39442 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices 

Frequency: Annually; Affected Public: 

Private Sector: Business or other forprofits and Not-for-profit institutions 

and Individuals; Number of 

Respondents: 16; Total Annual 

Responses: 16; Total Annual Hours: 

160. (For policy questions regarding this 

collection contact Michelle Peterman at 

410–786–2591.) 

Dated: August 15, 2017. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–17495 Filed 8–17–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4069] 

Bayer Healthcare Pharmaceuticals; 

Withdrawal of Approval of a New Drug 

Application for BAYCOL (cerivastatin 

sodium) Tablets, 0.05 Milligrams, 0.1 

Milligrams, 0.2 Milligrams, 0.3 

Milligrams, 0.4 Milligrams, and 0.8 

Milligrams 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of new drug application (NDA) 

020740 for BAYCOL (cerivastatin 

sodium) tablets, 0.05 milligrams (mg), 

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 

mg, held by Bayer Healthcare 

Pharmaceuticals (Bayer). Bayer 

requested withdrawal of this 

application, and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of 

August 18, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Kristiana Brugger, Office of Regulatory 

Policy, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6262, Silver Spring, 

MD 20993, 301–796–3600. 

SUPPLEMENTARY INFORMATION: NDA 

020740 for BAYCOL (cerivastatin 

sodium) tablets, 0.05 mg, 0.1 mg, 0.2 

mg, and 0.3 mg, was received on June 

26, 1996, under section 505(b) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). FDA approved NDA 020740 

on June 26, 1997, as safe and effective 

as an adjunct to diet for the reduction 

of elevated total and LDL cholesterol 

levels in patients with primary 

hypercholesterolemia and mixed 

dyslipidemia (Frederickson Types IIa 

and IIb) when the response to dietary 

restriction of saturated fat and 

cholesterol and other nonpharmacological measures alone has 

been inadequate. Supplemental NDAs 

were received by FDA on July 17, 1998, 

for the 0.4 mg strength of the drug 

(approved on May 24, 1999) and on 

September 23, 1999, for the 0.8 mg 

strength of the drug (approved on July 

21, 2000). The most recently approved 

labeling (May 21, 2001) for this drug 

stated that: ‘‘BAYCOL® (cerivastatin 

sodium tablets) is indicated as an 

adjunct to diet to reduce elevated 

Total–C, LDL–C, apo B, and TG and to 

increase HDL–C levels in patients with 

primary hypercholesterolemia and 

mixed dyslipidemia (Fredrickson Types 

IIa and IIb) when the response to dietary 

restriction of saturated fat and 

cholesterol and other nonpharmacological measures alone has 

been inadequate.’’ 

Over time, however, reports 

associating cerivastatin with 

rhabdomyolysis, a potentially fatal 

condition involving muscle weakness, 

increased. Because of these reports, 

Bayer withdrew BAYCOL from the 

market on August 8, 2001. On January 

24, 2014, Bayer wrote to FDA asking the 

Agency to withdraw approval of NDA 

020740 under 21 CFR 314.150(d) and 

waived its opportunity for a hearing. 

Accordingly, under section 505(e) of 

the FD&C Act (21 U.S.C. 355(e)) and 

section 314.150(d), approval of NDA 

020740, and all amendments and 

supplements thereto, is withdrawn. 

Distribution of BAYCOL (cerivastatin 

sodium) tablets, 0.05 mg, 0.1 mg, 0.2 

mg, 0.3 mg, 0.4 mg, and 0.8 mg in 

interstate commerce without an 

approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the FD&C Act (21 

U.S.C. 355(a) and 331(d)). 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17510 Filed 8–17–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Mental Health 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 Advisory 

Mental Health Council. 

Date: September 14, 2017. 

Open: 9:00 a.m. to 12:45 p.m. 

