82 FR 60201 - New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60201-60203 | |
| FR Document | 2017-27279 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Notices] [Pages 60201-60203] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27279] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6716] New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug 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 ``New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products.'' The purposes of the workshop are to present the outcomes from the research projects conducted under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research Program; discuss how regulatory science initiatives have helped address regulatory science knowledge gaps by providing insights on factors that influence the performance of generic orally inhaled and nasal drug products (OINDPs); share the Agency's experience on the utility of novel analytical tools and methods developed under the regulatory science initiative for generic OINDP product development and bioequivalence assessments; and obtain input from the public on what, when, where, and how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs) for complex OINDPs. DATES: The public workshop will be held on January 9, 2018, from 8:30 a.m. to 4:30 p.m. Individuals who wish to attend the workshop must register by December 30, 2017. Submit either electronic or written comments on this public workshop by February 14, 2018. 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 February 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 14, 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 (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-6716 for ``New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products.'' 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. [[Page 60202]] FOR FURTHER INFORMATION CONTACT: Renishkumar Delvadia, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4704, Silver Spring, MD 20993, 240-402- 7979, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Regulatory Science Enhancements section of the GDUFA Reauthorization Performance Goals and Program Enhancement Fiscal Years 2018-2022 (GDUFA II Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf) FDA committed to ``conduct internal and external research to support fulfilment of submission review and pre-ANDA commitments.'' This continues commitments made in the GDUFA Program Performance Goals and Procedures for fiscal years 2013 through 2017 (GDUFA I Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf). For complex OINDPs, this research is intended to support the development of scientific guidance and Agency policy to clarify the ANDA pathway for OINDPs and aid our understanding about the critical product attributes relevant for in vivo performance of OINDPs. This work has led to the development of tools beneficial to both industry and FDA for developing and evaluating generic OINDPs. This regulatory science research includes, but is not limited to, the following: (1) Identification of critical formulation and device attributes of generic OINDPs; (2) development of clinically relevant in vitro tools for prediction of in vivo regional drug deposition and dissolution from OINDPs; (3) development of computational fluid dynamic (CFD) and physiologically- based pharmacokinetic (PBPK) models for prediction of the local and systemic exposure of drugs delivered through OINDPs and to assess their applicability in generic OINDP development programs; and (4) identification, validation, and standardization of novel techniques that can be used for future bioequivalence assessments for generic OINDPs. Since its commencement in 2012, the GDUFA Regulatory Science Research Program has continuously aided our understanding about the critical product attributes that are relevant for in vivo performance of OINDPs, and has led to the development of tools beneficial to both industry and FDA for developing and assessing generic OINDPs. Several external and internal research projects have been initiated under the GDUFA Regulatory Science Research Program. The outcomes from these research studies have provided valuable insight about the factors influencing the performance of OINDPs and have helped the Agency fill regulatory science gaps in this area. For instance, advanced modeling tools developed under this initiative, such as CFD and PBPK, can provide insights about patient-device interactions and information about both local and systemic bioavailability, which can better characterize critical device and formulation attributes to further our understanding of generic drug-device combination products. Clinically relevant mouth-throat and nasal models are another example of this research which have shown good in vivo correlations in predicting regional drug deposition; these physical models allow us to predict the impact of certain performance characteristics of OINDPs on regional drug deposition in a realistic manner, potentially without the need for conducting comparative clinical endpoint studies. Similarly, Morphologically Directed Raman Spectroscopy (MDRS), a novel particle sizing method explored under the initiative, has shown promise in differentiating nasal suspension formulations of different drug particle sizes, and has opened the possibility of a new regulatory pathway for the approval of generic nasal suspension products without the need to conduct a comparative clinical endpoint study. Another research outcome developed under the science initiative for OINDPs has been work involving in-vitro dissolution methods, which are providing insights on the bridge between local drug deposition and its downstream systemic bioavailability. Our enhanced understanding about OINDPs from these regulatory science-based initiatives have informed us during the development of product-specific guidances for OINDPs, resulting in the