Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 78875 

with trading partners to ensure that all 

the proper product tracing information 

is provided and captured. To minimize 

possible disruptions in the distribution 

of prescription drugs in the United 

States, FDA does not intend to take 

action against trading partners who do 

not, prior to May 1, 2015, provide or 

capture the product tracing information 

required by section 582(b)(1), (c)(1), and 

(e)(1) of the FD&C Act. This compliance 

policy is limited to the requirements 

that trading partners provide and 

capture product tracing information; it 

does not extend to other requirements in 

section 582 of the FD&C Act, such as 

verification of suspect and illegitimate 

products (including quarantine, 

investigation, notification, and 

recordkeeping) or the requirement to 

engage only in transactions with 

authorized trading partners. 

II. Comments 

This guidance is for immediate 

implementation. FDA is issuing this 

guidance for immediate implementation 

in accordance with § 10.115(g)(2). 

Submit one set of either electronic or 

written comments on this guidance at 

any time. Submit electronic comments 

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. 

You should identify all comments with 

Docket No. FDA–2014–D–2254. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30608 Filed 12–30–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery (NIDA). 

SUMMARY: National Institute on Drug 

Abuse (NIDA), National Institutes of 

Health, as part of its continuing effort to 

reduce paperwork and respondent 

burden, invites the general public to 

take this opportunity to comment on the 

‘‘Generic Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery ’’ for approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et. seq.). This collection was 

developed as part of a Federal 

Government-wide effort to streamline 

the process for seeking feedback from 

the public on service delivery. This 

notice announces our intent to submit 

this collection to OMB for approval and 

solicits comments on specific aspects 

for the proposed information collection. 

To submit comments and for further 

information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Genevieve deAlmeida, 

Ph.D., Health Research Evaluator, Office 

of Science Policy and Communications, 

National Institute on Drug Abuse, NIH, 

6001 Executive Boulevard, Bethesda, 

MD, Bethesda, MD 20892–9557, or call 

non-toll-free number (301) 594–6802, or 

Email your request, including your 

address to: dealmeig@nida.nih.gov 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery (NIDA), 0925–0655, Expiration 

Date 3/31/2015, EXTENSION, National 

Institute on Drug Abuse (NIDA). 

Need and Use of Information 

Collection: The information collected 

under this clearance will be qualitative 

customer and stakeholder feedback 

information—their perceptions, 

experiences and expectations of 

services, issues with service, to focus 

attention on areas where 

communication, training or changes in 

operations might improve delivery of 

products or services. The information 

will be useful and will allow for 

collaborative and actionable 

communications between the Agency 

and its customers and stakeholders, and 

will contribute directly to improving the 

programs and management of them. 

The information will not yield data 

that can be generalized to the overall 

population. The information may also 

be formative for the purpose of 

developing a concept for a new service 

program or dissemination program. The 

collections may still be eligible for 

submission for other generic 

mechanisms designed to yield 

quantitative results. 

The primary objectives are to obtain 

feedback on programs from customers 

and stakeholders, that would help make 

positive changes to the programs, or to 

assist in developing a new program or 

dissemination initiative, or to test 

medical tools and devices for usability, 

feasibility, and pilot testing of survey 

questionnaires for understandability. 

Data collection methods to be used in 

these studies include web-based and 

mailed surveys, focus groups, 

interviews with small groups, ad hoc 

collections at Conferences. The findings 

will provide valuable information to 

assist in improving programs that serve 

the public, and in developing good tools 

and devices to serve the public. OMB 

approval is requested for 3 years. 

NIDA will only submit a collection for 

approval under this generic clearance if 

it meets the following conditions: 

• The collections are voluntary; 

• The collections are low-burden for 

respondents (based on considerations of 

total burden hours, total number of 

respondents, or burden-hours per 

respondent) and are low-cost for both 

the respondents and the Federal 

Government; 

• The collections are noncontroversial and do not raise issues of 

concern to other Federal agencies; 

• Any collection is targeted to the 

solicitation of opinions from 

respondents who have experience with 

the program or may have experience 

with the program in the near future; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary and is not retained; 

• Information gathered will be used 

only internally for general service 

improvement and program management 

purposes and is not intended for release 

outside of the agency; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 

and 

• Information gathered will yield 

qualitative information; the collections 

will not be designed or expected to 

yield statistically reliable results or used 

as though the results are generalizable to 

the population of study. 

Feedback collected under this generic 

clearance provides useful information, 

but it does not yield data that can be 

generalized to the overall population. 

This type of generic clearance for 

qualitative information will not be used 

for quantitative information collections 

that are designed to yield reliably 

actionable results, such as monitoring 

trends over time or documenting 

program performance. Such data uses 

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78876 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 

require more rigorous designs that 

address: The target population to which 

generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior to 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

As a general matter, information 

collections will not result in any new 

system of records containing privacy 

information and will not ask questions 

of a sensitive nature, such as sexual 

behavior and attitudes, religious beliefs, 

and other matters that are commonly 

considered private. 

Request for Comments: Comments 

submitted in response to this notice will 

be summarized and/or included in the 

request for OMB approval. Comments 

are invited on: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology; 

and (e) estimates of capital or start-up 

costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid 

Office of Management and Budget 

control number. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

1,312. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of collection Number of 

respondents 

Annual 

frequency per 

response 

Hours per 

response Total hours 

Customer outcomes and usability testing ........................................................ 888 1 40/60 592 

Customer Satisfaction and needs assessment survey ................................... 600 1 40/60 400 

Focus Groups .................................................................................................. 60 1 1 60 

Small Discussion Groups ................................................................................. 60 1 1 60 

Pilot Testing of instruments for applicability among diverse populations ....... 300 1 40/60 200 

Total ................................................................................................................. ........................ ........................ ........................ 1,312 

Dated: December 24, 2014. 

Genevieve deAlmeida, 

Project Clearance Liaison, NIDA, NIH. 

[FR Doc. 2014–30656 Filed 12–30–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60 Day Comment 

Request Prevalence, Incidence, 

Epidemiology and Molecular Variants 

of HIV in Blood Donors in Brazil 

(NHLBI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Simone Glynn, MD, 

Project Officer/ICD Contact, Two 

Rockledge Center, Suite 9142, 6701 

Rockledge Drive, Bethesda, MD 20892, 

or call non-toll-free number (301)–435– 

0065, or Email your request to: glynnsa@

nhlbi.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Prevalence, 

Incidence, Epidemiology and Molecular 

Variants of HIV in Blood Donors in 

Brazil 0925–0597 expiration date, July 

31, 2015, Extension, National Heart, 

Lung, and Blood Institute (NHLBI), the 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: Establishing and monitoring 

viral prevalence and incidence rates, 

and identifying behavioral risk 

behaviors for HIV infection among 

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