1424 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicants, FDA 

withdrew approval of NDA 017920 for 

TAGAMET (cimetidine) Tablets in the 

Federal Register of June 8, 2011 (76 FR 

33310), and NDA 018709 for CAPOZIDE 

(captopril and hydrochlorothiazide) 

Tablets in the Federal Register of March 

19, 2012 (77 FR 16039).) 

Application No. Drug Applicant 

NDA 017920 ...... TAGAMET (cimetidine) Tablet; Oral, 200 milligram (mg); 300 

mg; 400 mg; 800 mg.

GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research 

Triangle Park, NC 27709. 

NDA 018155 ...... OPTICROM (cromolyn sodium) Solution/Drops; Ophthalmic, 

4%.

Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. 

NDA 018709 ...... CAPOZIDE (captopril and hydrochlorothiazide) Tablet; Oral, 

25 mg/15 mg; 25 mg/25 mg; 50 mg/15 mg; 50 mg/25 mg.

Apothecon Inc., P.O. Box 4500, Princeton, NJ 08543. 

NDA 018976 ...... LEVATOL (penbutolol sulfate) Tablet; Oral, 10 mg; 20 mg .... Auxilium Pharmaceuticals LLC, 640 Lee Rd., Chesterbrook, 

PA 19087. 

NDA 019958 ...... CUTIVATE (fluticasone propionate) Cream; Topical, 0.05% .. Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434, 

East Hanover, NJ 07936. 

NDA 020713 ...... MIRCETTE (desogestrel and ethinyl estradiol, and ethinyl estradiol) Tablet; Oral-28, 0.15 mg/0.02 mg; 0.01 mg.Teva Pharmaceutical Products Inc., 41 Moores Rd, P.O. Box 

4011, Frazer, PA 19355. 

NDA 021410 ...... AVANDAMET (metformin hydrochloride (HCl) and 

rosiglitazone maleate) Tablet; Oral, 500 mg/Equivalent to 1 

mg Base.

SmithKline Beecham Cork Ltd., Ireland, 2301 Renaissance 

Blvd., MC RN 0420, King of Prussia, PA 19406. 

NDA 021571 ...... IQUIX (levofloxacin) Solution/Drops; Ophthalmic, 1.5% .......... Santen Inc., 555 Gateway Dr., Napa, CA 94558. 

NDA 021726 ...... NIRAVAM (alprazolam) Orally Disintegrating Tablets; Oral, 

0.25 mg; 0.5 mg; 1 mg; 2 mg.

UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080. 

NDA 021768 ...... FLUDEOXYGLUCLOSE F–18 Injectable; Intravenous 10–100 

millicuries/milliliter.

Weill Medical College Cornell University, 516 East 72nd St., 

New York, NY 10065. 

ANDA 076699 .... PARCOPA (carbidopa and levodopa) Orally Disintegrating 

Tablets; Oral, 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 

mg.

UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080. 

ANDA 080248 .... ALBALON (naphazoline HCl) Solution/Drops; Ophthalmic, 

0.1%.

Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the Agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs and ANDAs listed in this 

document are unaffected by the 

discontinued marketing of the products 

subject to those NDAs and ANDAs. 

Additional ANDAs that refer to these 

products may also be approved by the 

Agency if they comply with relevant 

legal and regulatory requirements. If 

FDA determines that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: January 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00116 Filed 1–8–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1021] 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Site Location of Fiscal Year 2015 

Proposed Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the Web site location where 

the Agency will post two lists of 

guidance documents that the Center for 

Devices and Radiological Health (CDRH 

or the Center) is intending to publish in 

Fiscal Year (FY) 2015. In addition, FDA 

has established a docket, identified in 

brackets in the heading of this 

document, where stakeholders may 

comment on the priority of topics for 

guidance, provide comments and/or 

propose draft language for those topics, 

suggest topics for new or different 

guidance documents, and comment on 

the applicability of guidance documents 

that have issued previously. 

DATES: You may submit either electronic 

or written comments at any time. FDA 

would appreciate if stakeholders 

provide feedback by March 10, 2015. 

ADDRESSES: Submit electronic 

comments on the proposed guidance to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gadiock, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5452, Silver Spring, 

MD 20993–0002, 301–796–5736. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the Medical 

Device User Fee Amendments of 2012 

(MDUFA III), title II, Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–114), FDA agreed, in 

return for additional funding from 

industry, to meet a variety of 

quantitative and qualitative goals 

intended to help get safe and effective 

medical devices to market more quickly. 

