70876 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 

from 3,000 adult members in online 

consumer panels maintained by a 

contractor. The study plans to randomly 

select 800 panel members in each of 

three groups: Spanish-dominant 

Hispanics, English-dominant Hispanics, 

and English-speaking non-Hispanics. 

Both English and Spanish 

questionnaires will be used, as 

appropriate. The study plans to include 

topics such as: (1) Food safety 

knowledge and attitude and (2) food 

handling and consumption practice. To 

help us understand the data, the study 

will also collect information on 

respondents’ background, including, but 

not limited to, health status and 

demographic characteristics, such as 

age, gender, education, and income, and 

degree of acculturation among Hispanic 

respondents using a measure developed 

by Marin, et al. (Ref. 6). 

The study is part of our continuing 

effort to protect the public health. We 

will not use the results of the study to 

develop population estimates. We will 

use the results of the study to develop 

followup quantitative and qualitative 

research to gauge the prevalence and 

extent of differences in food safety 

knowledge and behaviors between the 

three mentioned population groups. We 

will use the results of the followup 

research to help inform the design of 

effective education and outreach 

initiatives aimed at helping reduce the 

risk of foodborne illness for the general 

U.S. population as well as Hispanics. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Cognitive interview screener ............. 72 1 72 0.083 (5 minutes) ............................. 6 

Cognitive interview ............................ 9 1 9 0.5 (30 minutes) ............................... 5 

Pretest invitation ............................... 1,440 1 1,440 0.033 (2 minutes) ............................. 48 

Pretest ............................................... 180 1 180 0.25 (15 minutes) ............................. 45 

Study invitation .................................. 24,000 1 24,000 0.033 (2 minutes) ............................. 792 

Study ................................................. 3,000 1 3,000 0.25 (15 minutes) ............................. 750 

Total ........................................... ........................ ........................ ........................ ........................................................... 1,646 

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

We base our estimates on prior 

experience with research that is similar 

to this proposed study. We will use a 

cognitive interview screener with 72 

individuals to recruit prospective 

interview participants. We estimate that 

it will take a screener respondent 

approximately 5 minutes (0.083 hours) 

to complete the cognitive interview 

screener, for a total of 5.976 hours, 

rounded to 6 hours. We will conduct 

cognitive interviews with nine 

participants. We estimate that it will 

take a participant approximately 30 

minutes to complete the interview, for 

a total of 4.5 hours, rounded to 5 hours. 

We also plan to conduct a pretest to 

identify and resolve potential survey 

administration problems. We will send 

a pretest invitation to 1,440 prospective 

pretest participants and estimate that it 

will take a respondent approximately 2 

minutes (0.033 hours) to complete the 

invitation, for a total of 47.52 hours, 

rounded to 48 hours. We will 

administer the pretest with 180 

participants and estimate that it will 

take a participant 15 minutes (0.25 

hours) to complete the pretest, for a total 

of 45 hours. We will send a study 

invitation to 24,000 prospective 

participants and estimate that it will 

take a respondent approximately 2 

minutes (0.033 hours) to complete the 

invitation, for a total of 792 hours. We 

will administer the study with 3,000 

participants and estimate that it will 

take a participant 15 minutes (0.25 

hours) to complete the study, for a total 

of 750 hours. The total estimated burden 

for all the study activities is 1,646 

hours. 

II. References 

1. FDA. ‘‘Foodborne Illness & Contaminants.’’ 

June 9, 2014. Available at http://

www.fda.gov/Food/

FoodborneIllnessContaminants/

default.htm. 

2. Passel, J. S. and D’V. Cohn. ‘‘U.S. 

Population Projections: 2005–2050.’’ 

Pew Research Center. Washington, DC 

February 11, 2008. Available at http://

pewhispanic.org/files/reports/85.pdf. 

3. Quinlan, J. J. ‘‘Foodborne Illness Incidence 

Rates and Food Safety Risks for 

Populations of Low Socioeconomic 

Status and Minority Race/Ethnicity: A 

Review of the Literature.’’ International 

Journal of Environmental Research and 

Public Health, 10(8): 3634–3652. 2013. 

4. Taylor, P., M. H. Lopez, J. Martı ́nez, and 

G. Velasco. ‘‘Language Use Among 

Latinos.’’ Pew Research Center. 

Washington, DC April 4, 2012. Available 

at http://www.pewhispanic.org/2012/04/

04/iv-language-use-among-latinos/. 

5. Henley, S. C., S. E. Stein, and J. J. Quinlan. 

‘‘Identification of Unique Food Handling 

Practices That Could Represent Food 

Safety Risks for Minority Consumers.’’ 

Journal of Food Protection, 75: 2050– 

2054. 2012. 

