82 FR 45856 - Equivalence of Complex Products; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45856-45858 | |
| FR Document | 2017-21018 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45856-45858] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21018] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5776] Equivalence of Complex Products; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing.'' The purpose of the workshop is to share FDA's current experiences on the evaluation and characterization of critical quality attributes for complex drug substances (e.g. polymeric and naturally derived substances and peptides) and formulations (e.g. liposomes, emulsions, suspensions, and polymeric inserts); discuss current and future innovative approaches for the development and regulatory review of equivalent complex drug products; obtain input from various stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products; and request comments on these topics. DATES: The public workshop will be held on October 6, 2017, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by November 10, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 B+C), Silver Spring, MD 20993-0002. Entrance for the public workshop 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. 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 November 10, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 10, 2017. 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 (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-N-5776 for ``Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing.'' 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 [[Page 45857]] 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: Xiaohui Jiang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4716, Silver Spring, MD 20993, 240-402- 4468, [email protected]; or Darby Kozak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4710, Silver Spring, MD 20993, 240-402- 2647, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In July 2012, Congress passed the Generic Drug User Fee Amendments (GDUFA) (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and reduce costs to industry. To support this goal, FDA agreed in the GDUFA commitment letter to work with industry and interested stakeholders on identifying regulatory science research priorities specific to generic drugs for each fiscal year covered by GDUFA. The commitment letter outlines FDA's performance goals and procedures under the GDUFA program for the years 2012 to 2017. The commitment letter can be found at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf. In the Regulatory Science section of the GDUFA Commitment Letter, FDA outlined its plans to advance regulatory science, including research to support the development of guidance and policy that clarifies the ANDA pathway for complex drug products. This regulatory science research includes but is not limited to: (1) Assessing innovative analytical methods and procedures for characterizing the active ingredient sameness and pharmaceutical equivalence of complex drug substances, such as peptides and naturally derived substances, and (2) developing and evaluating new techniques to measure the critical quality attributes of complex formulations, such as liposomes, emulsions, suspensions, and polymeric inserts, with the goal of providing robust in vitro alternatives to in vivo bioequivalence studies, and (3) developing and evaluating critical quality attributes for complex drug-device combination products. To facilitate communication of recent advances in this regulatory science, including those supported by GDUFA funds, FDA plans to hold a public workshop on new analytical methods and assessment criteria for demonstrating the equivalence of complex drug substances and formulations. II. Topics for Discussion at the Public Workshop The purposes of the workshop are to: 1. Share FDA's current experiences on the evaluation and characterization of critical quality attributes for complex drug substances (e.g. polymeric and naturally derived substances and peptides) and formulations (e.g. liposomes, emulsions, suspensions, and polymeric inserts); 2. Discuss current and future innovative approaches for the development and regulatory review of equivalent complex drug products; 3. Obtain input from various stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products; and 4. Request comments on these topics. The scope of the workshop covers the current status, from an academic, industry, and regulatory perspective, of methods for assessing the pharmaceutical equivalence of complex drug substances and the bioequivalence of complex generic drug product formulations. Complex drug substances and formulations present unique development and regulatory challenges for generic drugs as establishing equivalence may not be straightforward by conventional practices. New and innovative analytical and statistical approaches may overcome these hurdles and thereby reduce product development time and cost, and inform regulatory decisions. For example, new high resolution analytical methods and advanced statistical models can provide better understanding of the complex structure, and greater confidence of structural sameness, needed for demonstrating the pharmaceutical equivalence of a generic peptide, carbohydrate, or other naturally- sourced complex drug substance. In the same fashion, new and innovative in vitro characterization methods can provide an accurate measure of the critical quality attributes of generic liposomal, emulsion, suspension, or polymeric matrix drug products. These in vitro tests can often be used to support a demonstration of bioequivalence, in lieu of in vivo studies, depending, among other factors, on the