83 FR 9001 - United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 42 (March 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 42 (March 2, 2018)
| Page Range | 9001-9003 | |
| FR Document | 2018-04256 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Notices] [Pages 9001-9003] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04256] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1112] United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Kobe, Japan, scheduled for June 4 through 7, 2018. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Kobe. DATES: The public meeting will be held on Friday, April 6, 2018, from 10 a.m. to 1 p.m. Submit either electronic or written comments on this public meeting by April 30, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (Great Room), Silver Spring, MD 20993-0002. The meeting will also be broadcast on the web, allowing participants to join in person OR via the web. For those who will attend in person, the entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For those who register to attend the public meeting remotely via the webcast, a link to access the webcast will be emailed 1 week in advance of the meeting. You may submit comments as follows. Please note that late, untimely, filed comments will not be considered. Electronic comments must be submitted on or before April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 30, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 in the sections below (see ``Written/Paper Submissions'' and ``Instructions''). [[Page 9002]] 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-2016-N-1112 for ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.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. FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301- 796-4548, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory requirements for safety and effectiveness. One of the goals of harmonization is to identify and then reduce regional differences in technical regulatory requirements for pharmaceutical products while preserving a consistently high standard for drug efficacy, safety, and quality. In 2015, the ICH was reformed to establish ICH as a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they join counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH observers and regulatory members. Expanded involvement is also anticipated from global regulated pharmaceutical industry parties, joining as ICH observers and industry members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development and their regulation. ICH guidelines are developed following a five-step process. In Step 1, experts from the different ICH regions work together to prepare a consensus draft of the Step 1 Technical Document. The Step 1 Technical Document is submitted to the ICH Assembly to request endorsement under Step 2a of the process. Step 2b is a ``Regulators only'' step in which the ICH regulatory members review the Step 2a Final Technical Document and take any actions, which might include revisions that they deem necessary, to develop the draft ``Guideline.'' Step 3 of the process begins with the public consultation process conducted by each of the ICH regulatory members in their respective regions, and this step concludes with completion and acceptance of any revisions that need to be made to the Step 2b draft guideline in response to public comments. Adoption of the new guideline occurs in Step 4. Following adoption, the harmonized guideline moves to Step 5, the final step of the process when it is implemented by each of the regulatory members in their respective regions. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions since 1990. More information on the current ICH process and structure can be found at the following website: http://www.ich.org/home.html. (FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.) II. Topics for Discussion at the Public Meeting The topics for discussion at this public meeting include the current guidelines under development under the ICH. These guidelines include the following: Topics Currently Under Regional Public Consultation (Step 3 of ICH Process): S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management E9(R1) Addendum: Statistical Principles for Clinical Trials Selected Topics Recently Finalized (Step 4 of ICH Process): E17 General Principles on Planning/Designing Multi-Regional Clinical Trials Electronic Standards and MedDRA (Medical Dictionary for Regulatory Activities): M2 Electronic Standards for the Transfer of Regulatory Information M8 Electronic Common Technical Document (eCTD) E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports M1 MedDRA Terminology Additional Ongoing Topics: [[Page 9003]] E19 Optimization of Safety Data Collection E8(R1) Revision on General Considerations for Clinical Trials E11A Pediatric Extrapolation E14/S7B Discussion Group on Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation M9 Biopharmaceutics Classification System-Based Biowaivers M10 Bioanalytical Method Validation S1(R1) Revision on Rodent Carcinogenicity Studies for Human Pharmaceuticals S5(R3) Revision on Detection of Toxicity to Reproduction for Human Pharmaceuticals Q3C(R7) Impurities: Guideline for Residual Solvents Q3D(R1) Guideline on Elemental Impurities III. Participating in the Public Meeting Registration: Persons interested in attending this public meeting must register online by April 3, 2018. To register for the public meeting, please visit the following website: https://ich_regional_consultation_2018.eventbrite.com. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by April 3, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 9:30 a.m. The agenda for the public meeting will be made available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm592065.htm approximately 2 weeks in advance of the meeting. If you need special accommodations due to a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later than March 23, 2018. Requests for Oral Presentations: If you wish to make a presentation during the public comment session, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later than March 23, 2018. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make presentations must be received by the close of registration on April 3, 2018. If selected for presentation, any presentation materials must be emailed to Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later than April 3, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Sign-up for making a public comment will also be available between 9 a.m. and 10 a.m. on the day of the meeting. Streaming Webcast of the Public Meeting: This public meeting will also be webcast. To register to attend via webcast, please visit the following website: https://ich_regional_consultation_2018.eventbrite.com. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Dated: February 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04256 Filed 3-1-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 9001
that reflects the amount of food II. Electronic Access Conference Center, Rm. 1503 (Great
customarily consumed and is expressed Persons with access to the internet Room), Silver Spring, MD 20993–0002.
