81_FR_80887 81 FR 80666 - Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry

81 FR 80666 - 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 81, Issue 221 (November 16, 2016)

Page Range80666-80667
FR Document2016-27454

The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2017 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.

Federal Register, Volume 81 Issue 221 (Wednesday, November 16, 2016) 
[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80666-80667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3744]


Site Visit Training Program for Office of Pharmaceutical Quality 
Staff; Information Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food 
and Drug Administration (FDA) is announcing the 2017 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 January 17, 2017. 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: CDEROPQSiteVisits@fda.hhs.gov.

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 drug development and a 
drug's commercial life cycle, including the variety of drug 
manufacturing operations. To support this commitment, CDER has 
initiated various training and development programs, including the 2017 
OPQ Staff 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 of the 
challenges that impact a drug's development program and commercial life 
cycle. The goal of these visits is to provide OPQ staff exposure to the 
drug development and manufacturing processes in industry; therefore, a 
tour of pharmaceutical company facilities is an integral part of the 
program.

II. The Site Visit Program

    In this site visit program, groups of OPQ staff--who have 
experience in a variety of backgrounds, including science, statistics, 
manufacturing, engineering and testing--will observe operations of 
commercial manufacturing, pilot plants, 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 and manufacturing 
may be provided, which may allow the participating sites to benefit by 
having an opportunity to showcase their technologies and manufacturing 
processes.
    OPQ encourages companies engaging in the development and 
manufacturing of both drug substances and drug products to respond. 
However, please note that this site visit program is not intended to 
supplement or to replace a regulatory inspection, e.g., a preapproval 
inspection, pre-license inspection or a surveillance inspection. OPQ 
staff participating in this program will grow professionally by gaining 
a better understanding of current industry practices, processes, and 
procedures.
    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 of these areas but is not intended to be exhaustive or 
to limit industry response:

 Drug products and active pharmaceutical ingredients
[cir] Solutions, suspensions, emulsions, and semisolids
[cir] Sustained, modified, and immediate release formulations
[cir] Drug-device combination products, particularly inhalation, 
transdermal, iontophoretic, and implant formulations
[cir] Biotechnology products
 Design, development, manufacturing, and controls
[cir] Engineering controls for aseptic formulations
[cir] Unique delivery technologies

[[Page 80667]]

[cir] Hot melt extrusion processes
[cir] Soft-gel encapsulation processes
[cir] Lyophilization processes
[cir] Blow-Fill-Seal and isolators
[cir] Spray-drying processes
[cir] Process analytical technology 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 regulatory 
status with FDA, and on 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 the DATES and FOR FURTHER INFORMATION 
CONTACT sections of this document for more information). To aid in 
OPQ's site selection, your proposal should include the following 
information:

 A contact person
 Site visit location(s)
 Facility Establishment Identifier and DUNS numbers, as 
applicable
 Maximum number of OPQ staff that can be accommodated during a 
site visit, and
 A sample agenda outlining the proposed learning objectives and 
associated activities for the site 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: November 9, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-27454 Filed 11-15-16; 8:45 am]
 BILLING CODE 4164-01-P

