81_FR_15366 81 FR 15311 - 2016 Parenteral Drug Association/Food and Drug Administration Joint Conference: Aligning Manufacturing Goals With Patient Needs Through Successful Innovation and Compliance

81 FR 15311 - 2016 Parenteral Drug Association/Food and Drug Administration Joint Conference: Aligning Manufacturing Goals With Patient Needs Through Successful Innovation and Compliance

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 55 (March 22, 2016)

Page Range15311-15313
FR Document2016-06366

The Food and Drug Administration (FDA) is announcing a public conference, to be held in cosponsorship with the Parenteral Drug Association (PDA), entitled ``Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.'' The conference will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies, and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.

Federal Register, Volume 81 Issue 55 (Tuesday, March 22, 2016) 
[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15311-15313]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


2016 Parenteral Drug Association/Food and Drug Administration 
Joint Conference: Aligning Manufacturing Goals With Patient Needs 
Through Successful Innovation and Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
conference, to be held in cosponsorship with the Parenteral Drug 
Association (PDA), entitled ``Aligning Manufacturing Goals with Patient 
Needs through Successful Innovation and Compliance.'' The conference 
will cover current issues affecting the industry as well as explore 
strategies to facilitate the development and continuous improvement of 
safe and effective medical products. The conference establishes a 
unique forum to discuss the foundations, emerging technologies, and 
innovations in regulatory science, as well as the current quality and 
compliance areas of concerns. Meeting participants will hear from FDA 
and industry speakers about the requirements and best practices to 
consider while implementing robust quality systems in order to deliver 
the best quality product.

DATES: The public conference will be held on September 12, 2016, from 7 
a.m. to 7:30 p.m.; September 13, 2016, from

[[Page 15312]]

7 a.m. to 9:30 p.m.; and September 14, 2016, from 7 a.m. to 12:30 p.m.

ADDRESSES: The public conference will be held at the Renaissance 
Washington, DC Downtown Hotel, 999 Ninth Street NW., Washington, DC 
20001, 202-898-9000, FAX: 202-289-0947.

FOR FURTHER INFORMATION CONTACT: Wanda Neal, Parenteral Drug 
Association, PDA Global Headquarters, Bethesda Towers, 4350 East West 
Hwy., Suite 150, Bethesda, MD 20814, 301-656-5900, ext. 111, FAX: 301-
986-1093, email: [email protected]; or Ken Nolan, Office of Communications, 
Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, 
MD 20993, 301-796-8629, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The PDA/FDA Joint Regulatory Conference offers the unique 
opportunity for participants to join FDA representatives and industry 
experts in face-to-face dialogues. Each year, FDA speakers provide 
updates on current efforts affecting the development of global 
regulatory strategies, while industry professionals from pharmaceutical 
companies present case studies on how they employ global strategies in 
their daily processes.
    Through a series of sessions and meetings, the conference will 
provide participants with the opportunity to hear directly from FDA 
experts and representatives of global regulatory authorities on best 
practices, including:
     Product Quality
     Data Integrity
     Breakthrough Therapies
     Regulatory Challenges and Opportunities
     Lifecycle Management
     Clinically Relevant Specifications
     Food and Drug Administration Safety and Innovation Act
     Quality Metrics/Quality Culture
     Manufacturing of the Future With Submissions
     Continuous Verification and Validation
     Continuous Manufacturing
     ``Fishbowl'' Role Play
     Quality Systems
     Contract Manufacturing Organizations
     Maturity of Quality Systems
     Investigations
     Case Studies for Quality
     Quality Submissions
     Prescription Drug User Fee Act
     Risk-Based Control Strategies
     Supply Chain
     Quality Risk Management Systems
     Drug Shortages
     Customer Complaint Reviews and Trending
     Human Factors
     Office of Pharmaceutical Quality and Program Alignment 
Group
     Patient Perspective
     Compliance Update
     Center Initiatives--Regulatory Submission Update
    To help ensure the quality of FDA-regulated products, the workshop 
helps to achieve objectives set forth in section 406 of the FDA 
Modernization Act of 1997 (21 U.S.C. 393), which includes working 
closely with stakeholders and maximizing the availability and clarity 
of information to stakeholders and the public. The workshop also is 
consistent with the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Pub. L. 104-121), as outreach activities by government 
agencies to small businesses.

