8886 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

1The NDC number of the original approved drug 

product should not be placed on the repackaged 

drug product. 

• A statement of either the quantity or 

volume of the repackaged drug product, 

whichever is appropriate. 

• The date the drug product was 

repackaged. 

• The beyond-use-date of the 

repackaged drug product. 

• Storage and handling instructions 

for the repackaged drug product. 

• The National Drug Code (NDC) 

number of the repackaged drug product, 

if available.1

• The statement ‘‘Not for resale,’’ and, 

if the drug is distributed by an 

outsourcing facility other than pursuant 

to a prescription for an individual 

identified patient, the statement ‘‘Office 

Use Only.’’ 

• If included on the label of the FDAapproved drug product from which the 

drug product is being repackaged, a list 

of the active and inactive ingredients, 

unless such information is included on 

the label for the container from which 

the individual units are removed, as 

described in this document. 

In addition, a condition in the draft 

guidance is that the label on the 

container from which the individual 

units are removed for administration 

(secondary packaging, e.g., the bag, box, 

or other package in which the 

repackaged products are distributed) 

includes the active and inactive 

ingredients, if the immediate product 

label is too small to include this 

information, and directions for use, 

including, as appropriate, dosage and 

administration, and the following 

information to facilitate adverse event 

reporting: http://www.fda.gov/

medwatch and 1–800–FDA–1088. 

Another condition in the draft 

guidance is that each repackaged drug 

product is accompanied by a copy of the 

prescribing information that 

accompanied the original drug product 

that was repackaged. 

We estimate that annually a total of 

approximately 10 outsourcing facilities 

(‘‘Number of Respondents’’ in table 1, 

row 1) will each design, test, and 

produce approximately 10 different 

labels (‘‘Frequency per Disclosure’’ in 

table 1, row 1) for a total of 100 labels 

that include the information set forth in 

section III.A.11 of the draft guidance 

(including directions for use) (‘‘Total 

Disclosures’’ in table 1, row 1). We also 

estimate that designing, testing, and 

producing each label will take 

approximately 0.5 hours for each 

repackaged drug product (‘‘Hours per 

Disclosure’’ in table 1, row 1). The 

provision to add the statement http://

www.fda.gov/medwatch and 1–800– 

FDA–1088 is not included in this 

burden estimate because it is not 

considered a collection of information 

under the PRA because the information 

is ‘‘originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). 

We also estimate that annually a total 

of approximately 10 outsourcing 

facilities (‘‘Number of Respondents’’ in 

table 1, row 2) will each produce a copy 

of prescribing information as set forth in 

section III.A.11 of the draft guidance for 

approximately 10 repackaged drug 

products (‘‘Frequency per Disclosure’’ 

in table 1, row 1) for a total of 100 

disclosures (‘‘total disclosures’’ in table 

1, row 2). We also estimate that 

providing prescribing information 

labeling will take approximately 1 hour 

for each repackaged drug product 

(‘‘Hours per Disclosure’’ in table 1, row 

2). The provision to add http://

www.fda.gov/medwatch and 1–800– 

FDA–1088 is not included in this 

burden estimate because it is not 

considered a collection of information 

under the PRA because the information 

is ‘‘originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). 

The total estimated third-party 

disclosure burden resulting from the 

draft guidance is as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN

Repackaging by outsourcing facilities Number of 

respondents 

Frequency per 

disclosure 

Total 

disclosures 

Hours per 

disclosure Total hours 

Designing, testing, and producing each label on immediate 

containers, packages and/or outer containers ................. 10 10 100 .5 50 

Prescribing information labeling produced for each repackaged drug product ............................................................ 10 10 100 1 100 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

*(30 minutes) 

The draft guidance also references 

registration, product reporting, and 

CGMP requirements for outsourcing 

facilities. In the Federal Register of 

December 4, 2013 (78 FR 72899), FDA 

estimated the burden resulting from 

outsourcing facility registration. In the 

Federal Register of December 4, 2013 

(78 FR 72897), FDA estimated the 

burden resulting from outsourcing 

facility interim product reporting. In the 

Federal Register of July 2, 2014 (79 FR 

37743), FDA estimated the burden 

resulting from outsourcing facility 

compliance with CGMP requirements. 

V. Electronic Access 

Persons with access to the Internet 

can obtain the document at either http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03417 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Health Information 

National Trends Survey (HINTS) (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8887 

listed below. This proposed information 

collection was previously published in 

the Federal Register on December 4, 

2014 (Vol. 79, No. 233, pages 72003— 

4) and allowed 60 days for public 

comment. A total of five public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments To OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

DATES: Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Bradford W. Hesse, Ph.D., 

Health Communication and Informatics 

Research Branch, 9609 Medical Center 

Drive, MSC 9761, Room 3E610, 

Rockville, MD 20850 or call non-toll 

free number 240–276–6721 or Email 

your request, including your address, to 

hesseb@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

Proposed Collection: Health 

Information National Trends Survey 

(HINTS) 0925–0538, Reinstatement with 

Change, National Cancer Institute (NCI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: This partnership between 

NCI and FDA will include assessing the 

public’s knowledge of medical devices, 

communications related to product 

recalls, nutritional supplement labeling, 

and topics to inform FDA’s regulatory 

authority over tobacco, such as risk 

perceptions about new tobacco 

products, product pack color gradations, 

perceptions of product harm, and 

tobacco product claims and labels. This 

HINTS survey will couple knowledgerelated questions with inquiries into the 

communication channels through which 

understanding is being obtained, and 

assessment of FDA-regulated material. 

This survey will extend the information 

collected and priorities from HINTS 

which have been to provide a 

comprehensive assessment of the 

American public’s current access to, and 

use of, information about cancer across 

the cancer care continuum from cancer 

prevention, early detection, diagnosis, 

treatment, and survivorship. 

OMB approval is requested for 1 year. 

There are no costs to respondents other 

than their time. The total estimated 

annualized burden hours are 2,159. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Number of 

respondents 

Number of 

responses 

per respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Individuals ........................................................................................................ 4,318 1 30/60 2,159 

Dated: February 9, 2015. 

Karla Bailey, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2015–03382 Filed 2–18–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Short-term Educational Experiences in 

Hematology. 

Date: March 11, 2015. 

Time: 8:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda; One 

Bethesda Metro Center; 7400 Wisconsin 

Avenue; Bethesda, MD 20814. 

Contact Person: Melissa E Nagelin, Ph.D.; 

Scientific Review Officer; Office of Scientific 

Review/DERA; National Heart, Lung, and 

Blood Institute; 6701 Rockledge Drive; Room 

7202; Bethesda, MD 20892; 301–435–0297; 

nagelinmh2@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

International Strategic Timing of 

Antiretroviral Therapy. 

Date: March 13, 2015. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health; 6705 

Rockledge Drive, Room 7188; Bethesda, MD 

20817; (Telephone Conference Call). 

Contact Person: Chang Sook Kim, Ph.D.; 

Scientific Review Officer; Office of Scientific 

Review/DERA; National Heart, Lung, and 

Blood Institute; 6701 Rockledge Drive; Room 

7188; Bethesda, MD 20892–7924; 301–435– 

0287; carolko@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS). 

Dated: February 12, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–03344 Filed 2–18–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 


emcdonald on DSK67QTVN1PROD with NOTICES