6. Marin, G., F. Sabogal, B. V. Marin, et al. 

‘‘Development of a Short Acculturation 

Scale for Hispanics.’’ Hispanic Journal of 

Behavioral Sciences, 9(2): 183–205. 

1987. 

Dated: November 21, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28088 Filed 11–26–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1152] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Petition To 

Request an Exemption From 100 

Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 70877 

DATES: Fax written comments on the 

collection of information by December 

29, 2014. 

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 0910–0608. 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. 

Petition to Request an Exemption 

from 100 Percent Identity Testing of 

Dietary Ingredients: 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements—21 CFR 111.75(a)(1)(ii) 

(OMB Control Number 0910–0608)— 

Reinstatement 

The Dietary Supplement Health and 

Education Act (DSHEA) (Pub. L. 103– 

417) added section 402(g) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 342(g)), which provides, 

in part, that the Secretary of Health and 

Human Services (the Secretary) may, by 

regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g)(1) of the 

FD&C Act states that a dietary 

supplement is adulterated if ‘‘it has 

been prepared, packed, or held under 

conditions that do not meet current 

good manufacturing practice 

regulations.’’ Section 701(a) of the FD&C 

Act (21 U.S.C. 371(a)) gives us the 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

Part 111 of our regulations (21 CFR 

part 111) establishes the minimum 

current good manufacturing practice 

(CGMP) necessary for activities related 

to manufacturing, packaging, labeling, 

or holding dietary supplements to 

ensure the quality of the dietary 

supplement. Section 111.75(a)(1) of our 

regulations establishes a procedure for a 

petition to request an exemption from 

100 percent identity testing of dietary 

ingredients. In accordance with 

§ 111.75(a)(1)(ii), manufacturers may 

request an exemption from the 

requirements set forth in 

§ 111.75(a)(1)(i) when the dietary 

ingredient is obtained from one or more 

suppliers identified in the petition. The 

regulation clarifies that we are willing to 

consider, on a case-by-case basis, a 

manufacturer’s conclusion, supported 

by appropriate data and information in 

the petition submission, that it has 

developed a system that it would 

implement as a sound, consistent means 

of establishing, with no material 

diminution of assurance compared to 

the assurance provided by 100 percent 

identity testing, the identity of the 

dietary ingredient before use. 

Section 111.75(a)(1) reflects our 

determination that manufacturers that 

test or examine 100 percent of the 

incoming dietary ingredients for 

identity can be assured of the identity 

of the ingredient. However, we 

recognize that it may be possible for a 

manufacturer to demonstrate, through 

various methods and processes in use 

over time for its particular operation, 

that a system of less than 100 percent 

identity testing would result in no 

material diminution of assurance of the 

identity of the dietary ingredient as 

compared to the assurance provided by 

100 percent identity testing. To provide 

an opportunity for a manufacturer to 

make such a showing and reduce the 

frequency of identity testing of 

components that are dietary ingredients 

from 100 percent to some lower 

frequency, we added to § 111.75(a)(1), 

an exemption from the requirement of 

100 percent identity testing when a 

manufacturer petitions the Agency for 

such an exemption to 100 percent 

identity testing under § 10.30 and the 

Agency grants such exemption. Such a 

procedure would be consistent with our 

stated goal, as described in the CGMP 

final rule, of providing flexibility in the 

CGMP requirements. Section 

111.75(a)(1)(ii) sets forth the 

information a manufacturer is required 

to submit in such a petition. The 

regulation also contains a requirement 

to ensure that the manufacturer keeps 

our response to a petition submitted 

under § 111.75(a)(1)(ii) as a record 

under § 111.95. The collection of 

information in § 111.95 has been 

approved under OMB control number 

0910–0606. 

Description of Respondents: The 

respondents to this collection of 

information are firms in the dietary 

supplement industry, including dietary 

supplement manufacturers, packagers 

and re-packagers, holders, labelers and 

re-labelers, distributors, warehouses, 

exporters, importers, large businesses, 

and small businesses. 

In the Federal Register of November 

14, 2013 (78 FR 68453), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. While three comments 

were received, none were responsive to 

the four collection of information topics 

solicited in the notice and therefore are 

not discussed in this document. 

Additionally, although FDA was unable 

to publish a 30 day notice before the 

information collection expiration and is 

therefore requesting its reinstatement, 

the Agency has not conducted or 

sponsored any collection of information 

under OMB control number 0910–0608 

in the interim period. 

We estimate the annual burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; CGMP requirements for dietary 

supplements 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

111.75(a)(1)(ii) ..................................................................... 1 1 1 8 8 

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

In the last 3 years, we have not 

received any new petitions to request an 

exemption from 100 percent identity 

testing of dietary ingredients; therefore, 

the Agency estimates that one or fewer 

petitions will be submitted annually. 