80666 Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices Fax Number: (202) 395–5806 OR Public: Individuals and Households; Program. This site visit program is Email: OIRA_submission@ Number of Respondents: 3,500; Total designed to offer experiential and omb.eop.gov Annual Responses: 3,500; Total Annual firsthand learning opportunities that To obtain copies of a supporting Hours: 583. (For policy questions will provide OPQ staff with a better statement and any related forms for the regarding this collection contact understanding of the pharmaceutical proposed collection(s) summarized in Winsome Higgins at 410–786–1835.) industry and its operations, as well as this notice, you may make your request Dated: November 9, 2016 of the challenges that impact a drug’s using one of following: development program and commercial William N. Parham, III, 1. Access CMS’ Web site address at life cycle. The goal of these visits is to http://www.cms.hhs.gov/ Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory provide OPQ staff exposure to the drug PaperworkReductionActof1995. Affairs. development and manufacturing 2. Email your request, including your processes in industry; therefore, a tour [FR Doc. 2016–27455 Filed 11–15–16; 8:45 am] address, phone number, OMB number, of pharmaceutical company facilities is BILLING CODE 4120–01–P and CMS document identifier, to an integral part of the program. Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at II. The Site Visit Program (410) 786–1326. DEPARTMENT OF HEALTH AND In this site visit program, groups of HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: OPQ staff—who have experience in a Reports Clearance Office at (410) 786– Food and Drug Administration variety of backgrounds, including 1326. science, statistics, manufacturing, [Docket No. FDA–2016–N–3744] engineering and testing—will observe SUPPLEMENTARY INFORMATION: Under the operations of commercial Paperwork Reduction Act of 1995 (PRA) Site Visit Training Program for Office manufacturing, pilot plants, and testing (44 U.S.C. 3501–3520), federal agencies of Pharmaceutical Quality Staff; over a 1- to 2-day period. To facilitate must obtain approval from the Office of Information Available to Industry the learning process for OPQ staff, Management and Budget (OMB) for each AGENCY: Food and Drug Administration, overview presentations by industry collection of information they conduct HHS. related to drug development and or sponsor. The term ‘‘collection of ACTION: Notice. manufacturing may be provided, which information’’ is defined in 44 U.S.C. may allow the participating sites to 3502(3) and 5 CFR 1320.3(c) and SUMMARY: The Center for Drug benefit by having an opportunity to includes agency requests or Evaluation and Research (CDER) in the showcase their technologies and requirements that members of the public Food and Drug Administration (FDA) is manufacturing processes. submit reports, keep records, or provide announcing the 2017 CDER Office of OPQ encourages companies engaging information to a third party. Section Pharmaceutical Quality (OPQ) Staff in the development and manufacturing 3506(c)(2)(A) of the PRA (44 U.S.C. Experiential Learning Site Visit of both drug substances and drug 3506(c)(2)(A)) requires federal agencies Program. The purpose of this document products to respond. However, please to publish a 30-day notice in the is to invite pharmaceutical companies note that this site visit program is not Federal Register concerning each interested in participating in this intended to supplement or to replace a proposed collection of information, program to submit a site visit proposal regulatory inspection, e.g., a including each proposed extension or to CDER’s OPQ. preapproval inspection, pre-license reinstatement of an existing collection DATES: Submit either an electronic or inspection or a surveillance inspection. of information, before submitting the written proposal to participate in this OPQ staff participating in this program collection to OMB for approval. To program by January 17, 2017. See will grow professionally by gaining a comply with this requirement, CMS is section IV of this document for better understanding of current industry publishing this notice that summarizes information on what to include in such practices, processes, and procedures. the following proposed collection(s) of Although observation of all aspects of information for public comment: proposals. drug development and production 1. Type of Information Collection FOR FURTHER INFORMATION CONTACT: would be beneficial to OPQ staff, OPQ Request: Extension of a currently Janet Wilson, Center for Drug Evaluation has identified a number of areas of approved collection; Title of and Research, Food and Drug particular interest to its staff. The Information Collection: Medicare Administration, 10903 New Hampshire following list identifies some of these Quality of Care Complaint Form; Use: In Ave., Bldg. 75, Rm. 4642, Silver Spring, areas but is not intended to be accordance with Section 1154(a)(14) of MD 20993–0002, 240–402–3969, email: exhaustive or to limit industry response: the Social Security Act, Quality CDEROPQSiteVisits@fda.hhs.gov. Improvement Organizations (QIOs) are • Drug products and active SUPPLEMENTARY INFORMATION: required to conduct appropriate reviews pharmaceutical ingredients I. Background Æ Solutions, suspensions, emulsions, of all written complaints submitted by and semisolids beneficiaries concerning the quality of A critical part of the commitment by Æ Sustained, modified, and immediate care received. The Medicare Quality of CDER to make safe and effective high- release formulations Care Complaint Form will be used by quality drugs available to the American Æ Drug-device combination products, Medicare beneficiaries to submit quality public is gaining an understanding of all asabaliauskas on DSK3SPTVN1PROD with NOTICES particularly inhalation, transdermal, of care complaints. This form will aspects of drug development and a iontophoretic, and implant establish a standard form for all drug’s commercial life cycle, including formulations beneficiaries to utilize and ensure the variety of drug manufacturing Æ Biotechnology products pertinent information is obtained by operations. To support this • Design, development, manufacturing, QIOs to effectively process these commitment, CDER has initiated and controls complaints. Form Number: CMS–10287 various training and development Æ Engineering controls for aseptic (OMB control number: 0938–1102); programs, including the 2017 OPQ Staff formulations Frequency: Occasionally; Affected Experiential Learning Site Visit Æ Unique delivery technologies VerDate Sep<11>2014 16:23 Nov 15, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1

Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices 80667 Æ Hot melt extrusion processes DEPARTMENT OF HEALTH AND Scholarship Program for Individuals from HUMAN SERVICES Disadvantaged Backgrounds, National Æ Soft-gel encapsulation processes Institutes of Health, HHS) Æ Lyophilization processes National Institutes of Health Dated: November 9, 2016. Æ Blow-Fill-Seal and isolators Anna Snouffer Office of the Director, National Deputy Director, Office of Federal Advisory Æ Spray-drying processes Institutes of Health; Notice of Meeting Committee Policy. Æ Process analytical technology and Real Time Release Testing Pursuant to section 10(a) of the [FR Doc. 2016–27463 Filed 11–15–16; 8:45 am] Federal Advisory Committee Act, as BILLING CODE 4140–01–P • Emerging technologies amended (5 U.S.C. App.), notice is Æ Continuous manufacturing hereby given of a meeting of the Advisory Committee to the Director, DEPARTMENT OF HEALTH AND Æ 3-dimensional printing National Institutes of Health. HUMAN SERVICES Æ Nanotechnology The meeting will be open to the public, with attendance limited to space National Institutes of Health III. Site Selection available. Individuals who plan to Center for Scientific Review; Notice of Selection of potential facilities will be attend and need special assistance, such Closed Meetings based on the priorities developed for as sign language interpretation or other OPQ staff training, the facility’s current reasonable accommodations, should Pursuant to section 10(d) of the regulatory status with FDA, and on notify the Contact Person listed below Federal Advisory Committee Act, as consultation with the appropriate FDA in advance of the meeting. amended (5 U.S.C. App.), notice is district office. All travel expenses Name of Committee: Advisory Committee hereby given of the following meetings. associated with this program will be the to the Director, National Institutes of Health. The meetings will be closed to the responsibility of OPQ; therefore, Date: December 8, 2016. public in accordance with the selection will be based on the Time: 9:00 a.m. to 5:15 p.m. provisions set forth in sections Agenda: NIH Director’s Report, ACD 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., availability of funds and resources for Working Group Reports. as amended. The grant applications and the fiscal year. OPQ will not provide Place: National Institutes of Health, financial compensation to the the discussions could disclose Building 31, 6th Floor Conference Room 6C, pharmaceutical site as part of this 31 Center Drive, Bethesda, MD 20892. confidential trade secrets or commercial program. property such as patentable material, Date: December 9, 2016. Time: 9:00 a.m. to 12:00 p.m. and personal information concerning IV. Proposals for Participation Agenda: Other business of the Committee. individuals associated with the grant Place: National Institutes of Health, applications, the disclosure of which Companies interested in offering a site Building 31, 6th Floor Conference Room 6C, would constitute a clearly unwarranted visit or learning more about this site 31 Center Drive, Bethesda, MD 20892. invasion of personal privacy. visit program should respond by Contact Person: Gretchen Wood, Staff Name of Committee: Center for Scientific submitting a proposal directly to Janet Assistant, National Institutes of Health, Review Special Emphasis Panel; Member Wilson (see the DATES and FOR FURTHER Office of the Director, One Center Drive, Conflict: Cardiovascular Sciences. INFORMATION CONTACT sections of this Building 1, Room 126, Bethesda, MD 20892, Date: November 30–December 1, 2016. document for more information). To aid 301–496–4272, Woodgs@od.nih.gov. Time: 