sensitivity, robustness and/or correlation of these in vitro tests to the product performance. The focus of this public workshop is on the evaluation of new analytical and statistical methods for demonstrating equivalence of complex products, including discussing the areas in which these methods can contribute significantly, how and when the methods should be conducted and evaluated, and inherent scientific challenges. Public input will improve FDA's current understanding of present and future methods available for evaluating complex product equivalence. The knowledge gained from, and consensus reached, through this workshop will be summarized and disseminated to the scientific community by publication(s). FDA seeks input from the public on when, where, and how to utilize new methods for development of equivalent complex drug products and in the regulatory review of pharmaceutical equivalence and bioequivalence. Specific topics to be addressed include: 1. Identifying the areas in which new in vitro analytical and statistical methods can contribute to the development of equivalent complex products and regulatory evaluation of pharmaceutical equivalence and bioequivalence; 2. Discussing how in vitro testing for demonstrating complex product equivalence should be conducted and evaluated; and 3. Addressing the scientific challenges in assessing critical quality attributes of complex products and in developing new analytical methods for demonstrating complex product equivalence. [[Page 45858]] III. Participating in the Public Workshop Registration: Persons interested in attending this public workshop must register online at https://survey.co1.qualtrics.com/jfe/form/SV_6X23XS8WXHtfWAJ. 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 workshop must register by October 2, 2017, midnight, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact Xiaohui Jiang (see FOR FURTHER INFORMATION CONTACT) no later than October 2, 2017. Streaming Webcast of the public workshop: This public workshop will also be webcast. A live webcast of this workshop will be viewable at https://collaboration.fda.gov/complexgenericdrugs/ on the day of the workshop. 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 Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the Internet at https://www.fda.gov/drugs/newsevents/ucm552461.htm. Dated: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21018 Filed 9-29-17; 8:45 am] BILLING CODE 4164-01-P
![45856 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices
information found in FDA regulations. Substances and Formulations: Advances solely responsible for ensuring that your
These collections of information are in Characterization and In Vitro comment does not include any
subject to review by the Office of Testing.’’ The purpose of the workshop confidential information that you or a
Management and Budget (OMB) under is to share FDA’s current experiences on third party may not wish to be posted,
the Paperwork Reduction Act of 1995 the evaluation and characterization of such as medical information, your or
(44 U.S.C. 3501–3520). The collections critical quality attributes for complex anyone else’s Social Security number, or
of information in 21 CFR part 807, drug substances (e.g. polymeric and confidential business information, such
subpart E, have been approved under naturally derived substances and as a manufacturing process. Please note
OMB control number 0910–0120, the peptides) and formulations (e.g. that if you include your name, contact
collections of information in 21 CFR liposomes, emulsions, suspensions, and information, or other information that
part 820 have been approved under polymeric inserts); discuss current and identifies you in the body of your
OMB control number 0910–0073, and future innovative approaches for the comments, that information will be
the collections of information in 21 CFR development and regulatory review of posted on https://www.regulations.gov.
part 801 have been approved under equivalent complex drug products; • If you want to submit a comment
OMB control number 0910–0485. The obtain input from various stakeholders with confidential information that you
collections of information in 21 CFR on how to conduct and assess critical do not wish to be made available to the
parts 1002 and 1010 are approved under quality attribute measurements to public, submit the comment as a
OMB control number 0910–0025. demonstrate equivalence of complex written/paper submission and in the
drug products; and request comments manner detailed (see ‘‘Written/Paper
V. References Submissions’’ and ‘‘Instructions’’).
on these topics.
The following references are on DATES: The public workshop will be Written/Paper Submissions
display in the Dockets Management held on October 6, 2017, from 8:30 a.m.
Staff (see ADDRESSES) and are available Submit written/paper submissions as
to 4:30 p.m. Submit either electronic or follows:
for viewing by interested persons written comments on this public
between 9 a.m. and 4 p.m., Monday • Mail/Hand delivery/Courier (for
workshop by November 10, 2017. See written/paper submissions): Dockets
through Friday; they are also available the SUPPLEMENTARY INFORMATION section
electronically at https:// Management Staff (HFA–305), Food and
for registration date and information. Drug Administration, 5630 Fishers
www.regulations.gov. FDA has verified
ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
the Web site address, as of the date this
be held at FDA White Oak Campus, • For written/paper comments
document publishes in the Federal
10903 New Hampshire Ave., Bldg. 31 submitted to the Dockets Management
Register, but Web sites are subject to
Conference Center, the Great Room (Rm. Staff, FDA will post your comment, as
change over time.
