44422 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

We base our estimate on our review 

of the certification requests received 

over the past 3 fiscal years (FY). The 

annual burden estimate for this 

information collection is 3,536 hours. 

The estimated reporting burden for this 

information collection is 1,655 hours 

and the estimated recordkeeping burden 

for this information collection is 1,881 

hours. From FY 2014 to FY 2016, we 

processed an average of 7,524 responses 

(requests for certification of batches of 

color additives) per year. There were 38 

different respondents, corresponding to 

an average of approximately 198 

responses from each respondent per 

year. Using information from industry 

personnel, we estimate that an average 

of 0.22 hour per response is required for 

reporting (preparing certification 

requests and accompanying samples) 

and an average of 0.25 hour per 

response is required for recordkeeping. 

FDA’s web-based Color Certification 

information system allows submitters to 

request color certification online, follow 

their submissions through the process, 

and obtain information on account 

status. The system sends back the 

certification results electronically, 

allowing submitters to sell their 

certified color before receiving hardcopy 

certificates. Any delays in the system 

result only from shipment of color 

additive samples to FDA’s Office of 

Cosmetics and Colors for analysis. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20245 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0501] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Third Party 

Disclosure and Recordkeeping 

Requirements for Reportable Food 

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 23, 

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 0910–0643. 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. 

Third Party Disclosure and 

Recordkeeping Requirements for 

Reportable Food—21 U.S.C. 350f 

OMB Control Number 0910–0643— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Pub. L. 110–85), requires the 

establishment of a Reportable Food 

Registry (the Registry) by which 

instances of reportable food must be 

submitted to FDA by responsible parties 

and may be submitted by public health 

officials. Section 417 of the FD&C Act 

(21 U.S.C. 350f) defines ‘‘reportable 

food’’ as an ‘‘article of food (other than 

infant formula) for which there is a 

reasonable probability that the use of, or 

exposure to, such article of food will 

cause serious adverse health 

consequences or death to humans or 

animals.’’ (Section 417(a)(2) of the FD&C 

Act.) We believe that the most efficient 

and cost effective means to implement 

the Registry is by utilizing our 

electronic Safety Reporting Portal. The 

information collection provisions 

associated with the submission of 

reportable food reports has been 

approved under OMB control number 

0910–0643. 

In conjunction with the reportable 

foods requirements, section 417 of the 

FD&C Act also establishes third party 

disclosure and recordkeeping burdens. 

Specifically, we may require the 

responsible party to notify the 

immediate previous source(s) and/or 

immediate subsequent recipient(s) of a 

reportable food (section 417(d)(6)(B)(i) 

to (ii) of the FD&C Act). Similarly, we 

may also require the responsible party 

that is notified (i.e., the immediate 

previous source and/or immediate 

subsequent recipient) to notify their 

own immediate previous source(s) and/ 

or immediate subsequent recipient(s) of 

a reportable food (section 417(d)(7)(C)(i) 

to (ii) of the FD&C Act). 

Notification to the immediate 

previous source(s) and immediate 

subsequent recipient(s) of the article of 

food may be accomplished by electronic 

communication methods such as email, 

fax, or text messaging or by telegrams, 

mailgrams, or first-class letters. 

Notification may also be accomplished 

by telephone call or other personal 

contacts but we recommend that such 

notifications also be confirmed by one 

of the previous methods and/or 

documented in an appropriate manner. 

We may require that the notification 

include any or all of the following data 

elements: (1) The date on which the 

article of food was determined to be a 

reportable food; (2) a description of the 

article of food including the quantity or 

amount; (3) the extent and nature of the 

adulteration; (4) the results of any 

investigation of the cause of the 

adulteration if it may have originated 

with the responsible party, if known; (5) 

the disposition of the article of food, 

when known; (6) product information 

typically found on packaging including 

product codes, use-by dates, and the 

names of manufacturers, packers, or 

distributors sufficient to identify the 

article of food; (7) contact information 

for the responsible party; (8) contact 

information for parties directly linked in 

the supply chain and notified under 

section 417(d)(6)(B) or 417(d)(7)(C) of 

the FD&C Act, as applicable; (9) the 

information required by FDA to be 

included in the notification provided by 

the responsible party involved under 

section 417(d)(6)(B) or 417(d)(7)(C) of 

the FD&C Act or required to report 

under section 417(d)(7)(A) of the FD&C 

Act; and (10) the unique number 

described in section 417(d)(4) of the 

FD&C Act (section 417(d)(6)(B)(iii)(I), 

(d)(7)(C)(iii)(I), and (e) of the FD&C Act). 