publication of more than 39 product-specific guidance documents since the implementation of GDUFA in 2012. To enhance communication of recent advances, including those supported by GDUFA funds, FDA plans to hold a public workshop on new analytical methods and assessment criteria for characterization of OINDPs. II. Purpose and Scope of the Workshop The purposes of the workshop are as follows: 1. To present the outcomes from the research projects initiated under the GDUFA Regulatory Science Research Program; 2. To discuss how regulatory science initiatives have helped address regulatory science gaps by providing insight on factors that influence the performance of OINDPs; 3. To share the Agency's experience on the utility of novel analytical tools and methods developed under the regulatory science initiative for OINDP product development and bioequivalence assessments; and 4. To obtain input from the public on what, when, where, and how analytical methods and procedures should be applied in the development and review of complex OINDP ANDAs for therapeutic equivalence. The scope of the workshop covers the current status of methods for characterization and bioequivalence evaluation of generic OINDPs. The focus of this public workshop is on the evaluation of these new methods for characterizing and demonstrating therapeutic equivalence of OINDPs, including discussing the areas in which these methods may significantly contribute to generic product development and regulatory understanding, how and under what conditions the methods should be conducted and evaluated, and inherent scientific challenges with this complex class of products. Public input will improve FDA's current understanding of present and future methods available for evaluating OINDP therapeutic equivalence. The knowledge gained through this workshop discussion will be summarized and disseminated to the scientific community by publication(s). III. Scope of Public Input Requested FDA seeks input from the public on when, where, and how to utilize new methods for development of generic OINDPs and in the regulatory review of bioequivalence. Specific topics to be addressed include: 1. Identifying the areas in which new in vitro and computational methods can contribute to the development of generic OINDPs; 2. Discussing how in vitro testing for demonstrating OINDP therapeutic equivalence should be conducted and evaluated; and 3. Addressing the scientific challenges in assessing critical quality attributes of OINDPs and in developing new [[Page 60203]] methods for demonstrating OINDP therapeutic equivalence. Registration: Persons interested in attending this public workshop must register online by December 30, 2017, by going to https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. The workshop agenda and other background materials will be available approximately 2 weeks before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. The agenda will include time for questions and answers throughout the day and for general comments and questions from the audience following panel discussions. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by December 30, 2017, 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 workshop will be provided beginning at 8:30 a.m. If you need special accommodations due to a disability, please contact Renishkumar Delvadia no later than December 30, 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/r19djs3yfsf/ on the day of the workshop. A video record of the workshop will be available at the same web address for 1 year. 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: December 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27279 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices 60201
comments and suggestions submitted 10903 New Hampshire Ave., Bldg. 31 • For written/paper comments
within 60 days of this publication. Conference Center, the Great Room (Rm. submitted to the Dockets Management
1503 B+C), Silver Spring, MD 20993– Staff, FDA will post your comment, as
Robert Sargis,
0002. Entrance for the public workshop well as any attachments, except for
Reports Clearance Officer.
participants (non-FDA employees) is information submitted, marked and
[FR Doc. 2017–27306 Filed 12–18–17; 8:45 am] through Building 1, where routine identified, as confidential, if submitted
BILLING CODE 4184–01–P security check procedures will be as detailed in ‘‘Instructions.’’
performed. For parking and security Instructions: All submissions received
information, please refer to https:// must include the Docket No. FDA–
DEPARTMENT OF HEALTH AND www.fda.gov/AboutFDA/ 2017–N–6716 for ‘‘New Insights for
HUMAN SERVICES WorkingatFDA/BuildingsandFacilities/ Product Development and
WhiteOakCampusInformation/ Bioequivalence Assessments of Generic
Food and Drug Administration
ucm241740.htm. Orally Inhaled and Nasal Drug
[Docket No. FDA–2017–N–6716] You may submit comments as Products.’’ Received comments, those
follows. Please note that late, untimely filed in a timely manner (see
New Insights for Product Development filed comments will not be considered. ADDRESSES), will be placed in the docket
and Bioequivalence Assessments of Electronic comments must be submitted and, except for those submitted as
Generic Orally Inhaled and Nasal Drug on or before February 14, 2018. The ‘‘Confidential Submissions,’’ publicly
Products; Public Workshop; Request https://www.regulations.gov electronic viewable at https://www.regulations.gov
for Comments filing system will accept comments or at the Dockets Management Staff
AGENCY: Food and Drug Administration, until midnight Eastern Time at the end between 9 a.m. and 4 p.m., Monday
HHS. of February 14, 2018. Comments through Friday.
received by mail/hand delivery/courier • Confidential Submissions—To
ACTION: Notice of public workshop;
(for written/paper submissions) will be submit a comment with confidential
request for comments.