1503 B+C), Silver Spring, MD 20993– well as any attachments, except for
1. FDA Guidance, ‘‘Information for 0002. Entrance for the public workshop information submitted, marked and
Manufacturers Seeking Marketing Clearance participants (non-FDA employees) is identified, as confidential, if submitted
of Diagnostic Ultrasound Systems and
through Building 1 where routine as detailed in ‘‘Instructions.’’
Transducers.’’ Available at: https://
security check procedures will be Instructions: All submissions received
www.fda.gov/downloads/UCM070911.pdf.
2. FDA, ‘‘Information for Industry.’’ performed. For parking and security must include the Docket No. FDA–
Available at: https://www.fda.gov/ information, please refer to https:// 2017–N–5776 for ‘‘Demonstrating
RadiationEmittingProducts/Radiation www.fda.gov/AboutFDA/Working Equivalence of Generic Complex Drug
EmittingProductsandProcedures/Medical atFDA/BuildingsandFacilities/WhiteOak Substances and Formulations: Advances
Imaging/ucm115357.htm CampusInformation/ucm241740.htm. in Characterization and In Vitro
Dated: September 22, 2017. You may submit comments as Testing.’’ Received comments, those
Leslie Kux, follows. Please note that late, untimely filed in a timely manner (see
filed comments will not be considered. ADDRESSES), will be placed in the docket
Associate Commissioner for Policy.
Electronic comments must be submitted and, except for those submitted as
[FR Doc. 2017–21077 Filed 9–29–17; 8:45 am]
on or before November 10, 2017. The ‘‘Confidential Submissions,’’ publicly
BILLING CODE 4164–01–P
https://www.regulations.gov electronic viewable at https://www.regulations.gov
filing system will accept comments or at the Dockets Management Staff
until midnight Eastern Time at the end between 9 a.m. and 4 p.m., Monday
DEPARTMENT OF HEALTH AND
of November 10, 2017. Comments through Friday.
HUMAN SERVICES • Confidential Submissions—To
received by mail/hand delivery/courier
Food and Drug Administration (for written/paper submissions) will be submit a comment with confidential
considered timely if they are information that you do not wish to be
[Docket No. FDA–2017–N–5776] postmarked or the delivery service made publicly available, submit your
acceptance receipt is on or before that comments only as a written/paper
Equivalence of Complex Products; submission. You should submit two
date.
Public Workshop; Request for copies total. One copy will include the
Comments Electronic Submissions information you claim to be confidential
AGENCY: Food and Drug Administration, Submit electronic comments in the with a heading or cover note that states
HHS. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice of public workshop;
request for comments. https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
SUMMARY: The Food and Drug Comments submitted electronically, its consideration of comments. The
Administration (FDA, the Agency, or including attachments, to https:// second copy, which will have the
we) is announcing the following public www.regulations.gov will be posted to claimed confidential information
workshop entitled ‘‘Demonstrating the docket unchanged. Because your redacted/blacked out, will be available
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![45858 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices
III. Participating in the Public DEPARTMENT OF HEALTH AND Written/Paper Submissions
Workshop HUMAN SERVICES Submit written/paper submissions as
Registration: Persons interested in follows:
Food and Drug Administration • Mail/Hand delivery/Courier (for
attending this public workshop must
[Docket No. FDA–2017–N–2837] written/paper submissions): Dockets
register online at https://
Management Staff (HFA–305), Food and
survey.co1.qualtrics.com/jfe/form/SV_ Electronic Study Data Submission; Drug Administration, 5630 Fishers
6X23XS8WXHtfWAJ. Please provide Data Standards; Support for Analysis Lane, Rm. 1061, Rockville, MD 20852.
complete contact information for each Data Model Implementation Guide • For written/paper comments
attendee, including name, title, Version 1.1 submitted to the Dockets Management
affiliation, address, email, and Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration,
telephone. well as any attachments, except for
HHS.
Registration is free and based on ACTION: Notice. information submitted, marked and
space availability, with priority given to identified, as confidential, if submitted
early registrants. Persons interested in SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
attending this public workshop must Administration (FDA) Center for Drug Instructions: All submissions received
register by October 2, 2017, midnight, Evaluation and Research (CDER) is must include the Docket No. FDA–
Eastern Time. Early registration is announcing support for version 1.1 of 2017–N–2837 for ‘‘Electronic Study
recommended because seating is Clinical Data Interchange Standards Data Submission; Data Standards;
limited; therefore, FDA may limit the Consortium (CDISC), Analysis Data Support for Analysis Data Model
Model Implementation Guide (ADaM IG Implementation Guide Version 1.1.’’
number of participants from each
V1.1), an update to the FDA Data Received comments will be placed in
organization.
