Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43761 

and toolkits for LHDs and community 

groups so that they can align their 

efforts and strengthen the benefits and 

positive impacts of citizen science 

activities. For interviews, the 

information collection will target citizen 

scientists and end users of citizen 

science data. 

Citizen science is defined as research 

activities (e.g., data collection, analysis, 

and reporting) performed by members of 

the general public without any 

particular training in science. Citizen 

science is growing in popularity, fueled 

in part by growing use of smartphones 

and other personal devices in the 

population. Although citizen collection 

and use of data during disasters has 

increased exponentially in recent years 

and there is great policy interest in the 

phenomenon, there has been no robust 

research to date on the use of, barriers 

to, and impact of citizen science in 

disasters. Local health departments 

(LHDs) lack tools to respond to and 

coordinate with citizen science 

activities within communities. 

Furthermore, citizen science 

organizations lack information on how 

to organize their activities for ultimate 

impact. 

This is an exploratory study and is the 

first of its kind to explore the growing 

phenomenon of disaster citizen science. 

Disaster citizen science is a rapidly 

growing field that is the focus of policy 

interest, but currently devoid of 

research. This study will generate 

information that can help define the 

phenomenon of disaster citizen science 

and may result in nationally 

representative baseline data that can 

support changes in citizen science 

awareness, barriers, and activities. 

While interviews will be hypothesis 

generating and provide rich data on the 

experiences with citizen science to date 

across all stakeholders active in this 

enterprise, the nationally-representative 

survey data will allow us to generalize 

findings to the full population of LHDs 

in the U.S. 

CDC will collaborate with a contractor 

to implement this project. Researchers 

will target citizen scientists and their 

partners (e.g., academics who work with 

citizen scientists on research projects) 

and LHDs in a position to use citizen 

science data to inform public health 

decision-making. For interviews, 

researchers will sample for maximum 

variation, seeking to obtain variation on 

U.S. region, type and sophistication of 

citizen science project, type of disaster 

encountered, and previous experience 

with disaster citizen science. 

The researchers aim to conduct 35–55 

individual and group facilitated semistructured interviews, each lasting 

approximately 60 minutes, to cover 

topics including benefits and uses of 

citizen science, barriers to and 

facilitators of citizen science, and 

strengths and limitations of citizen 

science activities and resources. 

Researchers will identify potential 

interview participants through literature 

reviews and snowball sampling in a 

phased approach starting with citizen 

science and LHD organizations. 

Researchers will sample for maximum 

variation in order to capture the full 

range of citizen scientist and health 

department experiences on this topic. 

For the survey, the researchers will 

target a nationally representative sample 

of 600 local health officials and will 

apply survey weights to ensure that 

findings have external validity and can 

be generalized to LHDs in the U.S. The 

survey, which will take 30 minutes to 

complete, will include questions on 

both citizen science as applied to 

disaster preparedness and response, and 

citizen science as occurring in other 

contexts (such as environmental 

health)to draw lessons for preparedness 

and response. 

OPHPR anticipates that the 

knowledge resulting from this research 

project will contribute significantly to 

the evidence base for preparedness and 

response and lead to improved 

efficiency, effectiveness, and outcomes 

in several domains. 

Participation in this study is 

voluntary. There are no costs to 

respondents other than their time. A 

summary of annualized burden hours is 

below. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Citizen scientists and their partners; 

local health officials.

Interview Guide (semi-structured 

questionnaire).

55 1 75/60 69 

Local health departments ................. Survey .............................................. 300 1 30/60 150 

Total ........................................... ........................................................... ........................ ........................ ........................ 219 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–19824 Filed 9–18–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0192] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Establishing and 

Maintaining Lists of United States 

Manufacturers/Processors With 

Interest in Exporting Center for Food 

Safety and Applied Nutrition-Regulated 

Products to China 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions found in the 


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43762 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

guidance entitled ‘‘Establishing and 

Maintaining a List of U.S. Milk and Milk 

Product, Seafood, Infant Formula, and 

Formula for Young Children 

Manufacturers/Processors with Interest 

in Exporting to China: Guidance for 

Industry.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 20, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 20, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 20, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–0192 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Establishing and Maintaining Lists of 

U.S. Manufacturers/Processors with 

Interest in Exporting CFSAN-Regulated 

Products to China.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff Office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://www.

regulations.gov and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Establishing and Maintaining Lists of 

U.S. Manufacturers/Processors With 

Interest in Exporting CFSAN-Regulated 

Products to China—21 U.S.C. 371 

OMB Control Number 0910–0839— 

Extension 

The United States exports a large 

volume and variety of foods in 

international trade. For certain food 

products, foreign governments may 

require assurances from the responsible 

authority of the country of origin of an 

imported food product that the 

manufacturer/processor of the food 


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Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43763 

product is in compliance with 

applicable country of origin regulatory 

requirements. Some foreign 

governments establish additional 

requirements with which exporters are 

required to comply. 

