83 FR 42903 - Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 165 (August 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 165 (August 24, 2018)
| Page Range | 42903-42904 | |
| FR Document | 2018-18305 |
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)] [Notices] [Pages 42903-42904] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18305] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3030] Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ. DATES: Submit either an electronic or written proposal to participate in this program by November 23, 2018. See section IV of this document for information on what to include in such proposals. FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240- 402-3969, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background A critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of a drug's development and commercial life cycle, including the variety of drug manufacturing operations. To support this commitment, CDER has initiated various training and development programs including the FY2019 Experiential Learning Site Visit program. This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug's developmental program and commercial life cycle. The goal of these visits is to enhance OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities, including manufacturing and laboratory operations, is an integral part of the experience. II. The Site Visit Program In this site visit program, groups on average of 15 to 20 OPQ staff--who have experience in a variety of backgrounds, including science, medicine, statistics, manufacturing, engineering, testing, and project management--will observe operations of commercial manufacturing, pilot plants (if applicable), and testing over a 1- to 2-day period. To facilitate the learning process for OPQ staff, overview presentations by industry related to drug development, manufacturing and testing may be included. OPQ encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to respond. Please note that this site visit program is not intended to supplement or replace a regulatory inspection, e.g., a preapproval inspection, prelicense inspection, or a surveillance inspection. [[Page 42904]] OPQ staff participating in this program will benefit by gaining a better understanding of current industry practices, processes, and procedures. Participating sites will have an opportunity to showcase their technologies and their actual manufacturing and testing facilities. Although observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ has identified a number of areas of particular interest to its staff. The following list identifies some examples of these areas but is not intended to be exhaustive, mutually exclusive, or to limit industry response:Drug products [cir] Solutions, suspensions, emulsions, and semisolids [cir] Modified- and immediate-release formulations [cir] Drug-device combination products (e.g., inhalation products, transdermal systems, implants intended for drug delivery, and prefilled syringes) Active pharmaceutical ingredients manufactured by [cir] Chemical synthesis [cir] Fermentation [cir] Biotechnology Design, development, manufacturing and controls [cir] Engineering controls for aseptic processes [cir] Novel delivery technologies [cir] Hot melt extrusion [cir] Soft-gel encapsulation [cir] Lyophilization [cir] Blow-Fill-Seal and isolators [cir] Spray-drying [cir] Process analytical technology, measurement systems, and real-time release testing Emerging technologies [cir] Continuous manufacturing [cir] 3-dimensional printing [cir] Nanotechnology III. Site Selection Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility's current compliance status with FDA, and in consultation with the appropriate FDA district office. All travel expenses associated with this program will be the responsibility of OPQ; therefore, selection will be based on the availability of funds and resources for the fiscal year. OPQ will not provide financial compensation to the pharmaceutical site as part of this program. IV. Proposals for Participation Companies interested in offering a site visit or learning more about this site visit program should respond by submitting a proposal directly to Janet Wilson (see DATES and FOR FURTHER INFORMATION CONTACT sections of this document for more information). To aid in OPQ's site selection and planning, your proposal should include the information below: A contact person, Site visit location(s), Facility Establishment Identifier and Data Universal Numbering System numbers, as applicable, Maximum number of FDA staff that can be accommodated during a site visit (maximum of 20), A proposed agenda outlining the learning objectives and associated activities for the site visit, Maximum number of site visits (no more than 2) that your site would be willing to host by the close of the government fiscal year, September 30, 2019, and Proposed dates for each site visit (i.e. month and week). Please note that the requested proposed agenda will be reviewed to determine the educational benefit to OPQ in conducting the visit, and selected sites may be asked to refine the agenda to maximize the educational benefit. After a site is selected, OPQ will communicate with the contact person for the site to determine the actual dates for the visit. Proposals submitted without this minimum information will not be considered. Based on response rate and type of responses, OPQ may or may not consider alternative pathways to meeting our training goals. Dated: August 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-18305 Filed 8-23-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42903
heading of this document, into the alternative approach if it satisfies the program by November 23, 2018. See
‘‘Search’’ box and follow the prompts requirements of the applicable statutes section IV of this document for
and/or go to the Dockets Management and regulations. This guidance is not information on what to include in such
Staff, 5630 Fishers Lane, Rm. 1061, subject to Executive Order 12866. proposals.
Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
II. Paperwork Reduction Act of 1995
You may submit comments on any Janet Wilson, Center for Drug Evaluation
guidance at any time (see 21 CFR This draft guidance refers to and Research, Food and Drug
10.115(g)(5)). previously approved collections of Administration, 10903 New Hampshire
Submit written requests for single information found in FDA regulations. Ave., Bldg. 75, Rm. 4642, Silver Spring,
copies of the draft guidance to the These collections of information are MD 20993–0002, 240–402–3969, email:
Division of Drug Information, Center for subject to review by the Office of CDEROPQSiteVisits@fda.hhs.gov.
Drug Evaluation and Research, Food Management and Budget (OMB) under
SUPPLEMENTARY INFORMATION:
and Drug Administration, 10001 New the Paperwork Reduction Act of 1995
Hampshire Ave., Hillandale Building, (44 U.S.C. 3501–3520). The collection of I. Background
4th Floor, Silver Spring, MD 20993– information in 21 CFR part 312 A critical part of the commitment by
0002, or Office of Communication, (Investigational New Drug Application) CDER to make safe and effective high-
Outreach, and Development, Center for has been approved under OMB control quality drugs available to the American
Biologics Evaluation and Research, number 0910–0014. The collections of public is gaining an understanding of all
Food and Drug Administration, 10903 information in 21 CFR parts 50 and 56 aspects of a drug’s development and
New Hampshire Ave., Bldg. 71, Rm. (Protection of Human Subjects: commercial life cycle, including the
3128, Silver Spring, MD 20993–0002. Informed Consent; Institutional Review variety of drug manufacturing
Send one self-addressed adhesive label Boards) have been approved under OMB operations. To support this
to assist that office in processing your control number 0910–0755. commitment, CDER has initiated
requests. See the SUPPLEMENTARY III. Electronic Access various training and development
INFORMATION section for electronic programs including the FY2019
access to the draft guidance document. Persons with access to the internet
Experiential Learning Site Visit
FOR FURTHER INFORMATION CONTACT: Julia may obtain the draft guidance at either
program. This site visit program is
Beaver, Center for Drug Evaluation and https://www.fda.gov/Drugs/Guidance
designed to offer experiential and
Research, Food and Drug ComplianceRegulatoryInformation/
firsthand learning opportunities that
Administration, 10903 New Hampshire Guidances/default.htm, https://
will provide OPQ staff with a better
Ave., Bldg. 22, Rm. 2100, Silver Spring, www.fda.gov/BiologicsBloodVaccines/
understanding of the pharmaceutical
MD 20993–0002, 240–402–0489; or GuidanceComplianceRegulatory
industry and its operations, as well as
Stephen Ripley, Center for Biologics Information/Guidances/default.htm, or
the challenges that impact a drug’s
Evaluation and Research, Food and https://www.regulations.gov.
developmental program and commercial
Drug Administration, 10903 New Dated: August 21, 2018. life cycle. The goal of these visits is to
Hampshire Ave., Bldg. 71, Rm. 7301, Leslie Kux, enhance OPQ staff exposure to the drug
Silver Spring, MD 20993–0002, 240– Associate Commissioner for Policy. development and manufacturing
402–7911. [FR Doc. 2018–18339 Filed 8–23–18; 8:45 am] processes in industry; therefore, a tour
SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P of pharmaceutical company facilities,
including manufacturing and laboratory
I. Background
operations, is an integral part of the
FDA is announcing the availability of DEPARTMENT OF HEALTH AND experience.
