Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39453 

on the label (2,160 ¥ 1,140 = 1,020 

products not organics; 540 ¥ 285 = 255 

manufacturers of not organic products). 

In addition, the 54 livestock feed 

suppliers are also organic producers, 

thus the 216 products attributed to these 

manufacturers already are considered to 

be labeled ‘‘organic.’’ Thus, there are 

1,020 products made by 255 human 

food and pet food manufacturers that 

would need to substantiate that their 

product or ingredient was not 

genetically engineered. 

We estimate that the burden of 

maintaining the documentation is a onetime burden; the document to 

substantiate that the product or 

ingredient was produced without 

genetic engineering only needs to be 

generated once and then kept on file. To 

annualize this one-time burden, we 

divide by 3 because paperwork burden 

collections are approved on a 3-year 

cycle (255/3 = 85). Thus, we estimate in 

table 1 that, on average, 85 

manufacturers annually will collect and 

keep information that substantiates their 

label claim for four products (1,020 

products/3 = 340 products/85 

manufacturers = 4 products per 

manufacturer). 

We estimate this one-time 

recordkeeping burden to be 1 hour per 

product that makes use of a labeling 

claim, which results in a burden of 1 

hour for a total annualized 

recordkeeping burden of 340 hours (85 

manufacturers × 4 records per 

manufacturer × 1 hour per record). 

We do not estimate any reporting 

burden or third-party disclosure burden 

associated with this information 

collection. Manufacturers who want to 

make use of this voluntary labeling 

claim option are considered to be those 

that already have such wording on their 

products’ labels. We do not expect that 

this guidance will cause labels already 

in the marketplace to need to be 

reworded. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17024 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–0998] 

Determination That PROLIXIN 

(Fluphenazine Hydrochloride) Tablets, 

1 Milligram, 2.5 Milligrams, 5 

Milligrams, and 10 Milligrams, Was 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Withdrawn From Sale for Reasons of 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 PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

milligram (mg), 2.5 mg, 5 mg, and 10 

mg, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for fluphenazine 

hydrochloride tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

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 an 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. 

PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, is the subject of NDA 

011751, held by Apothecon 

Pharmaceuticals, a Bristol-Myers Squibb 

Company, and initially approved on 

March 15, 1967. PROLIXIN is indicated 

in the management of manifestations of 

psychotic disorders. 

In a letter dated October 5, 2006, 

Bristol-Myers Squibb Company 

requested withdrawal of NDA 011751 

for PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg. In the Federal Register 

of February 11, 2009 (74 FR 6896), FDA 

announced that it was withdrawing 

approval of NDA 011751, effective 

March 13, 2009. 

Hyman, Phelps & McNamara, P.C. 

submitted a citizen petition dated 

March 5, 2018 (Docket No. FDA–2018– 

P–0998), under 21 CFR 10.30, 

requesting that the Agency determine 

whether PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, was 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 PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, was not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 


sradovich on DSK3GMQ082PROD with NOTICES
39454 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 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 PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 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: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17026 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Amy F. Petrik, Ph.D., 240–627–3721, 

amy.petrik@nih.gov. Licensing 

information and copies of the U.S. 

patent application listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Stabilized Group 2 Influenza 

Hemagglutinin Stem Region Trimers 

and Uses Thereof 

Description of Technology: 

Researchers at the Vaccine Research 

Center of the National Institute of 

Allergy and Infectious Diseases (NIAID) 

have designed influenza vaccine 

candidates based on group 2 influenza 

hemagglutinin (HA) proteins. These 

group 2 HA proteins were engineered to 

remove the highly variable head region 

and stabilize the remaining stem region. 

The researchers then fused the 

engineered group 2 HA stabilized stem 

with a ferritin subunit. The resulting 

fusion protein can self-assemble into 

nanoparticles which display group 2 HA 

stem domain trimers on their surface. 

These immunogens elicit crossreactive antibodies to group 2 influenza 

viruses and could be used in 

combination with group 1 HA stemferritin immunogens as a universal 

influenza vaccine. Interestingly, a recent 

study by Andrews et al., Sci. Immunol. 

2, eaan2676 (2017), suggests that crossreactive group 1/group 2 HA stem 

antibodies may be more likely to be 

elicited in humans by a group 2 HA 

immunogen. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404. 

Potential Commercial Applications: 

• Use as a broadly protective influenza 

vaccine 

Competitive Advantages: 

• Elicits antibodies to both group 1 and 

group 2 influenza A viruses 

• Nucleic acid or recombinant proteinbased vaccine 

• Increased ease of production 

compared to current seasonal 

influenza vaccines 

Development Stage: 

• In vivo (animal studies) 

Inventors: Jeffrey C. Boyington, 

Barney S. Graham, John R. Mascola, 

Hadi M. Yassine, Syed M. Moin, 

Lingshu Wang, Kizzmekia S. Corbett, 

Masaru Kanekiyo (all from NIAID). 

Intellectual Property: HHS Reference 

Number E–228–2016 includes U.S. 

Provisional 62/383,267 filed 2 

September 2016 and PCT Patent 

Application No. PCT/US2017/049894 

filed 1 September 2017 (pending). 

Related Intellectual Property: HHS 

Reference Number E–293–2011. 

Licensing Contact: Dr. Amy Petrik, 

240–627–3721; amy.petrik@nih.gov. 

Dated: July 25, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[1651–0138] 

Agency Information Collection 

Activities: Biometric Identity 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 30-Day notice and request for 

comments; revision and extension of an 

existing collection of information. 

SUMMARY: The Department of Homeland 

Security, U.S. Customs and Border 

Protection will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995 (PRA). The 

information collection is published in 

the Federal Register to obtain comments 

from the public and affected agencies. 

DATES: Comments are encouraged and 

will be accepted (no later than 

September 10, 2018]) to be assured of 

consideration. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to dhsdeskofficer@

omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional PRA information 

should be directed to Seth Renkema, 

Chief, Economic Impact Analysis 

Branch, U.S. Customs and Border 

Protection, Office of Trade, Regulations 

and Rulings, 90 K Street NE, 10th Floor, 

Washington, DC 20229–1177, 

Telephone number (202) 325–0056 or 

via email CBP_PRA@cbp.dhs.gov. Please 

note that the contact information 

provided here is solely for questions 

regarding this notice. Individuals 

seeking information about other CBP 

programs should contact the CBP 

National Customer Service Center at 

877–227–5511, (TTY) 1–800–877–8339, 


sradovich on DSK3GMQ082PROD with NOTICES