II. Registration and Accommodations

A. Registration

    Attendees are encouraged to register at their earliest convenience. 
The PDA registration fees cover the cost of facilities, materials, and 
refreshments. Seats are limited; please submit your registration as 
soon as possible. Conference space will be filled in order of receipt 
of registration. Those accepted for the conference will receive 
confirmation. Registration will close after the conference is filled. 
Onsite registration will be available on a space available basis 
beginning at 1 p.m. on September 11, 2016, and at 7 a.m. from September 
12 through 14, 2016. The cost of registration is as follows:

                                              Cost of Registration
----------------------------------------------------------------------------------------------------------------
                                                                    Before July   July 1- August   After August
                           Affiliation                                1, 2016        2,  2016         2, 2016
----------------------------------------------------------------------------------------------------------------
                         Premier Package (Includes Conference and Workshop Registration)
----------------------------------------------------------------------------------------------------------------
Member..........................................................          $3,740          $4,190          $4,640
Nonmember.......................................................           4,199           4,649           5,099
----------------------------------------------------------------------------------------------------------------
                                                 Conference Only
----------------------------------------------------------------------------------------------------------------
Member..........................................................           2,395           2,795           2,995
Nonmember.......................................................           2,654           3,054           3,254
Government/Health Authority Member..............................             700             700             700
Government/Health Authority Nonmember \1\.......................             800             800             800
Academic Member.................................................             700             700             700
Academic Nonmember \1\..........................................             800             800             800
Student Member..................................................             280             280             280
Student Nonmember \1\...........................................             310             310             310
----------------------------------------------------------------------------------------------------------------
\1\For this member type, online registration is not available and must be faxed in.

    Please visit PDA's Web site: www.pda.org/pdafda2016 to confirm the 
prevailing registration fees. (FDA has verified the Web site address, 
but FDA is not responsible for any subsequent changes to the Web site 
after this document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please 
contact Wanda Neal (see FOR FURTHER INFORMATION CONTACT), at least 7 
days in advance of the conference.
    Registration Instructions: To register, please submit your name, 
affiliation, mailing address, telephone, fax number, and email address, 
along with a check or money order payable to ``PDA.'' Mail to: PDA, 
Global Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 150, 
Bethesda, MD 20814. To register via the Internet, go to PDA's Web site: 
www.pda.org/pdafda2016.

[[Page 15313]]

    The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting, 
or for questions on registration, contact PDA (see FOR FURTHER 
INFORMATION CONTACT).

B. Accommodations

    Attendees are responsible for their own accommodations. To make 
reservations, contact the Renaissance Washington Hotel (see ADDRESSES) 
and reference ``the 2016 PDA/FDA Joint Regulatory Conference'' to 
receive the PDA group rate. Room rates are: Single: $305 plus 14.5 
percent State and local taxes. Requests will be processed on a first-
come, first-served basis.
    Transcripts: As soon as a transcript is available, it can be 
obtained in either hardcopy or on CD-ROM, after submission of a Freedom 
of Information request. The Freedom of Information office address is 
available on the Agency's Web site at http://www.fda.gov.

    Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06366 Filed 3-21-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices 15311 regulatoryinformation/dockets/ testing of RF-induced heating in the MR OMB control number 0910–0332; the default.htm. environment. Additionally, this collections of information in 21 CFR Docket: For access to the docket to guidance provides recommendations on part 807, subpart E, are approved under read background documents or the how to assess the RF-induced device OMB control number 0910–0120; the electronic and written/paper comments heating for multiconfiguration passive collections of information in 21 CFR received, go to http:// medical devices. part 812 are approved under OMB www.regulations.gov and insert the In the Federal Register of June 29, control number 0910–0078; the docket number, found in brackets in the 2015 (80 FR 36996), the Agency collections of information in 21 CFR heading of this document, into the announced the issuance of the draft parts 801 and 809 are approved under ‘‘Search’’ box and follow the prompts guidance entitled ‘‘Assessment of OMB control number 0910–0485; and and/or go to the Division of Dockets Radiofrequency-Induced Heating in the the collections of information in the Management, 5630 Fishers Lane, Rm. Magnetic Resonance (MR) Environment guidance document entitled ‘‘Requests 1061, Rockville, MD 20852. for Multi-Configuration Passive Medical for Feedback on Medical Device An electronic copy of the guidance Devices.’’ Interested persons were Submissions: The Pre-Submission document is available for download invited to comment by August 28, 2015. Program and Meetings with Food and from the Internet. See the II. Significance of Guidance Drug Administration Staff’’ are SUPPLEMENTARY INFORMATION section for approved under OMB control number information on electronic access to the This guidance is being issued 0910–0756. guidance. Submit written requests for a consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Dated: March 16, 2016. single hard copy of the guidance Leslie Kux, document entitled ‘‘Assessment of The guidance represents the current thinking of FDA on the assessment of Associate Commissioner for Policy. Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment RF-induced heating of multicomponent, [FR Doc. 2016–06361 Filed 3–21–16; 8:45 am] for Multi-Configuration Passive Medical or multiconfiguration, passive medical BILLING CODE 4164–01–P Devices’’ to the Office of the Center devices in the MR environment. It does Director, Guidance and Policy not establish any rights for any person Development, Center for Devices and and is not binding on FDA or the public. DEPARTMENT OF HEALTH AND Radiological Health, Food and Drug You can use an alternative approach if HUMAN SERVICES Administration, 10903 New Hampshire it satisfies the requirements of the applicable statutes and regulations. Food and Drug Administration Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self- III. Electronic Access [Docket No. FDA–2016–N–0001] addressed adhesive label to assist that Persons interested in obtaining a copy office in processing your request. 2016 Parenteral Drug Association/Food of the guidance may do so by and Drug Administration Joint FOR FURTHER INFORMATION CONTACT: downloading an electronic copy from Conference: Aligning Manufacturing Wolfgang Kainz, Center for Devices and the Internet. A search capability for all Goals With Patient Needs Through Radiological Health, Food and Drug Center for Devices and Radiological Successful Innovation and Compliance Administration, 10903 New Hampshire Health guidance documents is available Ave., Bldg. 62, Rm. 1115, Silver Spring, at http://www.fda.gov/MedicalDevices/ AGENCY: Food and Drug Administration, MD 20993–0002, 301–661–7595. DeviceRegulationandGuidance/ HHS. SUPPLEMENTARY INFORMATION: GuidanceDocuments/default.htm. ACTION: Notice of public conference. I. Background Guidance documents are also available at http://www.regulations.gov. Persons SUMMARY: The Food and Drug FDA is announcing the availability of unable to download an electronic copy Administration (FDA) is announcing a a guidance to provide an assessment of ‘‘Assessment of Radiofrequency- public conference, to be held in paradigm for RF-induced heating on or Induced Heating in the Magnetic cosponsorship with the Parenteral Drug near multicomponent or Resonance (MR) Environment for Multi- Association (PDA), entitled ‘‘Aligning multiconfiguration passive medical Configuration Passive Medical Devices’’ Manufacturing Goals with Patient Needs devices in the MR environment. During may send an email request to CDRH- through Successful Innovation and MR scanning, applied RF excitation Guidance@fda.hhs.gov to receive an Compliance.’’ The conference will cover pulses induce currents that can cause electronic copy of the document. Please current issues affecting the industry as heating of electrically conductive use the document number 1500001 to well as explore strategies to facilitate the materials. RF-induced heating of identify the guidance you are development and continuous medical devices made with conductive requesting. improvement of safe and effective materials may lead to patient burns. To medical products. The conference minimize the risk of patient burns IV. Paperwork Reduction Act of 1995 establishes a unique forum to discuss during MR scanning, sponsors should This draft guidance refers to the foundations, emerging technologies, comprehensively assess devices in all previously approved collections of and innovations in regulatory science, configurations and combinations. information found in FDA regulations as well as the current quality and However, multicomponent passive and guidance. These collections of compliance areas of concerns. Meeting devices, such as orthopedic fixation information are subject to review by the participants will hear from FDA and asabaliauskas on DSK3SPTVN1PROD with NOTICES devices, may permit a very large number Office of Management and Budget industry speakers about the of possible device configurations and (OMB) under the Paperwork Reduction requirements and best practices to combinations of individual components. Act of 1995 (44 U.S.C. 3501–3520). The consider while implementing robust Testing all possibilities may be collections of information in 21 CFR quality systems in order to deliver the impractical and unnecessary. This part 814, subparts B and E, are approved best quality product. guidance provides an approach to under OMB control number 0910–0231; DATES: The public conference will be identify a manageable number of device the collections of information in 21 CFR held on September 12, 2016, from 7 a.m. configurations or combinations for the part 814, subpart H, are approved under to 7:30 p.m.; September 13, 2016, from VerDate Sep<11>2014 17:34 Mar 21, 2016 Jkt 238001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1