a draft guidance for industry entitled HUMAN SERVICES
‘‘Hematologic Malignancy and II. The Site Visit Program
Oncologic Disease: Considerations for Food and Drug Administration In this site visit program, groups on
Use of Placebos and Blinding in average of 15 to 20 OPQ staff—who have
[Docket No. FDA–2018–N–3030]
Randomized Controlled Clinical Trials experience in a variety of backgrounds,
for Drug Product Development.’’ This Site Visit Training Program for Office including science, medicine, statistics,
draft guidance provides of Pharmaceutical Quality Staff; manufacturing, engineering, testing, and
recommendations to industry regarding Information Available to Industry project management—will observe
the use of placebos and blinding in operations of commercial
randomized controlled clinical trials in AGENCY: Food and Drug Administration, manufacturing, pilot plants (if
development programs for drug or HHS. applicable), and testing over a 1- to 2-
biological products for the treatment of ACTION: Notice. day period. To facilitate the learning
hematologic malignancies and oncologic process for OPQ staff, overview
diseases regulated by CDER and CBER. SUMMARY: The Center for Drug presentations by industry related to
This draft guidance is being issued Evaluation and Research (CDER) in the drug development, manufacturing and
consistent with FDA’s good guidance Food and Drug Administration (FDA) is testing may be included.
practices regulation (21 CFR 10.115). announcing the Fiscal Year 2019 CDER OPQ encourages companies engaging
The draft guidance, when finalized, will Office of Pharmaceutical Quality (OPQ) in the development and manufacturing
represent the current thinking of FDA Staff Experiential Learning Site Visit of both active pharmaceutical
daltland on DSKBBV9HB2PROD with NOTICES
on the use of placebos and blinding in Program. The purpose of this document ingredients (small and large molecules)
randomized controlled clinical trials for is to invite pharmaceutical companies and drug products to respond. Please
drug product development for interested in participating in this note that this site visit program is not
hematologic malignancy and oncologic program to submit a site visit proposal intended to supplement or replace a
disease. It does not establish any rights to CDER’s OPQ. regulatory inspection, e.g., a
for any person and is not binding on DATES: Submit either an electronic or preapproval inspection, prelicense
FDA or the public. You can use an written proposal to participate in this inspection, or a surveillance inspection.
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![42904 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
OPQ staff participating in this submitting a proposal directly to Janet applications meet certain criteria. The
program will benefit by gaining a better Wilson (see DATES and FOR FURTHER FD&C Act lists the diseases that are
understanding of current industry INFORMATION CONTACT sections of this considered tropical diseases for
practices, processes, and procedures. document for more information). To aid purposes of obtaining PRVs and
Participating sites will have an in OPQ’s site selection and planning, provides for Agency expansion of that
opportunity to showcase their your proposal should include the list to include other diseases that satisfy
technologies and their actual information below: the definition of ‘‘tropical diseases’’ as
manufacturing and testing facilities. • A contact person, set forth in the FD&C Act. The Agency
Although observation of all aspects of • Site visit location(s), has determined that chikungunya virus
drug development and production • Facility Establishment Identifier disease, Lassa fever, rabies, and
would be beneficial to OPQ staff, OPQ and Data Universal Numbering System cryptococcal meningitis satisfy this
has identified a number of areas of numbers, as applicable, definition and is therefore adding them
particular interest to its staff. The • Maximum number of FDA staff that to the list of designated tropical diseases
following list identifies some examples can be accommodated during a site visit whose product applications may result
of these areas but is not intended to be (maximum of 20), in the award of PRVs. Sponsors
exhaustive, mutually exclusive, or to • A proposed agenda outlining the submitting certain drug or biological
limit industry response: learning objectives and associated
product applications for the prevention
• Drug products activities for the site visit,
or treatment of chikungunya virus
Æ Solutions, suspensions, emulsions, • Maximum number of site visits (no
disease, Lassa fever, rabies, and
and semisolids more than 2) that your site would be
willing to host by the close of the cryptococcal meningitis may be eligible
Æ Modified- and immediate-release
formulations government fiscal year, September 30, to receive a PRV if such applications are
Æ Drug-device combination products 2019, and approved by FDA.
