44420 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

on average would be needed per 

response for certifications which 

accompany NDA, BLA, PMA, HDE, 

510(k), and ANDA marketing 

applications and submissions. It is 

assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center activity 

Number of 

respondents 

(investigational 

applications) 

Number of 

respondents 

(marketing 

applications) 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER 

New Applications (IND) ................ 1,669 ........................ 1 1,669 0.25 (15 minutes) .. 417 

Clinical Protocol Amendments 

(IND).

15,285 ........................ 1 15,285 0.25 (15 minutes) .. 3,821 

New Marketing Applications/Resubmissions (NDA/BLA)............................. 198 1 198 0.75 (45 minutes) .. 149 

Clinical Amendments to Marketing 

Applications.

............................ 1,067 1 1,067 0.75 (45 minutes) .. 800 

Efficacy Supplements/Resubmissions............................. 219 1 219 0.75 (45 minutes) .. 164 

CBER 

New Applications (IND) ................ 381 ........................ 1 381 0.25 (15 minutes) .. 95 

Clinical Protocol Amendments 

(IND).

456 ........................ 1 456 0.25 (15 minutes) .. 114 

New Marketing Applications/Resubmissions (NDA/BLA)............................. 54 1 54 0.75 (45 minutes) .. 41 

Clinical Amendments to Marketing 

Applications.

............................ 0 1 0 0.75 (45 minutes) .. 0 

Efficacy Supplements/Resubmissions (BLA only)............................. 34 1 34 0.75 (45 minutes) .. 26 

CDRH 

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to 

contain clinical data).

............................ 330 1 330 0.75 (45 minutes) .. 247 

OGD 

Original Applications ..................... ............................ 1,036 1 ........................ 0.75 (45 minutes) .. 777 

Bioequivalence Supplements/ 

Amendments.

............................ 698 1 ........................ 0.75 (45 minutes) .. 524 

Total ...................................... ............................ ........................ ........................ ........................ ............................... 7,175 

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

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20227 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–2010–N–0622] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Color Additive 

Certification Requests and 

Recordkeeping 

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 0910–0216. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44421 

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. 

Color Additive Certification Requests 

and Recordkeeping—21 CFR Part 80 

OMB Control Number 0910–0216— 

Extension 

We have regulatory oversight for color 

additives used in foods, drugs, 

cosmetics, and medical devices. Section 

721(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379e(a)) 

provides that a color additive shall be 

deemed to be unsafe unless it meets the 

requirements of a listing regulation, 

including any requirement for batch 

certification, and is used in accordance 

with the regulation. We list color 

additives that have been shown to be 

safe for their intended uses in Title 21 

of the Code of Federal Regulations 

(CFR). We require batch certification for 

all color additives listed in 21 CFR part 

74 and for all color additives 

provisionally listed in 21 CFR part 82. 

Color additives listed in 21 CFR part 73 

are exempted from certification. 

The requirements for color additive 

certification are described in 21 CFR 

part 80. In the certification procedure, a 

representative sample of a new batch of 

color additive, accompanied by a 

‘‘request for certification’’ that provides 

information about the batch, must be 

submitted to FDA’s Office of Cosmetics 

and Colors. FDA personnel perform 

chemical and other analyses of the 

representative sample and, providing 

the sample satisfies all certification 

requirements, issue a certification lot 

number for the batch. We charge a fee 

for certification based on the batch 

weight and require manufacturers to 

keep records of the batch pending and 

after certification. 

Under § 80.21, a request for 

certification must include: Name of 

color additive, manufacturer’s batch 

number and weight in pounds, name 

and address of manufacturer, storage 

conditions, statement of use(s), 

certification fee, and signature of person 

requesting certification. Under § 80.22, a 

request for certification must include a 

sample of the batch of color additive 

that is the subject of the request. The 

sample must be labeled to show: Name 

of color additive, manufacturer’s batch 

number and quantity, and name and 

address of person requesting 

certification. Under § 80.39, the person 

to whom a certificate is issued must 

keep complete records showing the 

disposal of all of the color additive 

covered by the certificate. Such records 

are to be made available upon request to 

any accredited representative of FDA 

until at least 2 years after disposal of all 

of the color additive. 

The purpose for collecting this 

information is to help us assure that 

only safe color additives will be used in 

foods, drugs, cosmetics, and medical 

devices sold in the United States. The 

required information is unique to the 

batch of color additive that is the subject 

of a request for certification. The 

manufacturer’s batch number is used for 

temporarily identifying a batch of color 

additive until FDA issues a certification 

lot number and for identifying a 

certified batch during inspections. The 

manufacturer’s batch number also aids 

in tracing the disposal of a certified 

batch or a batch that has been denied 

certification for noncompliance with the 

color additive regulations. The 

manufacturer’s batch weight is used for 

assessing the certification fee. The batch 

weight also is used to account for the 

disposal of a batch of certified or 

certification-denied color additive. The 

batch weight can be used in a recall to 

determine whether all unused color 

additive in the batch has been recalled. 

The manufacturer’s name and address 

and the name and address of the person 

requesting certification are used to 

contact the person responsible should a 

question arise concerning compliance 

with the color additive regulations. 

Information on storage conditions 

pending certification is used to evaluate 

whether a batch of certified color 

additive is inadvertently or 

intentionally altered in a manner that 

would make the sample submitted for 

certification analysis unrepresentative 

of the batch. We check storage 

information during inspections. 

Information on intended uses for a batch 

of color additive is used to assure that 

a batch of certified color additive will be 

used in accordance with the 

requirements of its listing regulation. 

The statement of the fee on a 

certification request is used for 

accounting purposes so that a person 

requesting certification can be notified 

promptly of any discrepancies. 

In the Federal Register of June 14, 

2017 (82 FR 27259), 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 REPORTING BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

80.21; Request for Certification ............................... 38 198 7,524 0.17 (10 minutes) ...... 1,279 

80.22; Sample to Accompany Request ................... 38 198 7,524 0.05 (3 minutes) ........ 376 

Total .................................................................. ........................ ........................ ........................ 0.22 (13 minutes) ...... 1,655 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section/activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

80.39; Record of Distribution ................................. 38 198 7,524 .25 (15 minutes) .......... 1,881 

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

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