in a common household measure that is may obtain the guidance at either The meeting will also be broadcast on
appropriate to the food. To comply with https://www.fda.gov/FoodGuidances or the web, allowing participants to join in
this requirement, manufacturers must https://www.regulations.gov. Use the person OR via the web. For those who
determine and label their food products FDA website listed in the previous will attend in person, the entrance for
with the appropriate label serving size sentence to find the most current the public meeting participants (non-
based on the amount of the product version of the guidance. FDA employees) is through Building 1
customarily consumed. where routine security check
Dated: February 27, 2018.
In the Federal Register of May 27, procedures will be performed. For
Leslie Kux, parking and security information, please
2016, we issued a final rule entitled
Associate Commissioner for Policy. refer to https://www.fda.gov/AboutFDA/
‘‘Food Labeling: Serving Sizes of Foods
[FR Doc. 2018–04283 Filed 3–1–18; 8:45 am] WorkingatFDA/BuildingsandFacilities/
That Can Reasonably Be Consumed at
One Eating Occasion; Dual-Column BILLING CODE 4164–01–P WhiteOakCampusInformation/
Labeling; Updating, Modifying, and ucm241740.htm. For those who register
Establishing Certain Reference Amounts to attend the public meeting remotely
DEPARTMENT OF HEALTH AND via the webcast, a link to access the
Customarily Consumed; Serving Size for
HUMAN SERVICES webcast will be emailed 1 week in
Breath Mints; and Technical
Amendments’’ (81 FR 34000). The final Food and Drug Administration advance of the meeting.
rule amends our regulations in You may submit comments as
§ 101.12(b) (21 CFR 101.12(b)) to update [Docket No. FDA–2016–N–1112]
follows. Please note that late, untimely,
or modify certain pre-existing RACCs, filed comments will not be considered.
United States Food and Drug
and to establish RACCs for new product Electronic comments must be submitted
Administration and Health Canada
categories. on or before April 30, 2018. The https://
Joint Regional Consultation on the
In the Federal Register of January 5, International Council for www.regulations.gov electronic filing
2017 (82 FR 1344), we announced the Harmonisation of Technical system will accept comments until
availability of a draft guidance for Requirements for Pharmaceuticals for midnight Eastern Time at the end of
industry entitled ‘‘Reference Amounts Human Use; Public Meeting; Request April 30, 2018. Comments received by
Customarily Consumed: List of Products for Comments mail/hand delivery/courier (for written/
for Each Product Category; Draft paper submissions) will be considered
Guidance for Industry’’ and gave AGENCY: Food and Drug Administration, timely if they are postmarked or the
interested parties an opportunity to HHS. delivery service acceptance receipt is on
submit comments by March 6, 2017, for ACTION: Notice of public meeting; or before that date.
us to consider before beginning work on request for comments.
the final version of the guidance. We Electronic Submissions
received several comments on the draft SUMMARY: The Food and Drug
Administration (FDA or Agency) is Submit electronic comments in the
guidance and have modified the following way:
content, where appropriate, for this final announcing a regional public meeting
guidance. Changes to the guidance entitled ‘‘U.S. Food and Drug • Federal eRulemaking Portal:
include the addition of flavored nut Administration and Health Canada Joint https://www.regulations.gov. Follow the
butter spreads (e.g., cocoa, cookie, and Regional Consultation on the instructions for submitting comments.
coffee flavored) as an example in the International Council for Harmonisation Comments submitted electronically,
‘‘Nut and seed butters, pastes, or of Technical Requirements for including attachments, to https://
creams’’ product category. In the Pharmaceuticals for Human Use (ICH).’’ www.regulations.gov will be posted to
The purpose of the public meeting is to the docket unchanged. Because your
Federal Register of November 2, 2016,
provide information and solicit public comment will be made public, you are
we published a Request for Information
input on the current activities of the solely responsible for ensuring that your
and Comments requesting information
ICH, as well as the upcoming ICH comment does not include any
and comments on the appropriate
Assembly Meeting and the Expert confidential information that you or a
product category and RACC for flavored
Working Group Meetings in Kobe, third party may not wish to be posted,
nut butter spreads (e.g., cocoa, cookie,
Japan, scheduled for June 4 through 7, such as medical information, your or
and coffee flavored) (81 FR 76323).