We may also require that the 

notification provides information about 

the actions that the recipient of the 

notification will perform and/or any 

other information we may require 

(section 417(d)(6)(B)(iii)(II) and (III), 

(d)(7)(C)(iii)(II) and (III) of the FD&C 

Act). 

Section 417(g) of the FD&C Act 

requires that responsible persons 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44423 

maintain records related to reportable 

foods for a period of 2 years. 

The congressionally identified 

purpose of the Registry is to provide ‘‘a 

reliable mechanism to track patterns of 

adulteration in food [which] would 

support efforts by the Food and Drug 

Administration to target limited 

inspection resources to protect the 

public health’’ (FDAAA, section 

1005(a)(4)). The reporting and 

recordkeeping requirements described 

previously are designed to enable FDA 

to quickly identify and track an article 

of food (other than infant formula) for 

which there is a reasonable probability 

that the use of or exposure to such 

article of food will cause serious adverse 

health consequences or death to humans 

or animals. We use the information 

collected under these provisions to help 

ensure that such products are quickly 

and efficiently removed from the 

market. 

As required under section 1005(f) of 

FDAAA and to assist industry, we have 

issued the guidance document entitled, 

‘‘Questions and Answers Regarding the 

Reportable Food Registry as Established 

by the Food and Drug Administration 

Amendments Act of 2007,’’ which is 

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

GuidanceRegulation/Guidance

DocumentsRegulatoryInformation/

ucm180761.htm. The guidance contains 

questions and answers relating to the 

requirements under section 417 of the 

FD&C Act, including: (1) How, when, 

and where to submit reports to FDA; (2) 

who is required to submit reports to 

FDA; (3) what is required to be 

submitted to FDA; and (4) what may be 

required when providing notifications 

to other persons in the supply chain of 

an article of food. The guidance also 

refers to previously approved 

collections of information found in FDA 

regulations. The collections of 

information in questions 20 and 21 of 

the guidance have been approved under 

OMB control number 0910–0249. 

Description of Respondents: 

Mandatory respondents to this 

collection of information are the 

owners, operators, or agents in charge of 

a domestic or foreign facility engaged in 

manufacturing, processing, packing, or 

holding food for consumption in the 

United States (‘‘responsible parties’’) 

who have information on a reportable 

food. Voluntary respondents to this 

collection of information are Federal, 

State, and local public health officials 

who have information on a reportable 

food. 

In the Federal Register of June 7, 2017 

(82 FR 26489), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Notifying immediate previous source of the article 

of food under section 417(d)(6)(B)(i) of the 

FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) .......... 720 

Notifying immediate subsequent recipient of the 

article of food under section 417(d)(6)(B)(ii) of 

the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) .......... 720 

Notifying immediate previous source of the article 

of food under section 417(d)(7)(C)(i) of the 

FD&C Act (mandatory reporters only).

1 1,200 0.6 (36 

minutes) 

720.

Notifying immediate subsequent recipient of the 

article of food under section 417(d)(7)(C)(ii) of 

the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) .......... 720 

Total ................................................................ ........................ ........................ ........................ ..................................... 2,880 

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

Third Party Disclosure: We estimate 

that approximately 1,200 reportable 

food events with mandatory reporters 

will occur annually. Based on past FDA 

experiences, we estimate that we could 

receive 200 to 1,200 ‘‘reportable’’ food 

reports annually from 200 to 1,200 

mandatory and voluntary users of the 

electronic reporting system. We utilized 

the upper-bound estimate of 1,200 for 

these calculations. 

We estimate that notifying the 

immediate previous source(s) will take 

0.6 hours per reportable food and 

notifying the immediate subsequent 

recipient(s) will take 0.6 hours per 

reportable food. We also estimate that it 

will take 0.6 hours for the immediate 

previous source and/or the immediate 

subsequent recipient to also notify their 

immediate previous source(s) and/or 

immediate subsequent recipient(s). The 

Agency bases its estimate on its 

experience with mandatory and 

voluntary reports submitted to FDA. 