Standards Catalog (Catalog). (See http:// the docket and, except for those
If you need special accommodations www.fda.gov/forindustry/ submitted as ‘‘Confidential
due to a disability, please contact datastandards/studydatastandards/ Submissions,’’ publicly viewable at
Xiaohui Jiang (see FOR FURTHER default.htm). ADaM IG V1.1 has been https://www.regulations.gov or at the
INFORMATION CONTACT) no later than available from CDISC (www.cdisc.org) Dockets Management Staff between 9
October 2, 2017. since February 12, 2016. FDA is a.m. and 4 p.m., Monday through
Streaming Webcast of the public encouraging sponsors and applicants to Friday.
workshop: This public workshop will use ADaM IG V1.1 in investigational • Confidential Submissions—To
also be webcast. A live webcast of this study data provided in regulatory submit a comment with confidential
submissions to CDER. information that you do not wish to be
workshop will be viewable at https://
DATES: Submit either electronic or made publicly available, submit your
collaboration.fda.gov/complex
written comments at any time. comments only as a written/paper
genericdrugs/ on the day of the
ADDRESSES: You may submit comments submission. You should submit two
workshop. copies total. One copy will include the
as follows:
If you have never attended a Connect information you claim to be confidential
Pro event before, test your connection at Electronic Submissions with a heading or cover note that states
https://collaboration.fda.gov/common/ Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
help/en/support/meeting_test.htm. To following way: CONFIDENTIAL INFORMATION.’’ The
get a quick overview of the Connect Pro • Federal eRulemaking Portal: Agency will review this copy, including
program, visit https://www.adobe.com/ https://www.regulations.gov. Follow the the claimed confidential information, in
go/connectpro_overview. FDA has instructions for submitting comments. its consideration of comments. The
verified the Web site addresses in this Comments submitted electronically, second copy, which will have the
document, as of the date this document including attachments, to https:// claimed confidential information
publishes in the Federal Register, but www.regulations.gov will be posted to redacted/blacked out, will be available
Web sites are subject to change over the docket unchanged. Because your for public viewing and posted on
time. comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Division of Dockets
Transcripts: Please be advised that as comment does not include any Management. If you do not wish your
soon as a transcript of the public confidential information that you or a name and contact information to be
workshop is available, it will be third party may not wish to be posted, made publicly available, you can
accessible at https:// such as medical information, your or provide this information on the cover
www.regulations.gov. It may be viewed anyone else’s Social Security number, or sheet and not in the body of your
at the Dockets Management Staff (see confidential business information, such comments and you must identify this
ADDRESSES). A link to the transcript will as a manufacturing process. Please note information as ‘‘confidential.’’ Any
also be available on the Internet at that if you include your name, contact information marked as ‘‘confidential’’
https://www.fda.gov/drugs/newsevents/ information, or other information that will not be disclosed except in
ucm552461.htm. identifies you in the body of your accordance with 21 CFR 10.20 and other
Dated: September 26, 2017. comments, that information will be applicable disclosure law. For more
information about FDA’s posting of
sradovich on DSK3GMQ082PROD with NOTICES
posted on https://www.regulations.gov.
Anna K. Abram, • If you want to submit a comment comments to public dockets, see 80 FR
Deputy Commissioner for Policy, Planning, with confidential information that you 56469, September 18, 2015, or access
Legislation, and Analysis. do not wish to be made available to the the information at: https://www.gpo.gov/
[FR Doc. 2017–21018 Filed 9–29–17; 8:45 am] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
BILLING CODE 4164–01–P written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
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Document Created: 2017-09-30 04:41:38
Document Modified: 2017-09-30 04:41:38
| 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 workshop; request for comments. | |
| Dates | The public workshop will be held on October 6, 2017, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by November 10, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Xiaohui Jiang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4716, Silver Spring, MD 20993, 240-402- 4468, [email protected]; or Darby Kozak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4710, Silver Spring, MD 20993, 240-402- 2647, [email protected] | |
| FR Citation | 82 FR 45856 |
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