These commitments included: 

• Annually posting a list of priority 

medical device guidance documents 

that the Agency intends to publish 

within 12 months of the date this list is 

published each fiscal year (the ‘‘A-list’’) 

and 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 1425 

• annually posting a list of device 

guidance documents that the Agency 

intends to publish, as the Agency’s 

guidance-development resources permit 

each fiscal year (the ‘‘B-list’’). 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the lists as 

explained in 21 CFR 10.115(f)(5). FDA 

has established the docket number 

(FDA–2012–N–1021) where comments 

on the FY 2015 lists, draft language for 

guidance documents on those topics, 

suggestions for new or different 

guidances, and relative priority of 

guidance documents may be submitted 

(see ADDRESSES). FDA believes this 

docket is an important tool for receiving 

information from interested parties and 

for sharing this information with the 

public. FDA anticipates that feedback 

from stakeholders, including draft 

language for guidance documents, will 

allow CDRH to better prioritize and 

more efficiently draft guidances that 

will be useful to industry and other 

stakeholders. FDA intends to update 

these lists each year. 

Similar information about planned 

guidance development is included in 

the annual Agency-wide notice issued 

under its good guidance practices 

(GGPs) (§ 10.115(f)(5)). The CDRH lists, 

however, are focused exclusively on 

device-related guidances and will be 

made available on FDA’s Web site at the 

beginning of each fiscal year from 2013 

to 2017. 

In addition to posting the lists of 

prioritized device guidance documents, 

FDA has committed to updating its Web 

site in a timely manner to reflect the 

Agency’s review of previously 

published guidance documents, 

including the deletion of guidance 

documents that no longer represent the 

Agency’s interpretation of, or policy on, 

a regulatory issue, and notation of 

guidance documents that are under 

review by the Agency. 

Fulfillment of these commitments 

will be reflected through the issuance of 

updated guidance on existing topics, 

removal of guidances that that no longer 

reflect FDA’s current thinking on a 

particular topic, and annual updates to 

the A-list and B-list announced in this 

notice. 

II. Guidance Development Process 

Workshop 

On June 5, 2014, CDRH held a public 

workshop to provide stakeholders an 

opportunity to actively engage with 

Center representatives about the 

guidance development process, provide 

transparency into guidance priority 

development, promote dialogue on 

guidance process improvements, and 

generate ideas for assessing the impact 

of guidance (http://www.fda.gov/

medicaldevices/newsevents/

workshopsconferences/

ucm394821.htm). The workshop also 

provided a forum to discuss best 

practices in guidance development, 

including public participation in 

guidance development. CDRH carefully 

considered the comments and 

suggestions provided by stakeholders. 

The following is a summary of the 

issues discussed at the workshop, 

actions the Center has taken to date in 

response to the discussions, and plans 

for implementation. 

A. Draft Guidance Documents 

A concern raised by external 

stakeholders was CDRH’s use of 

recommendations contained in draft 

guidance documents to make regulatory 

and enforcement decisions before the 

recommendations were established 

through issuance of a final guidance 

document. CDRH reaffirmed that the 

Center’s policy has always been 

consistent with the Agency’s GGPs, 

which state that a draft guidance 

document is issued for public comment 

purposes only and may not be 

implemented until finalized 

(§ 10.115(g)). However, CDRH agreed 

additional steps should be taken. 

Stakeholders requested that draft 

guidance documents be more clearly 

identified as ‘‘draft’’ to indicate to 

CDRH stakeholders and staff that they 

are not for implementation. CDRH 

revised its templates for new draft 

guidance documents by adding the 

watermark ‘‘DRAFT’’ to all pages in 

order to more conspicuously mark the 

guidance as not for implementation. 

CDRH implemented the use of the new 

templates effective August 6, 2014. 

CDRH also added the watermark 

‘‘DRAFT’’ to draft guidance documents 

issued prior to August 6, 2014. 

Stakeholders also recommended that 

CDRH’s guidance documents Web page 

(http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm) list 

draft guidances separately from those 

that had been finalized, which would 

enhance searchability. CDRH revised its 

guidance document Web page to 

include a new left navigation item for 

‘‘Draft Guidance.’’ In addition, CDRH 

removed draft guidance documents from 

the office guidance document lists and 

separated the link to ‘‘Recent Medical 

Device Guidance Documents’’ into two 

separate links: ‘‘Recent Medical Device 

Final Guidance Documents’’ and 

‘‘Recent Medical Device Draft Guidance 

Documents.’’ 