considered timely if they are information that you do not wish to be
SUMMARY: The Food and Drug postmarked or the delivery service made publicly available, submit your
Administration (FDA, the Agency, or acceptance receipt is on or before that comments only as a written/paper
we) is announcing the following public date. submission. You should submit two
workshop entitled ‘‘New Insights for copies total. One copy will include the
Product Development and Electronic Submissions information you claim to be confidential
Bioequivalence Assessments of Generic Submit electronic comments in the with a heading or cover note that states
Orally Inhaled and Nasal Drug following way: ‘‘THIS DOCUMENT CONTAINS
Products.’’ The purposes of the • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
workshop are to present the outcomes https://www.regulations.gov. Follow the Agency will review this copy, including
from the research projects conducted instructions for submitting comments. the claimed confidential information, in
under the Generic Drug User Fee Comments submitted electronically, its consideration of comments. The
Amendments (GDUFA) Regulatory including attachments, to https:// second copy, which will have the
Science Research Program; discuss how www.regulations.gov will be posted to claimed confidential information
regulatory science initiatives have the docket unchanged. Because your redacted/blacked out, will be available
helped address regulatory science comment will be made public, you are for public viewing and posted on
knowledge gaps by providing insights solely responsible for ensuring that your https://www.regulations.gov. Submit
on factors that influence the comment does not include any both copies to the Dockets Management
performance of generic orally inhaled confidential information that you or a Staff. If you do not wish your name and
and nasal drug products (OINDPs); third party may not wish to be posted, contact information to be made publicly
share the Agency’s experience on the such as medical information, your or available, you can provide this
utility of novel analytical tools and anyone else’s Social Security number, or information on the cover sheet and not
methods developed under the regulatory confidential business information, such in the body of your comments and you
science initiative for generic OINDP as a manufacturing process. Please note must identify this information as
product development and that if you include your name, contact ‘‘confidential.’’ Any information marked
bioequivalence assessments; and obtain information, or other information that as ‘‘confidential’’ will not be disclosed
input from the public on what, when, identifies you in the body of your except in accordance with 21 CFR 10.20
where, and how analytical methods and comments, that information will be and other applicable disclosure law. For
procedures should be applied in the posted on https://www.regulations.gov. more information about FDA’s posting
development and review of abbreviated • If you want to submit a comment of comments to public dockets, see 80
new drug applications (ANDAs) for with confidential information that you FR 56469, September 18, 2015, or access
complex OINDPs. do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
DATES: The public workshop will be
written/paper submission and in the 23389.pdf.
held on January 9, 2018, from 8:30 a.m. Docket: For access to the docket to
to 4:30 p.m. Individuals who wish to manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). read background documents or the
attend the workshop must register by electronic and written/paper comments
December 30, 2017. Submit either Written/Paper Submissions received, go to https://
sradovich on DSK3GMQ082PROD with NOTICES
electronic or written comments on this Submit written/paper submissions as www.regulations.gov and insert the
public workshop by February 14, 2018. follows: docket number, found in brackets in the
See the SUPPLEMENTARY INFORMATION • Mail/Hand delivery/Courier (for heading of this document, into the
section for registration date and written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
information. Management Staff (HFA–305), Food and and/or go to the Dockets Management
ADDRESSES: The public workshop will Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
be held at FDA White Oak Campus, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
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![Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices 60203
methods for demonstrating OINDP DEPARTMENT OF HEALTH AND research or marketing permits. Such
therapeutic equivalence. HUMAN SERVICES applications contain, among other
Registration: Persons interested in important items, full reports of all
Food and Drug Administration studies done to demonstrate product
attending this public workshop must
[Docket No. FDA–2011–N–0075] safety in man and/or other animals. In
register online by December 30, 2017, by
order to ensure adequate quality control
going to https://www.fda.gov/Drugs/
Agency Information Collection for these studies and to provide an
NewsEvents/ucm576064.htm. Please adequate degree of consumer protection,
provide complete contact information Activities; Submission for Office of
Management and Budget Review; the Agency issued good laboratory
for each attendee, including name, title, practice (GLP) regulations for
Comment Request; Good Laboratory
affiliation, address, email, and nonclinical laboratory studies in part 58
Practice Regulations for Nonclinical
telephone. The workshop agenda and (21 CFR part 58). The regulations
Studies
other background materials will be specify minimum standards for the
available approximately 2 weeks before AGENCY: Food and Drug Administration, proper conduct of safety testing and
the workshop at https://www.fda.gov/ HHS. contain sections on facilities, personnel,
Drugs/NewsEvents/ucm576064.htm. ACTION: Notice. equipment, standard operating
The agenda will include time for procedures (SOPs), test and control
questions and answers throughout the SUMMARY: The Food and Drug articles, quality assurance, protocol and
day and for general comments and Administration (FDA) is announcing conduct of a safety study, records and
questions from the audience following that a proposed collection of reports, and laboratory disqualification.