Agenda: Presentation of the NIMH 

Director’s Report and discussion. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Closed: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Jean G. Noronha, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609, 301–443–3367, jnoronha@mail.nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an 

agenda and any additional information for 

the meeting will be posted when available. 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices 39443 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants, National Institutes of Health, HHS) 

Dated: August 14, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–17430 Filed 8–17–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 on 

Alcohol Abuse and Alcoholism Initial 

Review Group Epidemiology, Prevention and 

Behavior Research Review Subcommittee. 

Date: October 23, 2017. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, Terrace Level Conference 

Rooms, 5635 Fishers Lane, Rockville, MD 

20852. 

Contact Person: Anna Ghambaryan, M.D., 

Ph.D., Scientific Review Officer, Extramural 

Project Review Branch, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, National Institutes of 

Health, 5635 Fishers Lane, Room 2019, 

Rockville, MD 20852, 301–443–4032, 

anna.ghambaryan@nih.gov. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Initial 

Review Group Clinical, Treatment and 

Health Services Research Review 

Subcommittee. 

Date: November 1, 2017. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, Terrace Level Conference Room 

508, 5635 Fishers Lane, Rockville, MD 20852 

Contact Person: Ranga V. Srinivas, Ph.D. 

Chief Extramural Project Review, Branch 

National Institute on Alcohol Abuse and 

Alcoholism, National Institutes of Health, 

5365 Fishers Lane, Room 2085, Rockville, 

MD 20852, (301) 451–2067 srinivar@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards., National 

Institutes of Health, HHS) 

Dated: August 14, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–17428 Filed 8–17–17; 8:45 am] 

BILLING CODE 4140–01–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: 

Peter Soukas, J.D., (301) 594–8730; 

peter.soukas@nih.gov. Licensing 

information and copies of the patent 

applications 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. 

Development of a Transferrable 

Norwalk Virus Epitope and Detector 

Monoclonal Antibody 

Description of Technology 

Noroviruses are now recognized as 

the major cause of non-bacterial 

gastroenteritis in all age groups, and 

efforts are underway to develop an 

effective vaccine. The lack of a robust 

cell culture system for human 

noroviruses has complicated vaccine 

development. Hence, norovirus virus 

like particles (VLPs) have played an 

important role in the understanding of 

virus structure, immune response, 

antigenic diversity, and vaccine design. 

The development of monoclonal 

antibodies (MAbs) against norovirus 

VLPs has allowed the identification and 

characterization of key antigenic sites of 

the virus capsid and facilitated the 

development of diagnostic assays. 

During characterization of a panel of 

MAbs raised against Norwalk virus 

(NV), a prototype norovirus strain, the 

inventors identified a monoclonal 

antibody (MAbNV10) that proved useful 

in the identification of NV in tissue and 

in the characterization of an insertion 

site in the feline calicivirus (FCV) 

genome. The inventors mapped the 

precise binding site of the MAb by 

peptide screening and discovered that 

the epitope could be expressed when 

fused to other proteins. The sequence of 

this peptide (epitope) along with the 

detector antibody could be used as a 

new way to tag proteins for functional 

studies. The small size of the linear 

epitope, along with the strong avidity of 

the detector monoclonal antibody makes 

this system especially useful for many 

techniques, including 

immunofluorescence, Western blot, 

immunoprecipitation (including 

‘‘pulldown’’ assays), and 

immunohistochemistry. The inventors’ 

epitope system may be comparable to 

that of the HA tag of influenza virus that 

is widely used in molecular biology. 

This technology is further described 

in Parra et al., ‘‘Mapping and modeling 

of a strain-specific epitope in the 

Norwalk virus capsid inner shell,’’ 

Virology. 2016 May;492:232–41. doi: 

10.1016/j.virol.2016.02.019. Epub 2016 

Mar 21. 

Materials available for licensing 

comprise: (1) Hybridoma cell line NV10, 

(2) Plasmid expressing NV10 epitope as 

positive control, and (3) Plasmid 

expressing the NV10 scFV. 

This technology is available for 

licensing for commercial development 

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

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Diagnostics 

• Vaccines 

Competitive Advantages 

• Cross-reactive norovirus antibody 

mstockstill on DSK30JT082PROD with NOTICES