Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10121 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR Section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Total .................................. ............................ .............................. ............................ .................................................. 882,203 

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

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03881 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0878] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by March 27, 

2015. 

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 0910–0330. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE—14526, Silver 

Spring, MD 20993–0002, 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. 

Premarket Notification for a New 

Dietary Ingredient—21 CFR 190.6 

(OMB Control Number 0910–0330)— 

Extension 

Section 413(a) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350b(a)) provides that at least 

75 days before the introduction or 

delivery for introduction into interstate 

commerce of a dietary supplement that 

contains a new dietary ingredient, the 

manufacturer or distributor of the 

dietary supplement or of the new 

dietary ingredient is to submit to us (as 

delegate for the Secretary of Health and 

Human Services) information upon 

which the manufacturer or distributor 

has based its conclusion that a dietary 

supplement containing the new dietary 

ingredient will reasonably be expected 

to be safe. FDA’s implementing 

regulation, 21 CFR 190.6, requires this 

information to be submitted to the 

Office of Nutrition, Labeling, and 

Dietary Supplements (ONLDS) in the 

form of a notification. Under § 190.6(b), 

the notification must include the 

following: (1) The name and complete 

address of the manufacturer or 

distributor, (2) the name of the new 

dietary ingredient, (3) a description of 

the dietary supplement(s) that contain 

the new dietary ingredient, including 

the level of the new dietary ingredient 

in the dietary supplement and the 

dietary supplement’s conditions of use, 

(4) the history of use or other evidence 

of safety establishing that the new 

dietary ingredient will reasonably be 

expected to be safe when used under the 

conditions recommended or suggested 

in the labeling of the dietary 

supplement, and (5) the signature of a 

responsible person designated by the 

manufacturer or distributor. 

These premarket notification 

requirements are designed to enable us 

to monitor the introduction into the 

marketplace of new dietary ingredients 

and dietary supplements that contain 

new dietary ingredients, in order to 

protect consumers from ingredients and 

products whose safety is unknown. We 

use the information collected in new 

dietary ingredient notifications to 

evaluate the safety of new dietary 

ingredients in dietary supplements and 

to support regulatory action against 

ingredients and products that are 

potentially unsafe. 

We are developing an electronic 

portal that interested persons will be 

able to use to electronically submit their 

notifications to ONLDS via FDA Unified 

Registration and Listing System 

(FURLS). Firms that prefer to submit a 

paper notification in a format of their 

own choosing will still have the option 

to do so, however. Form FDA 3880 

prompts a submitter to input the 

elements of a new dietary ingredient 

notification (NDIN) in a standard format 

and helps the submitter organize its 

NDIN to focus on the information 

needed for our safety review. Safety 

information will be submitted via a 

supplemental form entitled ‘‘New 

Dietary Ingredient (NDI) Safety 

Information.’’ This form provides a 

standard format to describe the history 

of use or other evidence of safety on 

which the manufacturer or distributor 

bases its conclusion that the new dietary 

ingredient will be reasonably expected 

to be safe under the conditions of use 

recommended or suggested in the 

labeling of the dietary supplement, as 

well as related identity information that 

is necessary to demonstrate safety by 

showing that the new dietary ingredient 

and dietary supplement(s) that are the 

subject of the notification are the same 

or similar to the ingredients and 

products for which safety data and 

information have been provided. Draft 

screenshots of Form FDA 3880 and the 

supplemental safety information form 

are available for comment at http://

www.fda.gov/Food/Dietary

Supplements/NewDietaryIngredients

NotificationProcess/ucm356620.htm. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers and 

distributors in the dietary supplement 

industry; specifically, firms that 

manufacture or distribute new dietary 

ingredients or dietary supplements that 

contain a new dietary ingredient. 

