68892 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 

1http://www.fda.gov/downloads/ForIndustry/

UserFees/GenericDrugUserFees/UCM282505.pdf. 

2http://www.fda.gov/AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/CDER/

ManualofPoliciesProcedures/. 

3https://www.federalregister.gov/articles/2014/

08/19/2014-19632/generic-drug-user-feeamendments-of-2012-public-hearing-on-policydevelopment-request-for-comments#footnote-4. 

4FDA evaluates each submitted ANDA 

individually to determine whether the ANDA can 

be received. The receipt of an ANDA means that 

FDA made a threshold determination that the 

ANDA is sufficiently complete to permit a 

substantive review. 

commitment letter enumerates the 

performance efficiencies, metric goals, 

and procedures to which FDA agreed for 

the GDUFA program (Commitment 

Letter).1 In a portion of the Commitment 

Letter relevant to this notice, FDA 

agreed to: (1) Expedite review of ANDAs 

in the year 1 and year 2 cohorts (i.e., 

those ANDAs submitted in fiscal year 

(FY) 2013 and FY2014, respectively) 

that are submitted on the first day that 

any valid paragraph IV application for 

the drug in question is submitted (firstto-file ANDA); (2) strive to review and 

act on all first-to-file ANDAs within 30 

months of submission to avoid 

inadvertent forfeiture of 180-day 

exclusivity eligibility under section 

505(j)(5)(D)(i)(IV) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(j)(5)(D)(i)(IV)); and (3) expedite 

review of ‘‘first generic’’ ANDAs for 

which there are no blocking patents or 

exclusivities. 

To help meet the goals in the 

Commitment Letter, FDA will prioritize 

ANDA reviews in conformance with the 

recently issued Manual of Policies and 

Procedures (MAPP) 5240.3 Rev. I: 

Prioritization of the Review of Original 

ANDAs, Amendments, and 

Supplements; and MAPP 5200.4: 

Criteria and Procedures for Managing 

the Review of Original ANDAs, 

Amendments and Supplements.2 These 

MAPPs contemplate FDA prioritizing its 

ANDA reviews in a manner consistent 

with the provisions of the Commitment 

Letter, which identify certain types of 

submissions, including ‘‘first generic’’ 

ANDA submissions, as representing 

public health priorities that will receive 

expedited review. The MAPPs also 

expressly describe prioritization of the 

ANDA types described previously. 

Subsequent to enactment of GDUFA, 

FDA has received informal comments 

on the Commitment Letter from several 

stakeholders that conveyed different 

understandings of the criteria for the 

‘‘first generic’’ review prioritization 

category. For example, stakeholders 

have characterized a ‘‘first generic’’ as 

the first ANDA submitted, the first 

ANDA approved, the first ANDA 

marketed, all first-to-file ANDAs, and a 

company’s ‘‘top priority’’ ANDA. 

Without clear criteria for this category, 

there is the potential for confusion and 

inconsistent review prioritization. 

On September 17, 2014, FDA’s Office 

of Generic Drugs held a public hearing 

to solicit public comment on certain 

topics related to implementation of 

GDUFA.3 The hearing provided an 

opportunity for public input on future 

policy priorities. At that hearing, FDA 

solicited comment on the specific 

criteria FDA should apply to identify an 

ANDA as a ‘‘first generic’’ eligible for 

expedited review. FDA has considered 

comments provided at that hearing and 

submitted to the related public docket. 

Today, FDA is announcing proposed 

criteria for the review prioritization 

category of ‘‘first generic’’ ANDA 

submissions. 

II. Request for Comments and 

Supporting Information 

FDA is requesting comments and 

supporting information on the following 

criteria for a ‘‘first generic’’ ANDA for 

the purposes of review prioritization. A 

first generic application is any received 

ANDA 4: (1) That is a first-to-file ANDA 

eligible for 180-day exclusivity, or for 

which there are no blocking patents or 

exclusivities; and (2) for which there is 

no previously-approved ANDA for the 

drug product. 

FDA believes that these proposed 

criteria appropriately focus FDA’s 

resources on approving as quickly as 

possible, new safe and effective generic 

drug products for patient use. The 

Agency also believes that these criteria 

are consistent with the broad scope of 

the Commitment Letter, and generally 

reflect industry intent. Finally, these 

criteria enable FDA to prioritize review 

of a pending ANDA when the date on 

which the ANDA can be approved alters 

due to changes in the patent or 

exclusivity landscape. 

We note that under these proposed 

criteria, ‘‘first generic’’ status is 

predicated largely on circumstances 

outside Agency control, and ones that 

may change while the ANDA is 

pending, for example, developments 

related to the disposition of related 

patent litigation. Accordingly, FDA also 

is seeking comments and supporting 

information on mechanisms the Agency 

could put in place to facilitate ANDA 

sponsor submission of such relevant 

information in a timely manner, in 

addition to that already required under 

the regulations. 

We also note that as a result of such 

developments, ANDA submissions that 

originally met the criteria for a ‘‘first 

generic’’ submission may no longer 

meet those criteria; for example, the 

validity of a patent may be upheld in 

litigation, thereby blocking approval 

until patent expiry. 

We thus are seeking comment on 

whether FDA should change the review 

prioritization for an ANDA that no 

longer meets the ‘‘first generic’’ criteria 

during its review. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: November 13, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27385 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Detection of Infectious Prion 

Protein by Seeded Conversion of 

Recombinant Prion Protein 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR Part 404, 

that the National Institutes of Health 

(NIH), Department of Health and Human 

Services, is contemplating the grant of 

an exclusive patent license to Amprion, 

Inc. located in Houston Texas, USA, to 

practice the inventions embodied in the 

following Patents and Patent 

Applications, each entitled ‘‘Detection 

of Infectious Prion Protein by Seeded 

Conversion of Recombinant Prion 

Protein’’: 

1. US provisional Application 60/

961,364 filed July 20, 2007 [HHS Ref. 

No. E–109–2007/0–US–01] 

2. PCT/US2008/070656, filed July 21, 

2008; [HHS Ref. No E–109–2007/1– 

PCT–01] 

3. EPC application No 08796382.3 

filed July 21, 2008 [HHS Ref. No E–109– 

2007/1–EP–03] 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 68893 

4. US Application No. 12/177,012, 

filed July 21, 2008 and issued as US 

patent 8,216,788 on July 10, 2012 [HHS 

Ref. No E–109–2007/1–US–02]; 

5. US Application No. 13/489,321, 

filed June 5, 2012 [E–109–2007/1–US– 

04]; 

6. US Application No. 14/263,703, 

filed April 28, 2014 [E–109–2007/1–US– 

011] 

The patent rights in these inventions 

have been assigned to the United States 

of America. 

The prospective exclusive licensed 

territory may be worldwide and the 

field of use may be limited to in vitro 

diagnostics of prion-associated diseases 

requiring FDA premarket approval, or 

the equivalent thereof outside of the 

United States, and USDA licensed 

veterinary diagnostics, or the 

equivalents thereof outside of the 

United States. 

DATES: Only written comments and/or 

application for a license that are 

received by the NIH Office of 

Technology Transfer on or before 11:59 

p.m. Eastern Time on December 19, 

2014 will be considered. 

ADDRESSES: Requests for a copy of the 

patents and applications, inquiries, 

comments and other materials relating 

to the contemplated license should be 

directed to: Tedd Fenn, Senior 

Licensing and Patenting Manager, Office 

of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Email: fennea@

mail.nih.gov; Telephone: 424–297– 

0336; Facsimile: 301–402–0220. 

SUPPLEMENTARY INFORMATION: The 

invention relates to methods and 

compositions for the detection of 

infectious prions and diagnosis of prion 

related diseases. Currently, available 

tests for disease-causing prions are 

incapable of detecting low 

concentrations and must be confirmed 

post-mortem. This technology enables 

rapid and economical detection of sublethal concentrations of prions by using 

recombinant protein (rPrP-sen) as a 

marker. A seeded sample polymerizes 

rPrP-sen, which is detected as an 

amplified indicator of prions in the 

sample. This assay does not require 

multiple amplification cycles unless a 

higher degree of sensitivity is required. 

This technology potentially may be 

combined with additional priondetection technologies to further 

improve the sensitivity of the assay. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR Part 404. The 

prospective exclusive license may be 

granted unless within thirty (30) days 

from the date of this published notice, 

the NIH receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR Part 404. 

Any additional applications for a 

license in the field of use, filed in 

response to this notice, will be treated 

as objections to the grant of the 

contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: November 10, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–27342 Filed 11–18–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel Targeting Latently Infected 

Cells Without Reactivation (RO1). 

Date: December 8–9, 2014. 

Time: December 8, 2014, 10:00 a.m. to 6:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

4H100, MSC 9823, 5601 Fishers Lane, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Time: December 9, 2014, 10:00 a.m. to 6:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3F100, MSC 9823, 5601 Fishers Lane, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Contact Person: Robert C. Unfer, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, Room 3F40B, MSC 9823, 

Rockville, Maryland 20892, 240–669–5035, 

unferrc@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: November 12, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–27340 Filed 11–18–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Heart, Lung, and Blood 

Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Advisory Council. 

Date: February 10, 2015. 

Open: 8:00 a.m. to 1:00 p.m. 

Agenda: To discuss program polices and 

issues, including the Asthma Guidelines 

Needs Assessment Report. This report can be 

found at http://www.nhlbi.nih.gov/health/

resources/lung/nhlbac-asthma-report.htm 

and comments may be submitted to Asthma_

Needs_Assessment_Comments@nhlbi.nih.gov 

by January 5, 2015. 

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