In August 2011, China’s State General 

Administration of the People’s Republic 

of China for Quality Supervision, 

Inspection, and Quarantine (AQSIQ) 

published the ‘‘Administrative 

Measures for Registration of Overseas 

Manufacturers,’’ known as AQSIQ 

Decree 145 (https://gain.fas.usda.gov/

Recent%20GAIN%20Publications/

Registration%20of%20Overseas%20

Food%20Manufacturing%20Facilities

%20_Beijing_China%20-%20

Peoples%20Republic%20of_6-27-

2012.pdf), which became effective May 

1, 2012. AQSIQ Decree 145, among 

other requirements, mandates that 

foreign competent authorities provide 

the Certification and Accreditation 

Administration of China (CNCA) with a 

name list of overseas manufacturers of 

imported food applying for registration 

with CNCA for each commodity that 

CNCA has deemed to require 

registration. As of June 2017, milk and 

milk products, seafood, infant formula, 

and formula for young children are 

among the commodities for which 

CNCA requires registration of overseas 

manufacturers under AQSIQ Decree 

145. CNCA has recognized FDA/Center 

for Food Safety and Applied Nutrition 

(CFSAN) as the competent food safety 

authority in the United States to 

establish and maintain lists of U.S. 

establishments that intend to export 

U.S. milk and milk products, seafood, 

infant formula, and/or formula for 

young children to China, including the 

corresponding products manufactured 

by each establishment and intended for 

export to China. In order to implement 

AQSIQ Decree 145, FDA and CNCA 

entered into a Memorandum of 

Understanding (China MOU) on June 

15, 2017, which sets out the two 

agencies’ intent to facilitate the 

conditions under which U.S. 

manufacturers/processors can export to 

China milk and milk products, seafood, 

infant formula, and/or formula for 

young children. 

Under the China MOU, FDA intends 

to establish and maintain lists that 

identify U.S. manufacturers/processors 

that have expressed interest to FDA in 

exporting milk and milk products, 

seafood, infant formula, and/or formula 

for young children to China; are subject 

to our jurisdiction; and have been found 

by FDA to be in good regulatory 

standing with FDA, including a finding 

by FDA that, during the most recent 

facility inspection, the manufacturers/ 

processors have been found to be in 

substantial compliance with all 

applicable FDA regulations, including, 

but not limited to, current good 

manufacturing practice requirements for 

the identified products for export to 

China. Further, the China MOU 

provides for FDA to receive evidence 

that the manufacturer/processor has 

been certified by a third-party 

certification body—as acknowledged by 

CNCA—to meet the relevant standards, 

laws, and regulations of China for the 

identified food products for export to 

China. On June 28, 2017, FDA issued a 

guidance document entitled, 

‘‘Establishing and Maintaining a List of 

U.S. Milk and Milk Product, Seafood, 

Infant Formula, and Formula for Young 

Children Manufacturers/Processors with 

Interest in Exporting to China: Guidance 

for Industry’’ which can be found at 

https://www.fda.gov/Food/

GuidanceRegulation/

GuidanceDocumentsRegulatory

Information/ucm378777.htm. The 

guidance informs industry of 

information that FDA and CNCA will 

collect to manage the listing of these 

manufacturers/processors and foods for 

export to China pursuant to AQSIQ 

Decree 145 and the China MOU. 

In accordance with 5 CFR 1320.13, 

FDA requested emergency review and 

approval of the collections of 

information found in the guidance 

document. The routine course of 

approval would have delayed our ability 

to collect the information from firms 

and, thus, would have been disruptive 

in our efforts to facilitate exports of food 

in compliance with requirements 

established by China in AQSIQ Decree 

145. OMB granted the approval under 

emergency clearance procedures on 

June 27, 2017. 

FDA uses the information submitted 

by manufacturers/processors to consider 

them for inclusion on FDA’s lists of 

eligible manufacturers/processors that 

may ship food products to China, which 

we maintain. Updates to the FDA lists 

are sent to CNCA, which publishes 

quarterly its version of the information 

in the FDA lists on China’s Web site 

(http://english.cnca.gov.cn/). The 

purpose of the lists is to assist China in 

its determination of which U.S. milk 

and milk product, seafood, infant 

formula, or formula for young children 

manufacturers/processors are eligible to 

import these products into China under 

applicable Chinese law. Currently FDA 

maintains lists for milk and milk 

product, seafood, infant formula, and 

formula for young children but FDA 

wants to be prepared if CNCA requires 

listing of manufacturers/processors of 

other CFSAN-regulated products in the 

future. As such, the information 

collection request is not limited to milk 

and milk product, seafood, infant 

formula, and formula for young children 

but also may include other CFSANregulated products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

New written requests to be placed on the lists ................... 370 1 370 1 370 

Third-party certification ........................................................ 370 1 370 21 7,770 

Biennial update .................................................................... 555 1 555 1 555 

Third-party certification biennial update ............................... 555 1 555 21 11,655 

Occasional updates ............................................................. 100 1 100 0.5 50 

Total .............................................................................. ........................ ........................ ........................ ........................ 20,400 

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

The burden for this information 

collection has not changed since the last 

OMB approval. Based on our experience 

maintaining other export lists, we 

estimate that, annually, an average of 

370 new manufacturers/processors will 

submit written requests to be placed on 

the China lists. The estimate of the 

number of hours that it will take a 


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43764 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

manufacturer/processor to gather the 

information needed to be placed on a 

list or update its information is based on 

FDA’s experience with manufacturers/ 

processors submitting similar requests. 