In the Federal Register of November 

14, 2014 (79 FR 68275), we published a 

60-day notice requesting public 

comment on the proposed extension of 

this collection of information. We 

received three comments in response to 

the notice. Two of the comments were 

unrelated to the PRA, and therefore we 

did not consider them. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
10122 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

The third comment asserted that we 

underestimated the reporting burden of 

the NDIN procedures under § 190.6 by 

failing to take into account the 

recommendations in the draft guidance 

entitled ‘‘Dietary Supplements: New 

Dietary Ingredient Notifications and 

Related Issues’’ (the 2011 draft 

guidance) (available at http://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/

DietarySupplements/ucm257563.htm). 

FDA announced the availability of the 

2011 draft guidance for comment in a 

notice published in the Federal Register 

of July 5, 2011 (76 FR 39111). 

Although we agree with the 

commenter that information collection 

recommendations in guidance are 

subject to the PRA, we intend to meet 

our PRA obligations in that regard 

separately at a later time. The 2011 draft 

guidance was published solely for the 

purpose of seeking comment, and it has 

not been made final. Moreover, FDA 

intends to publish a revised draft 

guidance for comment later this year, 

and the revised draft guidance will 

supersede the 2011 draft guidance. 

Although we expect the revised draft 

guidance to be followed by a final 

guidance, there will be an interim 

period where no guidance on NDINs is 

in effect. The purpose of the current 

PRA proceeding is to seek comment on 

and obtain OMB approval for the NDIN 

collections of information in effect 

during this interim period, which are 

those found in the FDA’s NDIN 

regulations at § 190.6 and in the 

electronic NDIN submission forms that 

we have made available for comment. 

After publishing a revised draft 

guidance on NDINs and related issues, 

we intend to publish a 60-day notice 

inviting comment on the proposed 

collections of information associated 

with that document. At that time, we 

will carefully evaluate all comments we 

receive. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

190.6 .................................................................................... 55 1 55 20 1,100 

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

We believe that the burden of the 

premarket notification requirement on 

industry is limited and reasonable 

because we are requesting only safety 

and identity information that the 

manufacturer or distributor should 

already have developed to satisfy itself 

that a dietary supplement containing a 

new dietary ingredient is in compliance 

with the FD&C Act. In the past, 

commenters have argued that our 

burden estimate is too low. We carefully 

considered the issue and believe that 

burden estimates of greater than 20 

hours per notification likely include the 

burden associated with researching and 

generating safety data for a new dietary 

ingredient. Under section 413(a)(2) of 

the FD&C Act, a dietary supplement that 

contains a new dietary ingredient is 

deemed to be adulterated unless there is 

a history of use or other evidence of 

safety establishing that the new dietary 

ingredient will reasonably be expected 

to be safe under the conditions of use 

recommended or suggested in the 

labeling of the dietary supplement. This 

requirement is separate from and 

additional to the requirement to submit 

a premarket notification for the new 

dietary ingredient. FDA’s regulation on 

NDINs, § 190.6(a), requires the 

manufacturer or distributor of the 

dietary supplement, or of the new 

dietary ingredient, to submit to FDA the 

information that forms the basis for its 

conclusion that a dietary supplement 

containing the new dietary ingredient 

will reasonably be expected to be safe. 

Thus, § 190.6 only requires the 

manufacturer or distributor to extract 

and summarize information that should 

have already been developed to meet 

the safety requirement in section 

413(a)(2) of the FD&C Act. We estimate 

that extracting and summarizing the 

relevant information from what exists in 

the company’s files and presenting it in 

a format that meets the requirements of 

§ 190.6 will take approximately 20 

hours of work per notification. 

However, we seek comments on this 

estimate. We encourage comments 

offering alternative burden estimates to 

include documentation to support the 

alternative estimate. 

We further estimate that 55 

respondents will submit 1 premarket 

notification each. We base our estimate 

of the number of respondents on 

notifications received over the past 3 

years, which averaged about 55 

notifications per year. 

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03833 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0230] 

Technical Performance Assessment of 

Digital Pathology Whole Slide Imaging 

Devices; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Technical Performance Assessment of 

Digital Pathology Whole Slide Imaging 

Devices.’’ This draft guidance provides 

industry and Agency staff with 

recommendations regarding the 

technical performance assessment data 

that should be provided for regulatory 

evaluation of a digital whole slide 

imaging (WSI) system. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 26, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 


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