47144 Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices 

presented reports relevant and therefore 

unable to rate a report) and that 65 

percent of the eligible sample will 

complete, resulting in 319 completes. It 

should take about 30 minutes to 

complete the Stakeholder Survey. 

Mathematica will conduct seniistructured Key Informant Interviews, on 

average lasting 50 minutes, with 23 

respondents. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Expert Survey .................................................................................................. 54 1 .33 18 

Expert Consultation ......................................................................................... 15 1 .17 3 

Stakeholder Survey ......................................................................................... 319 1 .50 160 

Key Informant Interviews ................................................................................. 23 1 .83 19 

Total .......................................................................................................... 411 ........................ ........................ 200 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Expert Survey .................................................................................................. 54 17.8 $92.25 $1,642 

Expert Consultation ......................................................................................... 15 2.5 ** 92.25 231 

Stakeholder Survey ......................................................................................... 319 59.5 *** 48.72 7,771 

Key Informant Interviews ................................................................................. 23 19.1 38.68 739 

Total .......................................................................................................... 411 ........................ ........................ 10,383 

* May 2013 National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. 

** Based on average wage for physicians and surgeons. 

*** Based on average wage for medical and health services managers. 

**** Based on average wage for social scientists and related workers. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: July 30 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–18972 Filed 8–11–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10305] 

Agency Information Collection 

Activities: Proposed Collection; 

Extension of Comment Period 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Agency information collection 

activities: Proposed collection; comment 

request; extension of comment period. 

SUMMARY: This notice extends the 

comment period for a 60-day notice 

request for proposed information 

collection request associated with the 

notice [Document Identifier: CMS– 

10305] entitled ‘‘Medicare Part C and 

Part D Data Validation’’ that was 

published in the June 13, 2014 (79 FR 

33927) Federal Register. The comment 

period for the information collection 

request, which would have ended on 

August 12, 2014, is extended to August 

26, 2014. 

DATES: The comment period for the 

information collection request 

published in the June 13, 2014, Federal 

Register (79 FR 33927) is extended to 

August 26, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices 47145 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: 

In the FR Doc. 2014–13863 of June 13, 

2014 (79 FR 33927), we published a 

Paperwork Reduction Act notice 

requesting a 60-day public comment 

period for the document entitled 

‘‘Medicare Part C and Part D Data 

Validation.’’ There were technical 

delays with making the information 

collection request publicly available; 

therefore, in this notice we are 

extending the comment period from the 

date originally listed in the June 13, 

2014, notice. 

Dated: August 7, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–19027 Filed 8–11–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1030] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Allergen 

Labeling and Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing an opportunity for public 

comment on our proposed collection of 

certain information. 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 and to allow 60 days for 

public comment in response to the 

notice. This notice invites comments on 

the information collection provisions of 

the labeling requirements for major food 

allergens in the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) and the 

information collection provisions of the 

draft guidance entitled, ‘‘Draft Guidance 

for Industry: Food Allergen Labeling 

Exemption Petitions and Notifications.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 14, 2014. 

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 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, we are publishing notice of 

the proposed collection of information 

set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of our functions, including whether the 

information will have practical utility; 

(2) the accuracy of our 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. 

Food Allergen Labeling and 

Reporting—(OMB Control Number 

0910–NEW) 

I. Background 

The Food Allergen Labeling and 

Consumer Protection Act of 2004 

(FALCPA) (Title II, Pub. L. 108–282) 

amended the FD&C Act by defining the 

term ‘‘major food allergen’’ and stating 

that foods regulated under the FD&C Act 

are misbranded unless they declare the 

presence of each major food allergen on 

the product label using the name of the 

food source from which the major food 

allergen is derived. Section 403(w)(1) of 

the FD&C Act (21 U.S.C. 343(w)(1)) sets 

forth the requirements for declaring the 

presence of each major food allergen on 

the product label. Section 201(qq) of the 

FD&C Act (21 U.S.C. 321(qq)) defines a 

major food allergen as ‘‘[m]ilk, egg, fish 

(e.g., bass, flounder, or cod), Crustacean 

shellfish (e.g., crab, lobster, or shrimp), 

tree nuts (e.g., almonds, pecans, or 

walnuts), wheat, peanuts, and 

soybeans’’ and also as a food ingredient 

that contains protein derived from such 

foods. The definition excludes any 

highly refined oil derived from a major 

food allergen and any ingredient 

derived from such highly refined oil. 

In some cases, the production of an 

ingredient derived from a major food 

allergen may alter or eliminate the 

allergenic proteins in that derived 

ingredient to such an extent that it does 

not contain allergenic protein. In 

addition, a major food allergen may be 

used as an ingredient or as a component 

of an ingredient such that the level of 

allergenic protein in finished food 

products does not cause an allergic 

response that poses a risk to human 

health. Therefore, FALCPA provides 

two mechanisms through which such 

ingredients may become exempt from 

the labeling requirement of section 

403(w)(1) of the FD&C Act. An 

ingredient may obtain an exemption 

through submission and approval of a 

petition containing scientific evidence 

that demonstrates that the ingredient 

‘‘does not cause an allergic response 

that poses a risk to human health’’ 

(section 403(w)(6) of the FD&C Act (21 

U.S.C. 343(w)(6)). Alternately, an 

ingredient may become exempt through 

submission of a notification containing 

scientific evidence showing that the 

ingredient ‘‘does not contain allergenic 

protein’’ or that there has been a 

previous determination through a 

premarket approval process under 

section 409 of the FD&C Act (21 U.S.C. 

348) that the ingredient ‘‘does not cause 

an allergic response that poses a risk to 

human health’’ (section 403(w)(7) of the 

FD&C Act (21 U.S.C. 343(w)(7)). 


emcdonald on DSK67QTVN1PROD with NOTICES