2018. The topics to be addressed at the anyone else’s Social Security number, or
Based upon the information and
public meeting are the current ICH confidential business information, such
comments received, and our own
guideline topics under development as a manufacturing process. Please note
assessment, we have determined that
that will be discussed at the that if you include your name, contact
flavored nut butter spreads (e.g., cocoa, forthcoming ICH Assembly Meeting in
cookie, and coffee flavored) are information, or other information that
Kobe. identifies you in the body of your
comparable to nut butters and belong in
the ‘‘Nut and seed butters, pastes, or DATES: The public meeting will be held comments, that information will be
creams’’ product category with a RACC on Friday, April 6, 2018, from 10 a.m. posted on https://www.regulations.gov.
of two tablespoons. In addition to this to 1 p.m. Submit either electronic or • If you want to submit a comment
daltland on DSKBBV9HB2PROD with NOTICES
and other clarifying substantive changes written comments on this public with confidential information that you
that we made to the guidance, we made meeting by April 30, 2018. See the do not wish to be made available to the
editorial changes to improve clarity and SUPPLEMENTARY INFORMATION section for public, submit the comment as a
to help ensure consistency with registration date and information. written/paper submission and in the
§ 101.12(b). The guidance announced in ADDRESSES: The public meeting will be manner detailed in the sections below
this notice finalizes the draft guidance held at FDA’s White Oak Campus, (see ‘‘Written/Paper Submissions’’ and
dated January 2017. 10903 New Hampshire Ave., Bldg. 31 ‘‘Instructions’’).
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![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 9003
• E19 Optimization of Safety Data close of registration on April 3, 2018. If small entity compliance guide (SECG) is
Collection selected for presentation, any intended to help small entities comply
• E8(R1) Revision on General presentation materials must be emailed with a final rule we issued in the
Considerations for Clinical Trials to Amanda Roache (see FOR FURTHER Federal Register of May 27, 2016,
• E11A Pediatric Extrapolation INFORMATION CONTACT) no later than entitled ‘‘Food Labeling: Serving Sizes
• E14/S7B Discussion Group on April 3, 2018. No commercial or of Foods That Can Reasonably Be
Clinical and Nonclinical Evaluation of promotional material will be permitted Consumed at One Eating Occasion;
QT/QTc Interval Prolongation to be presented or distributed at the Dual-Column Labeling; Updating,
• M9 Biopharmaceutics Classification public meeting. Sign-up for making a Modifying, and Establishing Certain
System-Based Biowaivers public comment will also be available Reference Amounts Customarily
• M10 Bioanalytical Method Validation between 9 a.m. and 10 a.m. on the day Consumed; Serving Size for Breath
• S1(R1) Revision on Rodent of the meeting. Mints; and Technical Amendments.’’
Carcinogenicity Studies for Human Streaming Webcast of the Public The final rule is designed to ensure that
Pharmaceuticals Meeting: This public meeting will also serving sizes are based on more recent
• S5(R3) Revision on Detection of be webcast. To register to attend via consumption data and that consumers
Toxicity to Reproduction for Human webcast, please visit the following have serving size information on the
Pharmaceuticals website: https://ich_regional_ Nutrition Facts label that will assist
• Q3C(R7) Impurities: Guideline for consultation_2018.eventbrite.com. If them in maintaining healthy dietary
Residual Solvents you have never attended a Connect Pro practices.