CDRH is aware there are some draft 

guidance documents that have not yet 

been finalized. In order to assure the 

timely completion or reissuance of draft 

guidances, CDRH is committing to 

performance goals for current and future 

draft guidance documents. For draft 

guidance documents issued after 

October 1, 2014, CDRH will finalize, 

withdraw, reopen the comment period, 

or issue another draft guidance on the 

topic for 80 percent of the documents 

within 3 years of the close of the 

comment period. For draft guidances for 

which CDRH does not take action 

within the initial 3 years, CDRH will 

finalize, withdraw, reopen the comment 

period, or issue another draft guidance 

on the topic within 5 years. In addition, 

in FY 2015, CDRH will finalize, 

withdraw, or reopen the comment 

period for 50 percent of existing draft 

guidances issued prior to October 1, 

2009. CDRH expects to renew or modify, 

as appropriate, these performance goals 

in FY 2016 and subsequent years. 

B. Earlier Stakeholder Involvement 

CDRH representatives discussed 

various ways in which the Center 

currently encourages participation by 

external stakeholders in the guidance 

development process. In addition to 

those described in the Background 

section, recently the Center has taken 

some new approaches to developing 

guidance documents. CDRH has held 

public workshops and panel meetings to 

solicit stakeholder feedback on both 

device-specific and policy-related 

issues. For example, this model was 

utilized for the development of the 

Design Considerations for Devices 

intended for Home Use Guidance 

(http://www.fda.gov/downloads/

MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/UCM331681.pdf) 

prior to the draft guidance’s issuance. 

However, because the resource 

implications for public meetings or 

workshops and panel meetings are very 

high, CDRH can only use these venues 

in limited cases. CDRH must judiciously 

balance various approaches to guidance 

development with meeting quantitative 

review timelines and other statutory 

obligations. 

In the case of emerging technologies, 

CDRH is using ‘‘leapfrog’’ guidances to 

provide initial recommendations 

regarding the type of information that 

would be appropriate in the review of 

emerging technologies. Information 

from external stakeholders helps CDRH 

formulate its initial thinking on the data 

necessary to support marketing approval 

or clearance of these devices. 


rljohnson on DSK3VPTVN1PROD with NOTICES
1426 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 

1The retrospective list of final guidances does not 

include: (1) Documents that are not guidances but 

were inadvertently categorized as guidance such as 

scientific publications, advisory opinions, and 

interagency agreements; (2) guidances actively 

being revised by CDRH; and (3) special controls 

documents. 

In anticipation of guidances that are 

expected to be developed, CDRH is 

posing the following questions to 

stakeholders for consideration and 

comment so that relevant future draft 

guidances on these technologies can be 

as complete and useful as possible. 

CDRH believes that stakeholder input at 

this stage and again after a draft 

guidance is issued on the topic will lead 

to a comprehensive and informed final 

guidance on the Agency’s policy for the 

technologies and processes listed below: 

1. Patient Matched Instrumentation for 

Orthopedics 

These devices are patient-specific 

instrumentation, created from patient 

imaging scans with the use of 

segmentation and planning software, to 

affect a surgeon’s surgical plan 

intraoperatively. A guidance document 

addressing the basic elements to be 

addressed in a 510(k) submission for 

patient matched instrumentation for all 

joint replacement product areas will 

help provide transparency to industry as 

to the level and types of information 

requested for review of these devices. 

• What methods are used to 

determine that all phases of the design 

process, including those that rely on 

execution by a trained employee and/or 

by software, function as intended? How 

is variability controlled across planning 

personnel and across different patient 

pathologies? 

• What impact does preoperative 

planning of the surgical procedure to 

create a guide have on implant 

performance? What parameters are 

critical to creating an effective 

preoperative plan with respect to device 

performance? Please provide a 

justification for your response. 

• How extensive is the interaction 

among the approving surgeon and the 

planning personnel when developing 

and approving a preoperative plan? 

• When the manufacturers of patientmatched instruments do not 

manufacture the implant system or have 

a formal business agreement with the 

implant manufacturer, what information 

requires monitoring to ensure that 

modifications to the implant system or 

implantation recommendations do not 

affect the performance of the patientmatched instrumentation? 