(e.g., inhalation products, transdermal • Proposed dates for each site visit DATES: This order is effective August 24,
systems, implants intended for drug (i.e. month and week). 2018.
delivery, and prefilled syringes) Please note that the requested
• Active pharmaceutical ingredients proposed agenda will be reviewed to ADDRESSES: Submit electronic
manufactured by determine the educational benefit to comments on additional diseases
Æ Chemical synthesis OPQ in conducting the visit, and suggested for designation to https://
Æ Fermentation selected sites may be asked to refine the www.regulations.gov. Submit written
Æ Biotechnology agenda to maximize the educational comments on additional diseases
• Design, development, manufacturing benefit. After a site is selected, OPQ will suggested for designation to the Dockets
and controls communicate with the contact person Management Staff (HFA–305), Food and
Æ Engineering controls for aseptic for the site to determine the actual dates Drug Administration, 5630 Fishers
processes for the visit. Lane, Rm. 1061, Rockville, MD 20852.
Æ Novel delivery technologies Proposals submitted without this All comments should be identified with
Æ Hot melt extrusion minimum information will not be the docket number found in brackets in
Æ Soft-gel encapsulation considered. Based on response rate and the heading of this document.
Æ Lyophilization type of responses, OPQ may or may not
Æ Blow-Fill-Seal and isolators FOR FURTHER INFORMATION CONTACT:
consider alternative pathways to
Æ Spray-drying meeting our training goals. Katherine Schumann, Center for Drug
Æ Process analytical technology, Evaluation and Research, Food and
measurement systems, and real-time Dated: August 21, 2018. Drug Administration, 10903 New
release testing Leslie Kux, Hampshire Ave., Bldg. 22, Rm. 6242,
• Emerging technologies Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301–
Æ Continuous manufacturing [FR Doc. 2018–18305 Filed 8–23–18; 8:45 am] 796–1300, Katherine.Schumann@
Æ 3-dimensional printing BILLING CODE 4164–01–P fda.hhs.gov; or Office of
Æ Nanotechnology Communication, Outreach and
III. Site Selection Development (OCOD), Center for
DEPARTMENT OF HEALTH AND Biologics Evaluation and Research,
Selection of potential facilities will be HUMAN SERVICES Food and Drug Administration, 10903
based on the priorities developed for New Hampshire Ave., Silver Spring, MD
OPQ staff training, the facility’s current Food and Drug Administration
20993–0002, 1–800–835–4709 or 240–
compliance status with FDA, and in
[Docket No. FDA–2008–N–0567] 402–8010, ocod@fda.hhs.gov.
consultation with the appropriate FDA
district office. All travel expenses Designating Additions to the Current SUPPLEMENTARY INFORMATION:
associated with this program will be the List of Tropical Diseases in the Federal
responsibility of OPQ; therefore, Table of Contents
Food, Drug, and Cosmetic Act
selection will be based on the I. Background: Priority Review Voucher
availability of funds and resources for AGENCY: Food and Drug Administration, Program
the fiscal year. OPQ will not provide HHS. II. Diseases Being Designated
financial compensation to the ACTION: Final order. A. Chikungunya Virus Disease
daltland on DSKBBV9HB2PROD with NOTICES
pharmaceutical site as part of this B. Lassa Fever
program. SUMMARY: The Federal Food, Drug, and C. Rabies
Cosmetic Act (FD&C Act) authorizes the D. Cryptococcal Meningitis
IV. Proposals for Participation Food and Drug Administration (FDA or III. Process for Requesting Additional
Companies interested in offering a site Agency) to award priority review Diseases To Be Added to the List
visit or learning more about this site vouchers (PRVs) to tropical disease IV. Paperwork Reduction Act
visit program should respond by product applicants when the V. References
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Document Created: 2018-08-24 04:13:48
Document Modified: 2018-08-24 04:13:48
| 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. | |
| Dates | Submit either an electronic or written proposal to participate in this program by November 23, 2018. See section IV of this document for information on what to include in such proposals. | |
| Contact | Janet Wilson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240- 402-3969, email: [email protected] | |
| FR Citation | 83 FR 42903 |
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