FDA believes that the information to be 

submitted will be readily available to 

manufacturers/processors. We estimate 

that a firm will require 1 hour to read 

the guidance, gather the information 

needed, and prepare a communication 

to FDA that contains the information 

needed to request that the 

manufacturer/processor be placed on a 

list. 

To be placed on a list, manufacturers/ 

processors should provide FDA with 

evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the 

manufacturer/processor complies with 

the standards, laws, and regulations of 

China according to relevant 

requirements specified in AQSIQ Decree 

145. Based on our experience with other 

certification programs, FDA estimates 

that it will take each new manufacturer/ 

processor about 21 hours to complete 

the third-party certification process for 

a total of 7,770 burden hours (370 

manufacturers/processors × 21 hours). 

Under the guidance, every 2 years 

each manufacturer/processor on the lists 

must provide updated information in 

order to remain on the lists. FDA 

estimates that each year approximately 

half of the manufacturers/processors on 

the lists, or 555 manufacturers/ 

processors (1,110 manufacturers/ 

processors × 0.5 = 555), will resubmit 

the information to remain on the lists. 

We estimate that a manufacturer/ 

processor already on the lists will 

require 1 hour to biennially update and 

resubmit the information to FDA, 

including time reviewing the 

information and corresponding with 

FDA, for a total of 555 hours. 

During the biennial update, 

manufacturers/processors also need to 

be recertified by a third-party certifier to 

remain on the lists. FDA estimates that 

each year approximately half of the 

manufacturers/processors on the lists, 

555 manufacturers/processors (1,110 

manufacturers/processors × 0.5 = 555), 

will get recertified. We estimate that it 

will take each manufacturer/processor 

about 21 hours to complete the 

certification process for a total of 11,655 

burden hours (555 manufacturers/ 

processors × 21 hours). 

FDA expects that, each year, 

approximately 100 manufacturers/ 

processors will need to submit an 

occasional update and each 

manufacturer/processor will require 0.5 

hours to prepare a communication to 

FDA reporting the change, for a total of 

50 hours. 

Dated: September 13, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19890 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0932] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study on Warning Statements for 

Cigarette Graphic Health Warnings 

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. 

DATES: Fax written comments on the 

collection of information by October 19, 

2017. 

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 ‘‘Experimental Study on Warning 

Statements for Cigarette Graphic Health 

Warnings.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonalynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A63, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Experimental Study on Warning 

Statements for Cigarette Graphic Health 

Warnings 

OMB Control Number 0910–NEW 

The health risks associated with the 

use of cigarettes can be significant and 

far-reaching. In 2009, Congress enacted 

the Tobacco Control Act (TCA) (Pub. L. 

111–31), which amends the Federal 

Food, Drug, and Cosmetic Act to grant 

FDA authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health and to reduce 

tobacco use by minors. Section 201 of 

the Tobacco Control Act amends section 

4 of the Federal Cigarette Labeling and 

Advertising Act (FCLAA) (15 U.S.C. 

1333) to require FDA to issue 

‘‘regulations that require color graphics 

depicting the negative health 

consequences of smoking to accompany 

the label statements specified in 

subsection (a)(1).’’ Section 202(b) of the 

Tobacco Control Act further amends 

section 4 of the FCLAA by adding that 

the Secretary, through notice and 

comment rulemaking, may adjust the 

‘‘text of any of the label requirements 

. . . . if the Secretary finds that such a 

change would promote greater public 

understanding of the risks associated 

with the use of tobacco products.’’ 

In the Federal Register of June 22, 

2011 (76 FR 36628), FDA issued a final 

rule entitled ‘‘Required Warnings for 

Cigarette Packages and 

Advertisements,’’ which specified nine 

images to accompany new textual 

warning statements for cigarettes. 

Although the rule was scheduled to 

become effective 15 months after it 

issued, a panel of the U.S. Court of 

Appeals of the District of Columbia 

held, on August 24, 2012, that the rule 

in its current form violated the First 

Amendment. In a letter to Congress on 

March 15, 2013, the Attorney General 

reported FDA’s intention to undertake 

research to support a new rulemaking 

consistent with the Tobacco Control 

Act. Preliminary research has been 

underway since 2013. Informed by the 

previous court decisions on this matter, 

including on the First Amendment, the 

next phase of the research includes the 

study proposed here, which is an effort 

by FDA to collect data concerning 

revised textual warning statements for 

use with new images as part of cigarette 

graphic health warnings, and their 

potential impact on public 

understanding of the risks associated 

with the use of cigarettes. 

As currently proposed, this 

Experimental Study on Warning 

Statements for Cigarette Graphic Health 

Warnings is a voluntary online 


asabaliauskas on DSKBBXCHB2PROD with NOTICES