15312 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices 7 a.m. to 9:30 p.m.; and September 14, hear directly from FDA experts and • Compliance Update 2016, from 7 a.m. to 12:30 p.m. representatives of global regulatory • Center Initiatives—Regulatory ADDRESSES: The public conference will authorities on best practices, including: Submission Update be held at the Renaissance Washington, • Product Quality To help ensure the quality of FDA- DC Downtown Hotel, 999 Ninth Street • Data Integrity regulated products, the workshop helps NW., Washington, DC 20001, 202–898– • Breakthrough Therapies to achieve objectives set forth in section 9000, FAX: 202–289–0947. • Regulatory Challenges and 406 of the FDA Modernization Act of FOR FURTHER INFORMATION CONTACT: Opportunities 1997 (21 U.S.C. 393), which includes Wanda Neal, Parenteral Drug • Lifecycle Management working closely with stakeholders and Association, PDA Global Headquarters, • Clinically Relevant Specifications maximizing the availability and clarity Bethesda Towers, 4350 East West Hwy., • Food and Drug Administration of information to stakeholders and the Suite 150, Bethesda, MD 20814, 301– Safety and Innovation Act public. The workshop also is consistent 656–5900, ext. 111, FAX: 301–986– • Quality Metrics/Quality Culture with the Small Business Regulatory 1093, email: info@pda.org; or Ken • Manufacturing of the Future With Enforcement Fairness Act of 1996 (Pub. Nolan, Office of Communications, Food Submissions L. 104–121), as outreach activities by and Drug Administration 10903 New • Continuous Verification and government agencies to small Hampshire Ave., Silver Spring, MD Validation businesses. 20993, 301–796–8629, email: • Continuous Manufacturing kenneth.nolan@fda.hhs.gov. • ‘‘Fishbowl’’ Role Play II. Registration and Accommodations SUPPLEMENTARY INFORMATION: • Quality Systems A. Registration • Contract Manufacturing I. Background Organizations Attendees are encouraged to register The PDA/FDA Joint Regulatory • Maturity of Quality Systems at their earliest convenience. The PDA Conference offers the unique • Investigations registration fees cover the cost of opportunity for participants to join FDA • Case Studies for Quality facilities, materials, and refreshments. representatives and industry experts in • Quality Submissions Seats are limited; please submit your face-to-face dialogues. Each year, FDA • Prescription Drug User Fee Act registration as soon as possible. speakers provide updates on current • Risk-Based Control Strategies Conference space will be filled in order efforts affecting the development of • Supply Chain of receipt of registration. Those accepted global regulatory strategies, while • Quality Risk Management Systems for the conference will receive industry professionals from • Drug Shortages confirmation. Registration will close pharmaceutical companies present case • Customer Complaint Reviews and after the conference is filled. Onsite studies on how they employ global Trending registration will be available on a space strategies in their daily processes. • Human Factors available basis beginning at 1 p.m. on Through a series of sessions and • Office of Pharmaceutical Quality September 11, 2016, and at 7 a.m. from meetings, the conference will provide and Program Alignment Group September 12 through 14, 2016. The participants with the opportunity to • Patient Perspective cost of registration is as follows: COST OF REGISTRATION July 1– Before July After August Affiliation August 2, 1, 2016 2, 2016 2016 Premier Package (Includes Conference and Workshop Registration) Member ........................................................................................................................................ $3,740 $4,190 $4,640 Nonmember ................................................................................................................................. 4,199 4,649 5,099 Conference Only Member ........................................................................................................................................ 2,395 2,795 2,995 Nonmember ................................................................................................................................. 2,654 3,054 3,254 Government/Health Authority Member ........................................................................................ 700 700 700 Government/Health Authority Nonmember 1 ............................................................................... 800 800 800 Academic Member ....................................................................................................................... 700 700 700 Academic Nonmember 1 .............................................................................................................. 800 800 800 Student Member .......................................................................................................................... 280 280 280 Student Nonmember 1 ................................................................................................................. 310 310 310 1For this member type, online registration is not available and must be faxed in. asabaliauskas on DSK3SPTVN1PROD with NOTICES Please visit PDA’s Web site: If you need special accommodations and email address, along with a check www.pda.org/pdafda2016 to confirm due to a disability, please contact or money order payable to ‘‘PDA.’’ Mail the prevailing registration fees. (FDA Wanda Neal (see FOR FURTHER to: PDA, Global Headquarters, Bethesda has verified the Web site address, but INFORMATION CONTACT), at least 7 days in Towers, 4350 East West Hwy., Suite FDA is not responsible for any advance of the conference. 150, Bethesda, MD 20814. To register subsequent changes to the Web site after Registration Instructions: To register, via the Internet, go to PDA’s Web site: this document publishes in the Federal please submit your name, affiliation, www.pda.org/pdafda2016. Register.) mailing address, telephone, fax number, VerDate Sep<11>2014 17:34 Mar 21, 2016 Jkt 238001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1

Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices 15313 The registrar will also accept payment Contact Person: Leroy Worth, Ph.D., Intellectual Property by major credit cards (VISA/American Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and United States Provisional Patent Express/MasterCard only). For more Application No. 60/476,467, filed June Training, Nat. Institute of Environmental information on the meeting, or for Health Sciences, P.O. Box 12233, MD EC–30/ 5, 2003, entitled ‘‘Immunogenic questions on registration, contact PDA Room 3171, Research Triangle Park, NC Peptides and Peptide Derivatives For (see FOR FURTHER INFORMATION CONTACT). 27709, (919) 541–0670, worth@niehs.nih.gov. The Treatment of Prostate And Breast B. Accommodations Name of Committee: National Institute of Cancer Treatment’’ [HHS Reference No. Environmental Health Sciences Special E–116–2003/0–US–01]; International Attendees are responsible for their Emphasis Panel; Small Business Innovation own accommodations. To make Patent Application No. PCT/US2004/ Research (SBIR) Applications Teleconference reservations, contact the Renaissance 17574 filed June 2, 2004 entitled Review. Washington Hotel (see ADDRESSES) and Date: April 7, 2016. ‘‘Immunogenic Peptides and Peptide reference ‘‘the 2016 PDA/FDA Joint Time: 1:00 p.m. to 4:00 p.m. Derivatives or The Treatment of Prostate Regulatory Conference’’ to receive the Agenda: To review and evaluate grant And Breast Cancer Treatment’’ [HHS PDA group rate. Room rates are: Single: applications. Reference No. E–116–2003/0–PCT–02]; $305 plus 14.5 percent State and local Place: NIEHS, Keystone Building, 530 United States Patent No.7,541,035, Davis Drive, Suite 3118, Research Triangle issued June 2, 2009, entitled taxes. Requests will be processed on a Park, NC 27709, (Telephone Conference first-come, first-served basis. ‘‘Immunogenic Peptides and Peptide Call). Transcripts: As soon as a transcript is Derivatives For The Treatment of Contact Person: Leroy Worth, Ph.D., available, it can be obtained in either Scientific Review Officer, Scientific Review Prostate And Breast Cancer Treatment’’ hardcopy or on CD–ROM, after Branch, Division of Extramural Research and [HHS Reference No. E–116–2003/0–US– submission of a Freedom of Information Training, Nat. Institute of Environmental 03]; United States Patent No. 8,043,623, request. The Freedom of Information Health Sciences, P.O. Box 12233, MD EC–30/ issued 25 Oct 2011, entitled office address is available on the Room 3171, Research Triangle Park, NC ‘‘Immunogenic Peptides and Peptide 27709, (919) 541–0670, worth@niehs.nih.gov. Derivatives For The Treatment of Agency’s Web site at http:// (Catalogue of Federal Domestic Assistance Prostate And Breast Cancer Treatment’’ www.fda.gov. Program Nos. 93.115, Biometry and Risk [HHS Reference No. E–116–2003/0–US– Dated: March 16, 2016. Estimation—Health Risks from 04]; United States Provisional Patent Leslie Kux, Environmental Exposures; 93.142, NIEHS Application No. 61/915,948, filed Associate Commissioner for Policy. Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund December 13, 2013, entitled ‘‘Multi- [FR Doc. 2016–06366 Filed 3–21–16; 8:45 am] Hazardous Substances—Basic Research and Epitope TARP Peptide Vaccine and BILLING CODE 4164–01–P Education; 93.894, Resources and Manpower Uses Thereof’’ [HHS Reference No. E– Development in the Environmental Health 047–2014/0–US–01]; International Sciences; 93.113, Biological Response to Patent Application No. PCT/US2014/ DEPARTMENT OF HEALTH AND Environmental Health Hazards; 93.114, 070144 filed December 12, 2014 entitled HUMAN SERVICES Applied Toxicological Research and Testing, ‘‘Multi-Epitope TARP Peptide Vaccine National Institutes of Health, HHS) and Uses Thereof’’ [HHS Reference No. National Institutes of Health Dated: March 15, 2016. E–047–2014/0–PCT–02]; and all National Institute of Environmental Carolyn Baum, continuation applications, divisional Health Sciences, Notice of Closed Program Analyst, Office of Federal Advisory applications and foreign counterpart Meetings Committee Policy. applications claiming priority to the US [FR Doc. 2016–06337 Filed 3–21–16; 8:45 am] provisional application no. 61/915, 948 Pursuant to section 10(d) of the BILLING CODE 4140–01–P and U.S. Provisional Application No. Federal Advisory Committee Act, as 62/248,964 filed October 30, 2015 titled amended (5 U.S.C. App.), notice is ‘‘Compositions and Methods for the hereby given of the following meetings. DEPARTMENT OF HEALTH AND Treatment of HER2-Expressing Solid The meetings will be closed to the HUMAN SERVICES Tumors’’ [HHS Reference No. E–187– public in accordance with the 2015/0–US–01] and continuation provisions set forth in sections National Institutes of Health applications, divisional applications 552b(c)(4) and 552b(c)(6), title 5 U.S.C., and foreign counterpart applications as amended. The grant applications and Prospective Grant of Exclusive claiming priority to the US provisional the discussions could disclose License: Development and application no. 62/248,964. confidential trade secrets or commercial Commercialization of Cancer The patent rights in these inventions property such as patentable material, Immunotherapy have been assigned to the government of and personal information concerning AGENCY: National Institutes of Health, the United States of America. individuals associated with the grant HHS. The prospective exclusive license applications, the disclosure of which ACTION: Notice. territory may be worldwide and the would constitute a clearly unwarranted field of use may be limited to the use invasion of personal privacy. SUMMARY: This notice, in accordance of Licensed Patent Rights for the Name of Committee: National Institute of with 35 U.S.C. 209 and 37 CFR part 404, following: that the National Institutes of Health, (1) Development and asabaliauskas on DSK3SPTVN1PROD with NOTICES Environmental Health Sciences Special Emphasis Panel; Evaluation of the U01 Department of Health and Human commercialization of a therapeutic Engineered Nanomaterials (ENMs) Grant Services, is contemplating the grant of cancer vaccine specifically in Applications. an exclusive patent license to practice combination with Licensee’s proprietary Date: April 4, 2016. the inventions embodied in the Time: 8:00 a.m. to 5:00 p.m. or exclusively in-licensed vectors/ Agenda: To review and evaluate grant following U.S. Patents and Patent adjuvants and ME–TARP; applications. Applications to Midissia Therapeutics (2) Development and Place: Sheraton Chapel Hill Hotel, 1 (‘‘MIDISSIA’’) located in San Francisco, commercialization of a combination Europa Drive, Chapel Hill, NC 27517. California, USA. product using Licensee’s proprietary or VerDate Sep<11>2014 17:34 Mar 21, 2016 Jkt 238001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1


Document Created: 2018-02-02 15:15:31
Document Modified: 2018-02-02 15:15:31
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 of public conference.
DatesThe public conference will be held on September 12, 2016, from 7 a.m. to 7:30 p.m.; September 13, 2016, from 7 a.m. to 9:30 p.m.; and September 14, 2016, from 7 a.m. to 12:30 p.m.
ContactWanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 150, Bethesda, MD 20814, 301-656-5900, ext. 111, FAX: 301- 986-1093, email: [email protected]; or Ken Nolan, Office of Communications, Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8629, email: [email protected]
FR Citation81 FR 15311 
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