Although it is not mandatory under 

FDAAA, section 1005, that responsible 

persons notify the sources and 

recipients of instances of reportable 

food, for purposes of the burden 

estimate we are assuming FDA would 

exercise its authority and require such 

notifications in all such instances for 

mandatory reporters. This notification 

burden will not affect voluntary 

reporters of reportable food events. 

Therefore, we estimate that the total 

burden of notifying the immediate 

previous source(s) and immediate 

subsequent recipient(s) under section 

417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and 

(ii) of the FD&C Act for 1,200 reportable 

foods will be 2,880 hours annually 

(1,200 × 0.6 hours) + (1,200 × 0.6 hours) 

+ (1,200 × 0.6 hours) + (1,200 × 0.6 

hours). This annual burden is shown in 

table 1. 

44424 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Maintenance of reportable food records under 

section 417(g) of the FD&C Act—mandatory reports.

1,200 1 1,200 0.25 (15 minutes) ........ 300 

Maintenance of reportable food records under 

section 417(g) of the FD&C Act—voluntary reports.

4 1 4 0.25 (15 minutes) ........ 1 

Total ................................................................ ........................ ........................ ........................ ..................................... 301 

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

Recordkeeping: As noted previously, 

section 417(g) of the FD&C Act requires 

that responsible persons maintain 

records related to reportable foods 

reports and notifications under section 

417 of the FD&C Act for a period of 2 

years. Based on past FDA experiences, 

we estimate that each mandatory report 

and its associated notifications will 

require 30 minutes of recordkeeping for 

the 2-year period, or 15 minutes per 

record per year. The annual 

recordkeeping burden for mandatory 

reportable food reports and their 

associated notifications is thus 

estimated to be 300 hours (1,200 × 0.25 

hours). 

We do not expect that records will 

always be kept in relation to voluntary 

reportable food reports. Therefore, we 

estimate that records will be kept for 

four voluntary reports we expect to 

receive annually. The recordkeeping 

burden associated with voluntary 

reports is thus estimated to be 1 hour 

annually (4 × 0.25 hours). The estimated 

total annual recordkeeping burden will 

be 301 hours annually (1,200 × 0.25 

hours) + (4 × 0.25 hours). This annual 

burden is shown in table 2. 

Dated: September 19, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–20283 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0019] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Customer/Partner 

Service Surveys 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 23, 

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 0910–0360. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Customer/Partner Service Surveys 

OMB Control Number 0910–0360— 

Extension 

Under section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393), FDA is authorized to conduct 

research and public information 

programs about regulated products and 

responsibilities of the Agency. 

Executive Order 12862, entitled, 

‘‘Setting Customer Service Standard,’’ 

directs Federal Agencies that ‘‘provide 

significant services directly to the 

public’’ to ‘‘survey customers to 

determine the kind and quality of 

services they want and their level of 

satisfaction with existing services.’’ FDA 

is seeking OMB clearance to conduct a 

series of surveys to implement 

Executive Order 12862. Participation in 

the surveys is voluntary. This request 

covers customer/partner service surveys 

of regulated entities, such as food 

processors; cosmetic drug, biologic and 

medical device manufacturers; 

consumers; and health professionals. 

The request also covers ‘‘partner’’ (State 

and local governments) customer 

service surveys. 

FDA will use the information from 

these surveys to identify strengths and 

weaknesses in service to customers/ 

partners and to make improvements. 

The surveys will measure timeliness, 

appropriateness and accuracy of 

information, and courtesy and problem 

resolution in the context of individual 

programs. 

FDA estimates conducting 15 

customer/partner service surveys per 

year, each requiring an average of 15 

minutes for review and completion. We 

estimate respondents to these surveys to 

be between 100 and 20,000 customers. 

Some of these surveys will be repeats of 

earlier surveys for purposes of 

monitoring customer/partner service 

and developing long-term data. 

In the Federal Register of June 7, 2017 

(82 FR 26497), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

FDA estimates the burden of this 

collection of information as follows: