83 FR 42506 - Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 163 (August 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42506-42507 | |
| FR Document | 2018-18080 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42506-42507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18080] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2608] Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled ``Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/ CMC).'' This public meeting is intended to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the 2017 Federal Register notice (FRN), ``Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies.'' FDA will use the information from the public meeting to improve the usability of the proposed data standards. DATES: The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. 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. 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 16, 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. Docket comments previously submitted to the FRN (Docket No. FDA-2017-N-2166, https://www.federalregister.gov/a/2017-14456) noted in the SUMMARY section, should not be resubmitted, as these are already under consideration. 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-2018-N-2608 for ``Standardized Data for Pharmaceutical Quality/ Chemistry Manufacturing and Control; Public Meeting.'' 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 [[Page 42507]] ``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: Bryan Spells, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, [email protected], 240-402-6511; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Norman Gregory, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, [email protected], 240-402-0684; or Michael Kerrigan, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0644, [email protected]. Alternatively, send questions to the PQ- CMC mailbox: [email protected]. SUPPLEMENTARY INFORMATION: I. Background PQ/CMC is a term used to describe manufacturing and quality control information submitted to FDA in support of submissions. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. This information is primarily submitted in Module 3 of the Electronic Common Technical Document. The standardization of PQ/CMC data elements and terminologies will facilitate the Agency's transition to a streamlined electronic review environment. FDA intends to identify and standardize data elements and terminologies for information commonly used and submitted in support of drug product applications. The impetus for this standardization effort was the provisions from the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 301 note) (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a consistent look and feel for every application, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating standardized data dictionaries. As part of this effort, in 2017, FDA released a FRN presenting a ``Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies'' for public comment (https://www.federalregister.gov/a/2017-14456). FDA has subsequently utilized the comments received to revise and improve the data elements, terminologies, and definitions for PQ/CMC standardization. FDA intends to continue public engagement regarding PQ/CMC data standards development by holding the public meeting announced in this notice. After the public meeting, the Agency intends to issue a draft guidance on the standardization of PQ/CMC data elements and terminologies for electronic submissions. II. Purpose of the Public Meeting The purpose of the October 19, 2018, public meeting is to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the FRN, ``Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies,'' released in 2017 for public comment (https://www.federalregister.gov/a/2017-14456). FDA will use the information from the public meeting to improve the usability of the proposed data standards. The public meeting will focus on the current state of PQ/CMC standardization and its future development, to which the output and comments from this meeting will contribute. Topics of discussion may include: Ongoing development of PQ/CMC data elements and terminologies, including revisions informed by public response to the ``Draft Standardization'' FRN, developing the technical specifications for PQ/CMC data submissions, and upcoming development and testing of PQ/CMC data exchange mechanisms. Ongoing efforts to maximize harmonization of PQ/CMC standardization with other national and international data standardization activities sharing the same domain space as PQ/CMC (e.g., International Organization for Standardization Identification of Medicinal Products (ISO IDMP) standards development, the European Medicines Agency's Substance, Product, Organisation and Referential (SPOR) Master Data initiative). An understanding of industry business practices regarding submission of PQ/CMC data which will help to inform development of PQ/ CMC standardization. FDA will consider all comments made at this meeting or received through the docket (see ADDRESSES). III. Participating in the Public Meeting Registration: To register to attend ``Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting'' please register at: https://www.eventbrite.com/e/standardized-data-for-pqcmc-public-meeting-registration-47224509780 by September 21, 2018. 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 September 21, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Bryan Spells, 240-402-6511, email [email protected] at least 7 days before the meeting. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). Dated: August 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-18080 Filed 8-21-18; 8:45 am] BILLING CODE 4164-01-P
![42506 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
supplemental award is a key strategy for Register notice (FRN), ‘‘Draft as a manufacturing process. Please note
ORR to be prepared to meet its Standardization of Pharmaceutical that if you include your name, contact
responsibility to provide shelter for Quality/Chemistry Manufacturing and information, or other information that
Unaccompanied Children referred to its Control Data Elements and identifies you in the body of your
care by DHS and so that the U.S. Border Terminologies.’’ FDA will use the comments, that information will be
Patrol can continue its vital national information from the public meeting to posted on https://www.regulations.gov.
security mission to prevent illegal improve the usability of the proposed • If you want to submit a comment
migration, trafficking, and protect the data standards. with confidential information that you
borders of the United States. DATES: The public meeting will be held do not wish to be made available to the
Statutory Authority: This program is on October 19, 2018, from 9 a.m. to 4 public, submit the comment as a
authorized by— p.m. Submit either electronic or written written/paper submission and in the
(A) Section 462 of the Homeland comments on this public meeting by manner detailed (see ‘‘Written/Paper
Security Act of 2002, which in March November 16, 2018. Submissions’’ and ‘‘Instructions’’).
2003, transferred responsibility for the ADDRESSES: The public meeting will be Written/Paper Submissions
care and custody of Unaccompanied held at the FDA White Oak Campus,
Alien Children from the Commissioner Submit written/paper submissions as
10903 New Hampshire Ave., Bldg. 31 follows:
of the former Immigration and Conference Center, the Great Room (Rm. • Mail/Hand delivery/Courier (for
Naturalization Service (INS) to the 1503, Section A), Silver Spring, MD written/paper submissions): Dockets
Director of ORR of the Department of 20993–0002. Entrance for the public Management Staff (HFA–305), Food and
Health and Human Services (HHS). meeting participants (non-FDA Drug Administration, 5630 Fishers
(B) The Flores Settlement Agreement, employees) is through Building 1, where Lane, Rm. 1061, Rockville, MD 20852.
Case No. CV85–4544RJK (C. D. Cal. routine security check procedures will • For written/paper comments
1996), as well as the William be performed. For parking and security submitted to the Dockets Management
Wilberforce Trafficking Victims information, please refer to https:// Staff, FDA will post your comment, as
Protection Reauthorization Act of 2008 www.fda.gov/AboutFDA/ well as any attachments, except for
(Pub. L. 110–457), which authorizes WorkingatFDA/BuildingsandFacilities/ information submitted, marked and
post release services under certain WhiteOakCampusInformation/ identified, as confidential, if submitted
conditions to eligible children. All ucm241740.htm. as detailed in ‘‘Instructions.’’
programs must comply with the Flores You may submit comments as Instructions: All submissions received
Settlement Agreement, Case No. CV85– follows. Please note that late, untimely must include the Docket No. FDA–
4544–RJK (C.D. Cal. 1996), pertinent filed comments will not be considered. 2018–N–2608 for ‘‘Standardized Data
regulations and ORR policies and Electronic comments must be submitted for Pharmaceutical Quality/Chemistry
procedures. on or before November 16, 2018. The Manufacturing and Control; Public
Elizabeth Leo, https://www.regulations.gov electronic Meeting.’’ Received comments, those
Grants Policy Specialist, Division of Grants filing system will accept comments filed in a timely manner (see
Policy, Office of Administration. until midnight Eastern Time at the end ADDRESSES), will be placed in the docket
[FR Doc. 2018–18152 Filed 8–21–18; 8:45 am] of November 16, 2018. Comments and, except for those submitted as
BILLING CODE 4184–45–P
received by mail/hand delivery/courier ‘‘Confidential Submissions,’’ publicly
(for written/paper submissions) will be viewable at https://www.regulations.gov
considered timely if they are or at the Dockets Management Staff
DEPARTMENT OF HEALTH AND postmarked or the delivery service between 9 a.m. and 4 p.m., Monday
HUMAN SERVICES acceptance receipt is on or before that through Friday.
date. Docket comments previously • Confidential Submissions—To
Food and Drug Administration submitted to the FRN (Docket No. FDA– submit a comment with confidential
2017–N–2166, https:// information that you do not wish to be
[Docket No. FDA–2018–N–2608] made publicly available, submit your
www.federalregister.gov/a/2017-14456)
noted in the SUMMARY section, should comments only as a written/paper
Standardized Data for Pharmaceutical
not be resubmitted, as these are already submission. You should submit two
Quality/Chemistry Manufacturing and
under consideration. copies total. One copy will include the
Control; Public Meeting
information you claim to be confidential
AGENCY: Food and Drug Administration, Electronic Submissions with a heading or cover note that states
HHS. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
ACTION: Notice of public meeting. following way: CONFIDENTIAL INFORMATION.’’ The
• Federal eRulemaking Portal: Agency will review this copy, including
SUMMARY: The Food and Drug https://www.regulations.gov. Follow the the claimed confidential information, in
Administration (FDA or the Agency) is instructions for submitting comments. its consideration of comments. The
announcing the following public Comments submitted electronically, second copy, which will have the
meeting entitled ‘‘Standardized Data for including attachments, to https:// claimed confidential information
Pharmaceutical Quality/Chemistry www.regulations.gov will be posted to redacted/blacked out, will be available
Manufacturing and Control (PQ/CMC).’’ the docket unchanged. Because your for public viewing and posted on
This public meeting is intended to comment will be made public, you are https://www.regulations.gov. Submit
amozie on DSK3GDR082PROD with NOTICES1
provide members of the pharmaceutical solely responsible for ensuring that your both copies to the Dockets Management
industry and other interested comment does not include any Staff. If you do not wish your name and
stakeholders an opportunity to discuss confidential information that you or a contact information to be made publicly
with FDA, and provide input on, topics third party may not wish to be posted, available, you can provide this
and issues related to standardized data such as medical information, your or information on the cover sheet and not
for electronic submission of PQ/CMC anyone else’s Social Security number, or in the body of your comments and you
data, as detailed in the 2017 Federal confidential business information, such must identify this information as
VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/83_FR_42669/page/1.svg)
![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42507
‘‘confidential.’’ Any information marked The impetus for this standardization development and testing of PQ/CMC
as ‘‘confidential’’ will not be disclosed effort was the provisions from the Food data exchange mechanisms.
except in accordance with 21 CFR 10.20 and Drug Administration Safety and • Ongoing efforts to maximize
and other applicable disclosure law. For Innovation Act (21 U.S.C. 301 note) harmonization of PQ/CMC
more information about FDA’s posting (Pub. L. 112–144), which authorized the standardization with other national and
of comments to public dockets, see 80 Agency to require certain submissions international data standardization
FR 56469, September 18, 2015, or access to be submitted in a specified electronic activities sharing the same domain
the information at: https://www.gpo.gov/ format. The development of a structured space as PQ/CMC (e.g., International
fdsys/pkg/FR-2015-09-18/pdf/2015- format for PQ/CMC data will enable Organization for Standardization
23389.pdf. consistency in the content and format of Identification of Medicinal Products
Docket: For access to the docket to PQ/CMC data submitted, thus providing (ISO IDMP) standards development, the
read background documents or the a consistent look and feel for every European Medicines Agency’s
electronic and written/paper comments application, and, in general, Substance, Product, Organisation and
received, go to https:// contributing to a more efficient and Referential (SPOR) Master Data
www.regulations.gov and insert the effective regulatory decision-making
initiative).
docket number, found in brackets in the process by creating standardized data
heading of this document, into the dictionaries. • An understanding of industry
‘‘Search’’ box and follow the prompts As part of this effort, in 2017, FDA business practices regarding submission
and/or go to the Dockets Management released a FRN presenting a ‘‘Draft of PQ/CMC data which will help to
Staff, 5630 Fishers Lane, Rm. 1061, Standardization of Pharmaceutical inform development of PQ/CMC
Rockville, MD 20852. Quality/Chemistry Manufacturing and standardization.
FOR FURTHER INFORMATION CONTACT:
Control Data Elements and FDA will consider all comments made
Terminologies’’ for public comment at this meeting or received through the
Bryan Spells, Center for Drug Evaluation
(https://www.federalregister.gov/a/2017- docket (see ADDRESSES).
and Research, Food and Drug
14456). FDA has subsequently utilized
Administration, 10903 New Hampshire III. Participating in the Public Meeting
the comments received to revise and
Ave., Bldg. 51, Rm. 1117, Silver Spring,
improve the data elements,
MD 20993–0002, Bryan.Spells@ Registration: To register to attend
terminologies, and definitions for PQ/
fda.hhs.gov, 240–402–6511; Stephen ‘‘Standardized Data for Pharmaceutical
CMC standardization. FDA intends to
Ripley, Center for Biologics Evaluation Quality/Chemistry Manufacturing and
continue public engagement regarding
and Research, Food and Drug Control; Public Meeting’’ please register
PQ/CMC data standards development by
Administration, Bldg. 71, Rm. 7301, at: https://www.eventbrite.com/e/
holding the public meeting announced
Silver Spring, MD 20993–0002, 240– in this notice. After the public meeting, standardized-data-for-pqcmc-public-
402–7911; Norman Gregory, Center for the Agency intends to issue a draft meeting-registration-47224509780 by
Veterinary Medicine, Food and Drug guidance on the standardization of PQ/ September 21, 2018. Please provide
Administration, 7500 Standish Pl. CMC data elements and terminologies complete contact information for each
(HFV–143), Rockville, MD 20855, for electronic submissions. attendee, including name, title,
Norman.Gregory@fda.hhs.gov, 240– affiliation, address, email, and
402–0684; or Michael Kerrigan, Center II. Purpose of the Public Meeting telephone.
for Veterinary Medicine, Food and Drug The purpose of the October 19, 2018, Registration is free and based on
Administration, 7500 Standish Pl. public meeting is to provide members of space availability, with priority given to
(HFV–143), Rockville, MD 20855, 240– the pharmaceutical industry and other early registrants. Persons interested in
402–0644, Michael.Kerrigan@ interested stakeholders an opportunity attending this public meeting must
fda.hhs.gov. Alternatively, send to discuss with FDA, and provide input register by September 21, 2018,
questions to the PQ–CMC mailbox: PQ- on, topics and issues related to midnight Eastern Time. Early
CMC@fda.hhs.gov. standardized data for electronic registration is recommended because
SUPPLEMENTARY INFORMATION: submission of PQ/CMC data, as detailed seating is limited; therefore, FDA may
in the FRN, ‘‘Draft Standardization of limit the number of participants from
I. Background Pharmaceutical Quality/Chemistry each organization. Registrants will
PQ/CMC is a term used to describe Manufacturing and Control Data receive confirmation when they have
manufacturing and quality control Elements and Terminologies,’’ released been accepted.
information submitted to FDA in in 2017 for public comment (https://
support of submissions. PQ/CMC plays www.federalregister.gov/a/2017-14456). If you need special accommodations
an integral part in the regulatory review FDA will use the information from the due to a disability, please contact Bryan
process and life cycle management of public meeting to improve the usability Spells, 240–402–6511, email
pharmaceutical products. This of the proposed data standards. The Bryan.Spells@fda.hhs.gov at least 7 days
information is primarily submitted in public meeting will focus on the current before the meeting.
Module 3 of the Electronic Common state of PQ/CMC standardization and its Transcripts: Please be advised that as
Technical Document. The future development, to which the soon as a transcript of the public
standardization of PQ/CMC data output and comments from this meeting meeting is available, it will be accessible
elements and terminologies will will contribute. Topics of discussion at https://www.regulations.gov. It may
facilitate the Agency’s transition to a may include: be viewed at the Dockets Management
amozie on DSK3GDR082PROD with NOTICES1
streamlined electronic review • Ongoing development of PQ/CMC Staff (see ADDRESSES).
environment. data elements and terminologies, Dated: August 16, 2018.
FDA intends to identify and including revisions informed by public
Leslie Kux,
standardize data elements and response to the ‘‘Draft Standardization’’
terminologies for information FRN, developing the technical Associate Commissioner for Policy.
commonly used and submitted in specifications for PQ/CMC data [FR Doc. 2018–18080 Filed 8–21–18; 8:45 am]
support of drug product applications. submissions, and upcoming BILLING CODE 4164–01–P
VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/83_FR_42669/page/2.svg)
Document Created: 2018-08-22 00:38:21
Document Modified: 2018-08-22 00:38:21
| 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. | |
| Dates | The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018. | |
| Contact | Bryan Spells, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, [email protected], 240-402-6511; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Norman Gregory, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, Norman.Greg[email protected], 240-402-0684; or Michael Kerrigan, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143), Rockville, MD 20855, 240-402-0644, [email protected] Alternatively, send questions to the PQ- CMC mailbox: [email protected] | |
| FR Citation | 83 FR 42506 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR