Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68275 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

respondents 

Average burden 

per response Total hours 

203.30(a)(3), (a)(4), (c) Drug sample receipts ........ 61,961 12 743,532 .06 (4 minutes) .......... 44,612 

203.31(a)(1) and (b) Drug sample requests ............ 232,355 135 31,367,925 .04 (2 minutes) .......... 1,254,717 

203.31(a)(3), (a)(4),(c) Drug sample receipts .......... 232,355 135 31,367,925 .03 (2 minutes) .......... 941,038 

203.37(a) Falsification of records ............................ 50 4 200 .25 (15 minutes) ........ 50 

203.37(b) Loss or theft of samples .......................... 50 40 2000 .25 (15 minutes) ........ 500 

203.37(c) Convictions .............................................. 1 1 1 1 ................................ 1 

203.37(d) Contact person ........................................ 50 1 50 .08 (5 minutes) .......... 4 

203.39(g) Reconciliation report ................................ 1 1 1 1 ................................ 1 

Total .................................................................. ........................ ........................ ........................ .................................... 2,285,536 

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 Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per record-keeping Total hours 

203.23(a) and (b) Returned drugs ........................... 31,676 5 158,380 .25 (15 minutes) ........ 39,595 

203.23(c) Returned drugs documentation ............... 31,676 5 158,380 .08 (5 minutes) .......... 12,670 

203.30(a)(2) and 203.31(a)(2) Practitioner 

verification.

2,208 100 220,800 .50 (30 minutes) ........ 110,400 

203.31(d)(1) and (d)(2) Inventory record and reconciliation report.2,208 1 2,208 40 .............................. 88,320 

203.31(d)(4) Investigation of discrepancies and 

losses.

442 1 442 24 .............................. 10,608 

203.31(e) Representatives lists ............................... 2,208 1 2,208 1 ................................ 2,208 

203.34 Administrative systems ................................ 90 1 90 40 .............................. 3,600 

203.37(a) Falsification of drug sample records ....... 50 4 200 6 ................................ 1200 

203.37(b) Loss or theft of drug samples ................. 50 40 2000 6 ................................ 12,000 

203.39(d) Destroyed or returned drug samples ...... 65 1 65 1 ................................ 65 

203.39(e) Donated drug samples ............................ 3,221 1 3,221 .50 (30 minutes) ........ 1,611 

203.39(f) Distribution of donated drug samples ...... 3,221 1 3,221 8 ................................ 25,768 

203.39(g) Drug samples donated to charitable institutions.3,221 1 3,221 8 ................................ 25,768 

203.50(a) Drug origin statement .............................. 125 100 12,500 .17 (10 minutes) ........ 2,125 

203.50(b) Drug origin statement retention ............... 125 100 12,500 .50 (30 minutes) ........ 6,250 

203.50(d) Authorized distributors of record ............. 691 1 691 2 ................................ 1,382 

Total .................................................................. ........................ ........................ ........................ .................................... 343,570 

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

Dated: November 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26917 Filed 11–13–14; 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; Proposed Collection; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 procedure by which a manufacturer 

or distributor of a new dietary 

ingredient or of a dietary supplement 

containing a new dietary ingredient is to 

submit to FDA information upon which 

it has based its conclusion that a dietary 

supplement containing the new dietary 

ingredient will reasonably be expected 

to be safe. The notice also invites 

comments on two new forms FDA is 

developing to allow manufacturers and 

distributors to submit this information 

electronically via FDA’s Unified 

Registration and Listing System 

(FURLS). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

mstockstill on DSK4VPTVN1PROD with NOTICES

68276 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 

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: 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. 

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 FDA 

(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. FDA 

is 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. 

FDA is developing an electronic 

portal that interested persons will be 

able to use to electronically submit their 

notifications to ONLDS via 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 FDA’s safety 

review. Safety information will be 

submitted via a supplemental form 

entitled ‘‘New Dietary Ingredient 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. 

FDA estimates 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 capital costs or operating and maintenance costs associated with this collection of information. 

FDA believes that the burden of the 

premarket notification requirement on 

industry is limited and reasonable 

because FDA is 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68277 

with the FD&C Act. In the past, 

commenters have argued that FDA’s 

burden estimate is too low. FDA 

carefully considered the issue and 

believes that burden estimates of greater 

than 20 hours are likely to 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 

new dietary ingredient notifications, 

§ 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. FDA 

estimates 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, FDA seeks 

comments on this estimate. FDA 

encourages comments offering 

alternative burden estimates to include 

documentation to support the 

alternative estimate. 

FDA further estimates that 55 

respondents will submit 1 premarket 

notification each. FDA bases its estimate 

of the number of respondents on 

notifications received over the past 3 

years, which averaged about 55 

notifications per year. 

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26998 Filed 11–13–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0161] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 

information collection requirements 

imposed on firms that intend to export 

to countries that require an export 

certificate as a condition of entry for 

FDA regulated products, 

pharmaceuticals, biologics, and devices 

as indicated in the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) as 

amended. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: 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. 

Export of Food and Drug 

Administration Regulated Products: 

Export Certificates (OMB Control 

Number 0910–0498)—Extension 

In April 1996, a law entitled ‘‘The 

FDA Export Reform and Enhancement 

Act of 1996’’ (FDAERA) amended 

sections 801(e) and 802 of the FD&C Act 

(21 U.S.C. 381(e) and 382). It was 

designed to ease restrictions on 

exportation of unapproved 

pharmaceuticals, biologics, and devices 

regulated by FDA. Section 801(e)(4) of 

the FDAERA provides that persons 

exporting certain FDA regulated 

products may request FDA to certify 

that the products meet the requirements 

of 801(e) and 802 or other requirements 

of the FD&C Act. This section of the law 

requires FDA to issue certification 

within 20 days of receipt of the request 

and to charge firms up to $175 for the 

certifications. 

This section of the FD&C Act 

authorizes FDA to issue export 

certificates for regulated 

pharmaceuticals, biologics, and devices 

that are legally marketed in the United 

States, as well as for these same 

products that are not legally marketed 

but are acceptable to the importing 

country, as specified in sections 801(e) 

mstockstill on DSK4VPTVN1PROD with NOTICES