2. Medical Devices Intended for 

Aesthetic Use 

As the U.S. population continues to 

age, use of medical devices for aesthetic 

purposes is expanding. Given the 

absence of generally accepted metrics 

for selecting patients and evaluating 

medical device performance for 

aesthetic uses, there are many 

challenges in collecting and interpreting 

clinical data that might support 

clearance or approval of aesthetic-use 

devices. Another difficulty in such 

studies is understanding patients’ 

perspectives on product safety and 

effectiveness, which are important in 

defining the benefit/risk ratio for any 

new treatment. A guidance document 

on this topic would address 

development and validation of methods 

for quantitative measure of aesthetic 

improvement with minimal bias. 

Objective measures of device 

effectiveness can be difficult to develop 

and validate for endpoints involving 

aesthetic outcomes. However, tools to 

measure device effectiveness in an 

objective manner are needed in order to 

reduce bias in interpretation of study 

results. 

• Do the use of validated scales that 

depict varying degrees of change in 

body features (e.g., wrinkle severity, 

mid-face volume) result in clinically 

meaningful assessment of product 

effectiveness? Under what 

circumstances would the use of a 

validated scale not be clinically 

meaningful? 

• How can gender or ethnicityspecific tools be developed in order to 

gather clinically meaningful assessment 

of product effectiveness? 

• To what extent should emphasis be 

placed on the use of validated patientreported outcome measures in order to 

demonstrate product effectiveness? 

Should assessment of the primary 

endpoint using a validated patient 

reported outcome measure be routine? 

• Can photography methods find 

utility in assessment of product 

effectiveness and be comparable to live 

assessment when evaluating threedimensional changes in tissue volume? 

If so, are there such methods in clinical 

use? 

• Is there a role for creative or nontraditional methods (e.g., crowd 

sourcing, use of social media) in 

clinically meaningful assessment of 

product effectiveness? If so, how can 

this be accomplished? 

3. Dual 510(k) and Clinical Laboratory 

Improvements Amendments (CLIA) 

Waiver by Application 

A Dual 510(k) and CLIA Waiver by 

Application (‘‘Dual’’) is a regulatory 

submission requesting both 510(k) 

clearance and CLIA Waiver approval. 

Under the Dual program, a Dual must be 

preceded by a presubmission during 

which the strategy for addressing both 

regulatory requirements is discussed. 

After the presubmission, the Dual 510(k) 

and Waiver by Application are 

submitted as a single regulatory 

submission. A guidance document 

addressing considerations for the design 

of clinical studies used to support both 

CLIA Waiver approval and 510(k) 

clearance will provide transparency on 

the level and types of information to 

provide FDA. FDA anticipates this will 

help focus the Dual presubmissions and 

potentially shorten the review process 

for the Dual submission. 

• Of what challenges should FDA be 

aware in drafting this guidance 

document? 

Stakeholders are strongly encouraged 

to suggest guidance topics as well. In 

order to support their concept, 

commenters should state the potential 

guidance topic, reasons the guidance is 

needed, and proposed policy for FDA to 

consider on the topic. See § 10.115(f)(2). 

Ideally, commenters would develop a 

comprehensive policy in the form of a 

proposed guidance document that 

CDRH could then consider issuing as 

draft guidance, as explained in 

§ 10.115(f)(2). 

C. Applicability of Previously-Issued 

Final Guidance 

CDRH has issued over 1,000 guidance 

documents to provide stakeholders with 

the Agency’s thinking on numerous 

topics. Each guidance reflected the 

Agency’s current position at the time 

that it was issued. However, the 

guidance program has issued these 

guidances over a period greater than 20 

years, raising the question of how 

current do previously issued final 

guidances remain. CDRH has resolved to 

address this concern through a staged 

review of previously issued final 

guidances in collaboration with 

stakeholders. 

At the Web site where CDRH has 

posted the ‘‘A-list’’ and ‘‘B-list’’ for FY 

2015, CDRH has also posted a list of 

final guidance documents that issued in 

2005, 1995, and 1985.1 The Center 

would appreciate external feedback on 

whether any of these final guidances 

should be revised or withdrawn. CDRH 

intends to provide such lists annually 

through FY 2025 so that by FY 2025, 

FDA and stakeholders will have 

assessed the applicability of all 

guidances older than 10 years. For 

instance, in the annual notice for FY 

2016, CDRH expects to provide a list of 

the final guidance documents that 

issued in 2006, 1996, and 1986; the 

annual notice for FY 2017 is expected 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 1427 

to provide a list of the final guidance 

documents that issued in 2007, 1997, 

and 1987, and so on. CDRH will 

consider the information received from 

this retrospective review when 

determining priorities for updating 

guidance documents. Based upon this 

experience, CDRH will establish a 

process for ongoing periodic review of 

final guidance that takes into account 

the value provided by the review and 

the resource implications to conduct the 

review. 

