67300 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

1For example, collections that collect PII to 

provide remuneration for participants of focus 

groups and cognitive laboratory studies will be 

submitted under this request. All Privacy Act 

requirements will be met. 

2As defined in OMB and agency Information 

Quality Guidelines, ‘‘influential’’ means that ‘‘an 

agency can reasonably determine that 

dissemination of the information will have or does 

have a clear and substantial impact on important 

public policies or important private sector 

decisions.’’ 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3037] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for Quantitative Testing for the 

Development of Food and Drug 

Administration Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Fax written comments on the 

collection of information by January 28, 

2019. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title ‘‘Generic Clearance for Quantitative 

Testing for the Development of FDA 

Communications.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Generic Clearance for Quantitative 

Testing for the Development of FDA 

Communications 

OMB Control Number 0910—NEW 

This notice announces the FDA 

information collection request from 

OMB for a generic clearance that will 

allow FDA to use quantitative social/ 

behavioral science data collection 

techniques (i.e., surveys and 

experimental studies) to test consumers’ 

reactions to FDA communications or 

educational messaging about FDAregulated food and cosmetic products, 

dietary supplements, and animal food 

and feed. To ensure that 

communications activities and 

educational campaigns have the highest 

potential to be received, understood, 

and accepted by those for whom they 

are intended, it is important to assess 

communications while they are under 

development. Understanding 

consumers’ attitudes, motivations, and 

behaviors in response to potential 

communications and education 

messaging plays an important role in 

improving FDA’s communications. 

If the following conditions are not 

met, FDA will submit an information 

collection request to OMB for approval 

through the normal PRA process: 

• The collections are voluntary; 

• The collections are low burden for 

participants (based on considerations of 

total burden hours, total number of 

participants, or burden hours per 

participant) and are low cost for both 

the participants and the Federal 

Government; 

• The collections are 

noncontroversial; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary 1 and is not retained; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 2

and 

• Information gathered will yield 

qualitative findings; the collections will 

not be designed or expected to yield 

statistical data or used as though the 

results are generalizable to the 

population of study. 

To obtain approval for a collection 

that meets the conditions of this generic 

clearance, an abbreviated supporting 

statement will be submitted to OMB 

along with supporting documentation 

(e.g., a copy of the survey or 

experimental design and stimuli for 

testing). 

FDA will submit individual 

quantitative collections under this 

generic clearance to OMB. Individual 

quantitative collections will also 

undergo review by FDA’s Research 

Involving Human Subjects Committee, 

senior leadership in the Center for Food 

Safety and Applied Nutrition, and PRA 

specialists. 

Respondents to this collection of 

information may include a wide range 

of consumers and other FDA 

stakeholders such as producers and 

manufacturers who are regulated under 

FDA-regulated food and cosmetic 

products, dietary supplements, and 

animal food and feed. 

In the Federal Register of September 

4, 2018 (83 FR 44888), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received no 

comments. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN, BY ANTICIPATED DATA COLLECTION METHODS

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Cognitive Interviews Screener ................................. 720 1 720 0.083 (5 minutes) 60 

Cognitive Interviews ................................................. 144 1 144 1 144 

Pre-test study screener ............................................ 2,400 1 2,400 0.083 (5 minutes) 199 

Pre-testing study ...................................................... 480 1 480 .25 (15 minutes) 120 

Self-administered surveys/experimental Studies 

Screener ............................................................... 75,000 1 75,000 0.083 (5 minutes) 6,225 

Self-Administered Surveys/Experimental Studies ... 15,000 1 15,000 .25 (15 minutes) 3,750 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67301 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN, BY ANTICIPATED DATA COLLECTION METHODS—Continued 

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Total .................................................................. ........................ ........................ ........................ .................................... 10,498 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The total estimated annual burden is 

10,498 hours. Current estimates are 

based on both historical numbers of 

participants from past projects as well 

as estimates for projects to be conducted 

in the next 3 years. The number of 

participants to be included in each new 

survey will vary, depending on the 

nature of the compliance efforts and the 

target audience. 

Dated: December 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28252 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Nurse Education and 

Practice 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: National Advisory Council on 

Nurse Education and Practice 

(NACNEP) has scheduled a public 

meeting. Information about NACNEP 

and the agenda for this meeting can be 

found on the NACNEP website at 

https://www.hrsa.gov/advisorycommittees/nursing/index.html. 

DATES: January 28, 2019, 8:30 a.m.–4:30 

p.m. and January 29, 2019, 8:30 a.m.– 

2:30 p.m. ET. 

ADDRESSES: This meeting will be held 

in-person and by teleconference and 

webinar. The address for the meeting is 

5600 Fishers Lane, Rockville, Maryland 

20857. 

• Conference call-in number: 1–888– 

455–0640; passcode: HRSA COUNCIL. 

• Webinar link: https://

hrsa.connectsolutions.com/nacnep/. 

FOR FURTHER INFORMATION CONTACT: 

Deitra W. Scott, MSN, RN, Nurse 

Consultant, Division of Nursing and 

Public Health, Bureau of Health 

Workforce, HRSA, 5600 Fishers Lane, 

11N112, Rockville, Maryland 20857; 

301–945–3113; or DScott1@hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACNEP 

provides advice and recommendations 

to the Secretary of HHS (Secretary) and 

Congress on policy issues related to the 

activities carried out under Title VIII of 

the Public Health Service (PHS) Act, 

including issues related to the nurse 

workforce, education, and practice 

improvement. NACNEP also prepares 

and submits an annual report to the 

Secretary and Congress describing its 

activities, including NACNEP’s findings 

and recommendations concerning 

activities under Title VIII, as required by 

the PHS Act. 

During the January 28–29, 2019, 

meeting, NACNEP will finalize the 15th 

Report (topic is Promoting Nursing 

Leadership in the Transition to ValueBased Care) and continue discussions 

on potential topics for its 16th Report. 

Agenda items are subject to change as 

priorities dictate. The meeting agenda 

will be available at the NACNEP website 

at least 14 days prior to the meeting. 

Refer to the NACNEP website for any 

updated information concerning the 

meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to NACNEP 

should be sent to Deitra W. Scott, Nurse 

Consultant, using the contact 

information above at least 3 business 

days prior to the meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Deitra W. Scott at the address and 

phone number listed above at least 10 

business days prior to the meeting. 

Since this meeting occurs in a federal 

government building, attendees must go 

through a security check to enter the 

building. Non-U.S. Citizen attendees 

must notify HRSA of their planned 

attendance at least 10 business days 

prior to the meeting in order to facilitate 

their entry into the building. All 

attendees are required to present 

government-issued identification prior 

to entry. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–28292 Filed 12–27–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, MD 20857; (301) 443–6593, 

or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 


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