• Q3D(R1) Guideline on Elemental event before, test your connection at DATES: The announcement of the
Impurities https://collaboration.fda.gov/common/ guidance is published in the Federal
III. Participating in the Public Meeting help/en/support/meeting_test.htm. To Register on March 2, 2018.
Registration: Persons interested in get a quick overview of the Connect Pro ADDRESSES: You may submit either
attending this public meeting must program, visit https://www.adobe.com/ electronic or written comments on
register online by April 3, 2018. To go/connectpro_overview. FDA has Agency guidances at any time as
register for the public meeting, please verified the website addresses in this follows:
visit the following website: https://ich_ document, as of the date this document
publishes in the Federal Register, but Electronic Submissions
regional_consultation_
2018.eventbrite.com. Please provide websites are subject to change over time. Submit electronic comments in the
complete contact information for each Dated: February 26, 2018. following way:
• Federal eRulemaking Portal:
attendee, including name, title, Leslie Kux,
https://www.regulations.gov. Follow the
affiliation, address, email, and Associate Commissioner for Policy. instructions for submitting comments.
telephone. [FR Doc. 2018–04256 Filed 3–1–18; 8:45 am] Comments submitted electronically,
Registration is free and based on BILLING CODE 4164–01–P including attachments, to https://
space availability, with priority given to
www.regulations.gov will be posted to
early registrants. Persons interested in
the docket unchanged. Because your
attending this public meeting must DEPARTMENT OF HEALTH AND comment will be made public, you are
register by April 3, 2018, midnight HUMAN SERVICES solely responsible for ensuring that your
Eastern Time. Early registration is
comment does not include any
recommended because seating is Food and Drug Administration
confidential information that you or a
limited; therefore, FDA may limit the
[Docket No. FDA–2004–N–0258] third party may not wish to be posted,
number of participants from each such as medical information, your or
organization. If time and space permit, Food Labeling: Serving Sizes of Foods anyone else’s Social Security number, or
onsite registration on the day of the That Can Reasonably Be Consumed at confidential business information, such
public meeting will be provided One Eating Occasion; Dual-Column as a manufacturing process. Please note
beginning at 9:30 a.m. Labeling; Updating, Modifying, and that if you include your name, contact
The agenda for the public meeting Establishing Certain Reference information, or other information that
will be made available on the internet Amounts Customarily Consumed; identifies you in the body of your
at https://www.fda.gov/Drugs/ Serving Size for Breath Mints; and comments, that information will be
NewsEvents/ucm592065.htm Technical Amendments—Small Entity posted on https://www.regulations.gov.
approximately 2 weeks in advance of Compliance Guide; Availability • If you want to submit a comment
the meeting. with confidential information that you
If you need special accommodations AGENCY: Food and Drug Administration, do not wish to be made available to the
due to a disability, please contact HHS. public, submit the comment as a
Amanda Roache (see FOR FURTHER ACTION: Notification of availability. written/paper submission and in the
INFORMATION CONTACT) no later than manner detailed (see ‘‘Written/Paper
March 23, 2018. SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
Requests for Oral Presentations: If you Administration (FDA or we) is
wish to make a presentation during the announcing the availability of a Written/Paper Submissions
public comment session, please contact guidance for industry entitled ‘‘Food Submit written/paper submissions as
Amanda Roache (see FOR FURTHER Labeling: Serving Sizes of Foods That follows:
daltland on DSKBBV9HB2PROD with NOTICES
INFORMATION CONTACT) no later than Can Reasonably Be Consumed at One • Mail/Hand Delivery/Courier (for
March 23, 2018. Individuals and Eating Occasion; Dual-Column Labeling; written/paper submissions): Dockets
organizations with common interests are Updating, Modifying, and Establishing Management Staff (HFA–305), Food and
urged to consolidate or coordinate their Certain Reference Amounts Customarily Drug Administration, 5630 Fishers
presentations, and request time for a Consumed; Serving Size for Breath Lane, Rm. 1061, Rockville, MD 20852.
joint presentation. All requests to make Mints; and Technical Amendments— • For written/paper comments
presentations must be received by the Small Entity Compliance Guide.’’ The submitted to the Dockets Management
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Document Created: 2018-03-01 23:56:15
Document Modified: 2018-03-01 23:56:15
| 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 of public meeting; request for comments. | |
| Dates | The public meeting will be held on Friday, April 6, 2018, from 10 a.m. to 1 p.m. Submit either electronic or written comments on this public meeting by April 30, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301- 796-4548, [email protected] | |
| FR Citation | 83 FR 9001 |
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