Under the GGPs regulation at 

§ 10.115(f)(4), the public may, at any 

time, suggest that CDRH revise or 

withdraw an already existing guidance 

document. The suggestion should 

address why the guidance document 

should be revised or withdrawn and, if 

applicable, how it should be revised. 

Stakeholders are advised to examine the 

list or previously issued final guidances 

provided by CDRH on the annual 

agenda Web site but feedback on any 

guidance is appreciated. 

III. Web Site Location of Guidance Lists 

This notice announces the Web site 

location of the two lists of guidance 

documents which CDRH is intending to 

publish during FY 2015. To access these 

two lists, visit FDA’s Web site at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Overview/MDUFAIII/ucm321367.htm. 

We note that the Agency is not required 

to publish every guidance on either list 

if the resources needed would be to the 

detriment of meeting quantitative 

review timelines and statutory 

obligations. The Agency is not 

precluded from issuing guidance 

documents that are not on either list. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. CDRH’s experience in 

guidance development has shown that 

there are many reasons that CDRH staff 

may not complete the entire agenda of 

guidances it undertakes. Staffs are 

frequently diverted from guidance 

development to other priority activities. 

In addition, at any time new issues may 

arise to be addressed in guidance that 

could not have been anticipated at the 

time the annual list is generated. These 

may involve newly identified public 

health issues. 

IV. Request for 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: January 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00115 Filed 1–8–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

National Advisory Council on Alcohol 

Abuse and Alcoholism. 

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. 

A portion of 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 

Council on Alcohol Abuse and Alcoholism, 

National Cancer Advisory Board, and 

National Advisory Council on Drug Abuse. 

Open: February 4, 2015. 

Time: 9 a.m. to 2 p.m. 

Agenda: Presentation of NIAAA, NCI and 

NIDA Director’s Update, Concept Clearance, 

Scientific Reports, and other topics within 

the scope of the Collaborative Research on 

Addiction at NIH (CRAN). 

Place: National Institutes of Health, 5635 

Fishers Lane, Terrace Level Conference 

Room, Rockville, MD 20852. 

Contact Person: Abraham P. Bautista, 

Ph.D., Director, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, National Institutes of 

Health, 5635 Fishers Lane, Room 2085, 

Rockville, MD 20852, (301) 443–9737, 

bautista@mail.nih.gov. 

Paulette Gray, Ph.D., Director, Office of 

Extramural Research, National Cancer 

Institute, National Institutes of Health, 9609 

Medical Center Drive, Room 7W444, 

Rockville, MD 20892, (240) 276–6340, 

grayp@dea.nci.nih.gov. 

Mark Swieter, Ph.D., Acting Director, 

Office of Extramural Affairs, National 

Institute on Drug Abuse, National Institutes 

of Health, 6001 Executive Blvd., Room 4243, 

Rockville, MD 20852, (301) 435–1389, 

mswieter@nida.nih.gov. 

Name of Committee: National Advisory 

Council on Alcohol Abuse and Alcoholism. 

Closed: February 4, 2015. 

Time: 2 p.m. to 5:30 p.m. 

Agenda: Presentation of BSC intramural 

evaluation report and review of grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Terrace Level Conference 

Room, Rockville, MD 20852. 

Open: February 5, 2015. 

Time: 9 a.m. to 2 p.m. 

Agenda: Presentation of NIAAA Director’s 

report, concept clearance, scientific lectures 

and other topics on alcohol abuse and 

alcoholism of interest to the public and 

NIAAA’s stakeholders. 

Place: National Institutes of Health, 5635 

Fishers Lane, Terrace Level Conference 

Room, Rockville, MD 20852. 

Contact Person: Abraham P. Bautista, 

Ph.D., Director, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, National Institutes of 

Health, 5635 Fishers Lane, Room 2085, 

Rockville, MD 20852, (301) 443–9737, 

bautista@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the 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: http://

www.niaaa.nih.gov/AboutNIAAA/

AdvisoryCounci/Pages/default.aspx, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(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: January 5, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–00119 Filed 1–8–15; 8:45 am] 

BILLING CODE 4140–01–P 


rljohnson on DSK3VPTVN1PROD with NOTICES