panel discussions. information has been submitted to the Part 58 requires testing facilities
Office of Management and Budget engaged in conducting toxicological
Registration is free and based on (OMB) for review and clearance under studies to retain, and make available to
space availability, with priority given to the Paperwork Reduction Act of 1995. regulatory officials, records regarding
early registrants. Persons interested in DATES: Fax written comments on the compliance with GLPs. Records are
attending this public workshop must collection of information by January 18, maintained on file at each testing
register by December 30, 2017, midnight 2018. facility and examined there periodically
Eastern Time. Early registration is by FDA inspectors. The GLP regulations
ADDRESSES: To ensure that comments on
recommended because seating is the information collection are received, require that, for each nonclinical
limited; therefore, FDA may limit the OMB recommends that written laboratory study, a final report be
number of participants from each comments be faxed to the Office of prepared that documents the results of
organization. If time and space permit, Information and Regulatory Affairs, quality assurance unit inspections, test
onsite registration on the day of the OMB, Attn: FDA Desk Officer, Fax: 202– and control article characterization,
public workshop will be provided 395–7285, or emailed to oira_ testing of mixtures of test and control
beginning at 8:30 a.m. submission@omb.eop.gov. All articles with carriers, and an overall
comments should be identified with the interpretation of nonclinical laboratory
If you need special accommodations studies. The GLP regulations also
due to a disability, please contact OMB control number 0910–0119. Also
require written records pertaining to: (1)
Renishkumar Delvadia no later than include the FDA docket number found
Personnel job descriptions and
December 30, 2017. in brackets in the heading of this
summaries of training and experience;
document.
Streaming Webcast of the public (2) master schedules, protocols and
workshop: This public workshop will FOR FURTHER INFORMATION CONTACT: Ila amendments thereto, inspection reports,
also be webcast. A live webcast of this S. Mizrachi, Office of Operations, Food and SOPs; (3) equipment inspection,
workshop will be viewable at https:// and Drug Administration, Three White maintenance, calibration, and testing
collaboration.fda.gov/r19djs3yfsf/ on Flint North, 10A–12M, 11601 records; (4) documentation of feed and
the day of the workshop. A video record Landsdown St., North Bethesda, MD water analyses, and animal treatments;
of the workshop will be available at the 20852, 301–796–7726, PRAStaff@ (5) test article accountability records;
fda.hhs.gov. and (6) study documentation and raw
same web address for 1 year. If you have
SUPPLEMENTARY INFORMATION: In data.
never attended a Connect Pro event Recordkeeping is necessary to
before, test your connection at https:// compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed document the conduct of nonclinical
collaboration.fda.gov/common/help/en/ laboratory studies of FDA-regulated
support/meeting_test.htm. To get a collection of information to OMB for
products to ensure the quality and
quick overview of the Connect Pro review and clearance.
integrity of the resulting final study
program, visit https://www.adobe.com/ Good Laboratory Practice Regulations report on which a regulatory decision
go/connectpro_overview. FDA has for Nonclinical Studies—21 CFR Part may be based. Written SOPs and records
verified the website addresses in this 58 of actions taken are essential for testing
document, as of the date this document facilities to implement GLPs effectively.
OMB Control Number 0910–0119—
publishes in the Federal Register, but Further, they are essential for FDA to be
Extension
websites are subject to change over time. able to determine a testing facility’s
Sections 409, 505, 512, and 515 of the compliance with the GLP regulations in
Dated: December 13, 2017.
Federal Food, Drug, and Cosmetic Act
sradovich on DSK3GMQ082PROD with NOTICES
part 58.
Leslie Kux, (21 U.S.C. 348, 355, 360b, and 360e) and In a notice of proposed rulemaking
Associate Commissioner for Policy. related statutes require manufacturers of published in the Federal Register of
[FR Doc. 2017–27279 Filed 12–18–17; 8:45 am] food additives, human drugs and August 24, 2016 (81 FR 58342), we
BILLING CODE 4164–01–P biological products, animal drugs, and proposed changes in our GLP
medical devices to demonstrate the regulations, including some of those
safety and utility of their product by listed in tables 1 and 2 of this
submitting applications to FDA for document. The document included
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Document Created: 2017-12-19 01:31:25
Document Modified: 2017-12-19 01:31:25
| 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 January 9, 2018, from 8:30 a.m. to 4:30 p.m. Individuals who wish to attend the workshop must register by December 30, 2017. Submit either electronic or written comments on this public workshop by February 14, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Renishkumar Delvadia, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4704, Silver Spring, MD 20993, 240-402- 7979, email: [email protected] | |
| FR Citation | 82 FR 60201 |
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