12:00 p.m. to 4:00 p.m. Any interested person may file written in OPQ’s site selection, your proposal Agenda: To review and evaluate grant comments with the committee by forwarding should include the following applications. the statement to the Contact Person listed on information: Place: National Institutes of Health, 6701 this notice. The statement should include the Rockledge Drive, Bethesda, MD 20892, name, address, telephone number and when • A contact person (Virtual Meeting). applicable, the business or professional • Site visit location(s) Contact Person: Chee Lim, Ph.D., Center affiliation of the interested person. for Scientific Review, National Institutes of • Facility Establishment Identifier and In the interest of security, NIH has Health, 6701 Rockledge Drive, Room 4128, instituted stringent procedures for entrance DUNS numbers, as applicable onto the NIH campus. All visitor vehicles, Bethesda, MD 20892, 301–435–1850, limc4@ csr.nih.gov. • Maximum number of OPQ staff that including taxicabs, hotel and airport shuttles can be accommodated during a site will be inspected before being allowed on Name of Committee: Center for Scientific campus. Visitors will be asked to show one Review Special Emphasis Panel; Member visit, and Conflict: Cardiovascular and Respiratory form of identification (for example, a • A sample agenda outlining the government-issued photo ID, driver’s license, Special Emphasis Panel. proposed learning objectives and or passport) and to state the purpose of their Date: December 7, 2016. associated activities for the site visit visit. Time: 11:00 a.m. to 1:00 p.m. Information is also available on the Office Agenda: To review and evaluate grant Proposals submitted without this of the Director, National Institutes of Health, applications. minimum information will not be home page: http://acd.od.nih.gov, where an Place: National Institutes of Health, 6701 considered. Based on response rate and agenda and any additional information for Rockledge Drive, Bethesda, MD 20892, type of responses, OPQ may or may not the meeting will be posted when available. (Telephone Conference Call). consider alternative pathways to (Catalogue of Federal Domestic Assistance Contact Person: Olga A Tjurmina, Ph.D., asabaliauskas on DSK3SPTVN1PROD with NOTICES Program Nos. 93.14, Intramural Research Scientific Review Officer, Center for meeting our training goals. Scientific Review, National Institutes of Training Award; 93.22, Clinical Research Dated: November 9, 2016. Loan Repayment Program for Individuals Health, 6701 Rockledge Drive, Room 4138, Peter Lurie, from Disadvantaged Backgrounds; 93.232, MSC 7814, Bethesda, MD 20892, (301) 451– Loan Repayment Program for Research 1375, ot3d@nih.gov. Associate Commissioner for Public Health Generally; 93.39, Academic Research Name of Committee: Center for Scientific Strategy and Analysis. Enhancement Award; 93.936, NIH Acquired Review Special Emphasis Panel; Member [FR Doc. 2016–27454 Filed 11–15–16; 8:45 am] Immunodeficiency Syndrome Research Loan Conflict: Respiratory Sciences. BILLING CODE 4164–01–P Repayment Program; 93.187, Undergraduate Date: December 7–8, 2016. VerDate Sep<11>2014 16:23 Nov 15, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1


Document Created: 2016-11-16 00:57:19
Document Modified: 2016-11-16 00:57:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either an electronic or written proposal to participate in this program by January 17, 2017. See section IV of this document for information on what to include in such proposals.
ContactJanet 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 Citation81 FR 80666 
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