Based on our experience with petition 

processes, we estimate it will take a 

requestor about 8 hours to prepare the 

factual and legal information necessary 

to support a petition for exemption and 

to prepare the petition. Although we 

have not received any new petitions to 

request an exemption from 100 percent 

identity testing of dietary ingredients in 


tkelley on DSK3SPTVN1PROD with NOTICES
70878 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 

the last 3 years, we believe that OMB 

approval of these information collection 

provisions should be extended to 

provide for the potential future need of 

a firm in the dietary supplement 

industry to petition for an exemption 

from 100 percent identity testing of 

dietary ingredients. 

Dated: November 21, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28087 Filed 11–26–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1981] 

The Drug Supply Chain Security Act 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs: How To Exchange Product 

Tracing Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs: 

How To Exchange Product Tracing 

Information.’’ The draft guidance 

addresses the drug supply chain 

security provisions of the Federal Food, 

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

which requires the Secretary of the 

Department of Health and Human 

Services to establish initial standards for 

the interoperable exchange of 

transaction information, transaction 

history, and transaction statements, in 

paper or electronic format. Specifically, 

the guidance establishes standards for 

how transaction information, 

transaction history, and transaction 

statements should be exchanged among 

trading partners through the extension 

and/or use of current systems and 

processes. 

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 on 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 January 27, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the draft guidance by January 27, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993; or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Office of Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100, 

drugtrackandtrace@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On November 27, 2013, the Drug 

Supply Chain Security Act (Title II of 

Public Law 113–54) was signed into 

law. Section 202 of the Drug Supply 

Chain Security Act (DSCSA), which 

adds new sections 581 and 582 to the 

FD&C Act (21 U.S.C. 360eee and 

360eee–1), sets forth new definitions 

and requirements related to product 

tracing. The DSCSA outlines critical 

steps to build an electronic, 

interoperable system by November 27, 

2023, that will identify and trace certain 

prescription drugs as they are 

distributed within the United States. 

Starting in 2015, certain trading 

partners (manufacturers, wholesale 

distributors, dispensers, and 

repackagers) are required under sections 

582(b)(1), (c)(1), (d)(1), and (e)(1) of the 

FD&C Act to capture, maintain, and 

provide the subsequent purchaser with 

transaction information, transaction 

history, and a transaction statement 

(product tracing information) for certain 

prescription drug products. 

Manufacturers, wholesale distributors, 

and repackagers must meet these 

requirements by January 1, 2015; 

dispensers must meet them by July 1, 

2015. In addition, each manufacturer, 

wholesale distributor, dispenser, and 

repackager must comply with all 

applicable requirements in the event 

they meet the definition of more than 

one trading partner under section 

582(a)(1), but trading partners are not 

required to duplicate requirements. 

Section 582(a)(2)(A) of the FD&C Act 

directs FDA to establish initial 

standards to facilitate the interoperable 

exchange of transaction information, 

transaction history, and transaction 

statements between trading partners. 

FDA obtained stakeholder input on 

the development of the initial standards 

for the interoperable exchange of 

product tracing information, in paper 

and electronic formats, through a public 

docket established in February 2014, as 

required under section 582(a)(2)(B), and 

a public workshop that was held May 8 

and 9, 2014. The public workshop 

provided a forum for FDA to obtain 

input from stakeholders in the 

pharmaceutical distribution supply 

chain on how trading partners can best 

comply with the requirements for the 

interoperable exchange of product 

tracing information beginning in 2015, 

using currently available standards or 

practices. Comments to the public 

dockets and from the workshop were 

considered in the development of this 

guidance, and will be considered in 

developing additional guidance to 

further elaborate on the standards for 

the interoperable exchange of product 

tracing information. 

This initial draft guidance establishes 

standards to help trading partners 

comply with the requirements of 

sections 582(b)(1), (c)(1), (d)(1), and 

(e)(1) of the FD&C Act to provide the 

subsequent trading partners with 

product tracing information, in paper or 

electronic format, through the extension 

and/or use of current systems and 

processes. Under these provisions, 

trading partners are also required to 

capture and maintain the applicable 

product tracing information for not less 

than 6 years after the date of the 

transaction. Implementation of these 

provisions will help further improve the 

security of the pharmaceutical 

distribution supply chain and increase 

confidence in the safety and 

authenticity of human prescription 

drugs. FDA intends to issue additional 

guidance to facilitate the interoperable 

exchange of product tracing information 

through standardization of data and 

documentation practices. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance is marked as a ‘‘draft’’ 

consistent with its description in 

section 582(a)(2)(A) of the FD&C Act. 


tkelley on DSK3SPTVN1PROD with NOTICES