Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 509 

FDA also provides recommendations on 

how to prioritize reporting when 

regulatory timelines cannot be met due 

to limited resources during a pandemic, 

so that FDA continues to receive critical 

safety information in a timely manner. 

For example, table 1 of the guidance 

outlines how companies should 

prioritize their submission of 

postmarketing safety reports during an 

influenza pandemic if normal processes 

of mandatory adverse event reporting 

are not feasible because of high 

employee absenteeism: Reports for 

pandemic influenza vaccines, drugs and 

biological products labeled for the 

treatment of influenza, drugs and 

biologics approved for less than three 

years, and products with special 

concerns as specified by FDA. The list 

includes reporting on newly approved 

products as the comment recommended. 

The guidance provides resources for 

companies establishing a COOP plan, 

but specifying the content of the COOP 

plans as suggested by the comment is 

beyond the scope of the guidance. 

Instead, the guidance provides the more 

general recommendation that ‘‘each 

firm’s pandemic influenza COOP plan 

should include instructions for 

reporting adverse events and the 

submission of any stored reports not 

submitted in the regulatory timeframes’’ 

(see section III.B, page 2). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of reporting Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeper 

Total hours 

Add adverse event reporting plan to COOP ....................... 5,000 1 5,000 50 250,000 

Maintain documentation of influenza pandemic conditions 

and resultant high absenteeism ....................................... 500 1 500 8 4,000 

Maintain records to identify what reports have been stored 

and when the reporting process was restored ................ 500 1 500 8 4,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 258,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: December 30, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30907 Filed 1–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–P–0980] 

Determination That REYATAZ 

(Atazanavir Sulfate) Capsules, 100 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that REYATAZ (atazanavir 

sulfate) capsules, 100 milligrams (mg), 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for atazanavir 

sulfate, 100 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Na’Im R. Moses, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6224, 

Silver Spring, MD 20993–0002, 240– 

402–3990. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

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

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

REYATAZ (atazanavir sulfate) 

capsules, 100 mg, is the subject of NDA 

21–567, held by Bristol-Myers Squibb, 

and initially approved on June 20, 2003. 


tkelley on DSK3SPTVN1PROD with NOTICES
510 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 

REYATAZ is a protease inhibitor 

indicated for use in combination with 

other antiretroviral agents for the 

treatment of human immunodeficiency 

virus (HIV–1) infection in patients 3 

months and older weighing at least 10 

kilograms. 

In a letter dated August 19, 2014, 

Bristol-Myers Squibb notified FDA that 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, had been discontinued. The 

REYATAZ 150-, 200-, and 300-mg 

capsule strengths continue to be 

marketed by Bristol-Myers Squibb. The 

100-mg dosage strength of this drug 

product is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated July 

7, 2014 (Docket No. FDA–2014–P– 

0980), under 21 CFR 10.30, requesting 

that the Agency determine whether 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, were withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REYATAZ (atazanavir 

sulfate) capsules, 100 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that REYATAZ (atazanavir 

sulfate) capsules, 100 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

REYATAZ (atazanavir sulfate) capsules, 

100 mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that the product was not 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REYATAZ (atazanavir 

sulfate) capsules, 100 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to REYATAZ (atazanavir sulfate) 

capsules, 100 mg, may be approved by 

the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: December 30, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30909 Filed 1–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Her2 Monoclonal Antibodies, 

Antibody Drug Conjugates, and Site 

Specific Antibody Conjugate Methods 

for the Treatment of Cancer 

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, 

Department of Health and Human 

Services, is contemplating the grant of 

an exclusive patent license to HUIYU 

Pharmaceuticals Co, Ltd located in 

Neijiang City, CHINA to practice the 

inventions embodied in U.S. Provisional 

Patent Application 61/833,732, filed 

June 11, 2013 entitled ‘‘Her2-Specific 

Monoclonal Antibodies and Conjugates 

Thereof’’ [HHS Ref. No.: E–351–2013/0– 

US–01], and International Application 

PCT/US2014/041492, filed June 9, 2014 

entitled ‘‘Her2-Specific Monoclonal 

Antibodies and Conjugates Thereof’’ 

[HHS Ref. No.: E–351–2013/0–PCT–02], 

any PCT, US or foreign applications 

claiming the benefit of. The patent 

rights in these inventions have been 

assigned to the Government of the 

United States of America. 

The prospective exclusive license 

territory may be limited to China, and 

the field of use may be limited to: 

The use of the m860 monoclonal 

antibodies as mono-specific antibodies; or 

targeting moieties for immunoconjugates, 

wherein the antibodies are conjugated to 

auristatin F and analogues thereof, for the 

treatment of HER2 positive cancers. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before 

February 5, 2015 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Eggerton Campbell, Ph.D. 

Licensing and Patenting Manager, 

Cancer Branch, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–5282; Facsimile: (301) 435– 

4013; Email: 

Eggerton.Campbell@nih.gov. 

SUPPLEMENTARY INFORMATION: These 

inventions concern Antibody Drug 

Conjugates (ADCs). ADCs can 

demonstrate high efficacy as cancer 

therapeutics, however, much more can 

be done to improve their efficacy and 

safety profile. Site-specific antibody 

drug conjugation is a promising way to 

do this. 

The scientists at the NIH have 

identified a fully human monoclonal 

antibody, m860, that binds to cell 

surface-associated Her2 with affinity 

comparable to that of Trastuzumab 

(Herceptin) but to a different epitope. In 

addition, the scientist developed a sitespecific glycan engineering method to 

conjugate the antibody to the small 

molecule drug auristatin F. The ADC 

prepared though this site-specific 

approach shows very good stability, cell 

surface binding activity and also potent 

specific cell killing activity against Her2 

positive cancer cells, including 

Trastuzumab resistant breast cancer 

cells. This ADC has the potential to be 

developed as a targeted therapeutic for 

Her2-overexpressing cancers. 

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 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 

within thirty (30) days from the date of 

this published notice. 

Applications for a license in the field 

of use that are 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: December 30, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–30878 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 


tkelley on DSK3SPTVN1PROD with NOTICES