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should be revised or withdrawn and, if 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] 

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