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recommendations in the draft guidance 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2011 draft guidance for comment in a 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and the revised draft guidance will 

supersede the 2011 draft guidance.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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10123 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Technical 

Performance Assessment of Digital 

Pathology Whole Slide Imaging 

Devices’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Anderson, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5570, Silver Spring, 

MD 20993–0002, 301–796–4310; or 

Aldo Badano, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 3116, Silver Spring, 

MD 20993–0002, 301–796–2534. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Recent technological advances in 

digital microscopy, in particular the 

development of whole slide scanning 

systems, have accelerated the adoption 

of digital imaging in pathology, similar 

to the digital transformation that 

radiology departments have experienced 

over the last decade. FDA regulates WSI 

systems manufacturers to ensure that 

the images produced for clinical 

intended uses are safe and effective for 

such purposes. Essential to the 

regulation of these systems is the 

understanding of the technical 

performance of the components in the 

imaging chain, from image acquisition 

to image display and their effect on 

pathologist’s diagnostic performance 

and workflow. 

This draft guidance provides industry 

and Agency staff with recommendations 

regarding the technical performance 

assessment data that should be included 

for regulatory evaluation of a WSI. This 

document does not cover the clinical 

submission data that may be necessary 

to support approval or clearance. The 

guidance provides our suggestions on 

how to best characterize the technical 

aspects that are relevant to WSI 

performance for their intended use and 

determine any possible limitations that 

might affect their safety and 

effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on technical performance assessment of 

digital pathology WSI devices. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Technical Performance Assessment 

of Digital Pathology Whole Slide 

Imaging Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1400053 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120, 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231, and 

the collections of information in 21 CFR 

part 801 and 21 CFR 809.10 have been 

approved under OMB control number 

0910–0485. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03843 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–N–0001] 

Pediatric Ethics Subcommittee of the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency 

regarding ethical protections for 

children in FDA-regulated clinical 

trials. 

Date and Time: The meeting will be 

held on Monday, March 23, 2015 from 

8:30 a.m. to 4:30 p.m. 

Location: Doubletree by Hilton Hotel, 

8727 Colesville Rd., Silver Spring, MD 

20910. Answers to commonly asked 

questions, including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation, may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Walter Ellenberg, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5154, 

Silver Spring, MD 20993, 301–796– 

0885, email walter.ellenberg@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 


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