draft Guidance for anyone else’s Social Security number, or comments and you must identify this
Industry; Availability confidential business information, such information as ‘‘confidential.’’ Any
AGENCY: Food and Drug Administration, as a manufacturing process. Please note information marked as ‘‘confidential’’
HHS. that if you include your name, contact will not be disclosed except in
information, or other information that accordance with 21 CFR 10.20 and other
ACTION: Notice of availability. applicable disclosure law. For more
identifies you in the body of your
SUMMARY: The Food and Drug comments, that information will be information about FDA’s posting of
Administration (FDA or Agency) is posted on http://www.regulations.gov. comments to public dockets, see 80 FR
announcing the availability of a draft • If you want to submit a comment 56469, September 18, 2015, or access
guidance for industry entitled ‘‘How to with confidential information that you the information at: http://www.fda.gov/
Prepare a Pre-Request for Designation do not wish to be made available to the regulatoryinformation/dockets/
(Pre-RFD).’’ The purpose of this public, submit the comment as a default.htm.
guidance is to explain the Pre-RFD written/paper submission and in the Docket: For access to the docket to
process at the FDA Office of manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Combination Products (OCP), describe
received, go to http://
and help a sponsor understand the type Written/Paper Submissions www.regulations.gov and insert the
of information that the sponsor should
Submit written/paper submissions as docket number, found in brackets in the
include in a Pre-RFD, and assist
follows: heading of this document, into the
sponsors in obtaining a preliminary • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
assessment from FDA through the Pre- written/paper submissions): Division of and/or go to the Division of Dockets
RFD process. The Pre-RFD process is Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
available to provide informal, non- and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
binding feedback regarding the Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information
regulatory identity or classification of a • For written/paper comments collection issues to the Office of
human medical product as a drug, submitted to the Division of Dockets Management and Budget in the
device, biological product, or Management, FDA will post your following ways:
combination product. In addition, this comment, as well as any attachments, • Fax to the Office of Information and
informal process provides information except for information submitted, Regulatory Affairs, OMB, Attn: FDA
about a non-combination or marked and identified, as confidential, Desk Officer, FAX: 202–395–7285, or
combination product’s assignment to if submitted as detailed in email to oira_submission@omb.eop.gov.
the appropriate Agency Center (Center ‘‘Instructions.’’ All comments should be identified with
for Drug Evaluation and Research Instructions: All submissions received the title, ‘‘How to Prepare a Pre-Request
(CDER), Center for Devices and must include the Docket No. FDA– for Designation (Pre-RFD); Draft
Radiological Health (CDRH), or Center 2017–D–0040 for ‘‘How to Prepare a Pre- Guidance for Industry.’’
for Biologics Evaluation and Research Request for Designation (Pre-RFD); Draft Submit written requests for single
(CBER)) for premarket review and Guidance for Industry.’’ Received copies of the draft guidance document
regulation. This draft guidance is not comments will be placed in the docket entitled ‘‘How to Prepare a Pre-Request
final nor is it in effect at this time. and, except for those submitted as for Designation (Pre-RFD)’’ to the Office
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly of Combination Products, Food and
any guidance at any time (see 21 CFR viewable at http://www.regulations.gov Drug Administration, 10903 New
10.115(g)(5)), to ensure that the Agency or at the Division of Dockets Hampshire Ave., Bldg. 32, Rm. 5129,
considers your comment of this draft Management between 9 a.m. and 4 p.m., Silver Spring, MD 20993–0002. Send
guidance before it begins work on the Monday through Friday. one self-addressed adhesive label to
final version of the guidance, submit • Confidential Submissions—To assist that office in processing your
either electronic or written comments submit a comment with confidential request, or fax your request to 301–847–
on the draft guidance by April 13, 2017. information that you do not wish to be 8619. See the SUPPLEMENTARY
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Document Created: 2017-01-13 02:45:30
Document Modified: 2017-01-13 02:45:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; establishment of docket; request for comments. | |
| Dates | Submit either electronic or written comments by April 13, 2017. | |
| Contact | Nina L. Hunter, Office of Medical Products and Tobacco (OMPT), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2312, Silver Spring, MD 20993-0002, 301- 796-6171, FAX: 301-847-8514, [email protected] | |
| FR Citation | 82 FR 4349 |
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