Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11443 

expenditures in greater detail to 

anticipate any funding issues and to 

meet the requirements of ORR 

regulations at CFR 400.211 to collect 

these data for use in estimating future 

costs of the refugee resettlement 

program. ORR must implement the 

methodology at CFR 400.211 each year 

after receipt of its annual appropriation 

to ensure that appropriated funds will 

be adequate for reimbursement to States 

of the costs for assistance provided to 

entering refugees. The estimating 

methodology prescribed in the 

regulations requires the use of actual 

past costs by program component. In the 

event that the methodology indicates 

that appropriated funds are inadequate, 

ORR must take steps to reduce federal 

expenses, such as by limiting the 

number of months of eligibility for 

Refugee Cash Assistance and Refugee 

Medical Assistance. This proposed 

single-page financial report allows ORR 

to collect the necessary data to ensure 

that funds are adequate for the projected 

need and thereby meet the requirements 

of both the Refugee Act and ORR 

regulations. 

Respondents: State governments, 

Wilson/Fish Alternative Projects. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ORR Financial Status Report .......................................................................... 58 4 0.50 116 

Estimated Total Annual Burden 

Hours: 116. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–04365 Filed 3–2–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0535] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Notification of a 

Health Claim or Nutrient Content Claim 

Based on an Authoritative Statement 

of a Scientific Body 

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. 

DATES: Fax written comments on the 

collection of information by April 2, 

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 0910–0374. 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. 

Notification of a Health Claim or 

Nutrient Content Claim Based on an 

Authoritative Statement of a Scientific 

Body—(OMB Control Number 0910– 

0374)—Extension 

Section 403(r)(2)(G) and (r)(3)(C) of 

the Federal Food, Drug and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

343(r)(2)(G) and (r)(3)(C)), as amended 

by the FDA Modernization Act of 1997, 

provides that any person may market a 

food product whose label bears a 

nutrient content claim or a health claim 

that is based on an authoritative 

statement of a scientific body of the U.S. 

Government or the National Academy of 

Sciences (NAS). Under this section of 

the FD&C Act, a person that intends to 

use such a claim must submit a 

notification of its intention to use the 

claim 120 days before it begins 

marketing the product bearing the 

claim. In the Federal Register of June 

11, 1998 (63 FR 32102), we announced 

the availability of a guidance entitled 

‘‘Guidance for Industry: Notification of 

a Health Claim or Nutrient Content 

Claim Based on an Authoritative 

Statement of a Scientific Body.’’ The 

guidance provides the Agency’s 

interpretation of terms central to the 

submission of a notification and the 

Agency’s views on the information that 

should be included in the notification. 

We believe that the guidance will enable 

persons to meet the criteria for 

notifications that are established in 

section 403(r)(2)(G) and (r)(3)(C) of the 

FD&C Act. In addition to the 

information specifically required by the 

FD&C Act to be in such notifications, 

the guidance states that the notifications 

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11444 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. We intend to 

review the notifications we receive to 

ensure that they comply with the 

criteria established by the FD&C Act. 

In the Federal Register of November 

21, 2014 (79 FR 69494), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received in response to the notice. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the FD&C Act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

403(r)(2)(G) (nutrient content claims) .................................. 1 1 1 250 250 

403(r)(2)(C) (health claims) ................................................. 1 1 1 450 450 

Guidance for notifications .................................................... 2 1 2 1 2 

Total .............................................................................. ........................ ........................ ........................ ........................ 702 

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

These estimates are based on our 

experience with health claims, nutrient 

content claims, and other similar 

notification procedures that fall under 

our jurisdiction. To avoid estimating the 

number of respondents as zero, we 

estimate that there will be one or fewer 

respondents annually for nutrient 

content claim and health claim 

notifications. We estimate that we will 

receive one nutrient content claim 

notification and one health claim 

notification per year over the next 3 

years. 

Section 403(r)(2)(G) and (r)(3)(C) of 

the FD&C Act requires that the 

notification include the exact words of 

the claim, a copy of the authoritative 

statement, a concise description of the 

basis upon which such person relied for 

determining that this is an authoritative 

statement as outlined in the FD&C Act, 

and a balanced representation of the 

scientific literature relating to the 

relationship between a nutrient and a 

disease or health-related condition to 

which a health claim refers or to the 

nutrient level to which the nutrient 

content claim refers. This balanced 

representation of the scientific literature 

is expected to include a bibliography of 

the scientific literature on the topic of 

the claim and a brief, balanced account 

or analysis of how this literature either 

supports or fails to support the 

authoritative statement. 

Since the claims are based on 

authoritative statements of a scientific 

body of the U.S. Government or NAS, 

we believe that the information that is 

required by the FD&C Act to be 

submitted with a notification will be 

readily available to a respondent. 

However, the respondent will have to 

collect and assemble that information. 

Based on communications with firms 

that have submitted notifications, we 

estimate that one respondent will take 

250 hours to collect and assemble the 

information required by the statute for 

a nutrient content claim notification. 

Further, we estimate that one 

respondent will take 450 hours to 

collect and assemble the information 

required by the statute for a health claim 

notification. 

Under the guidance, notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. The 

guidance applies to both nutrient 

content claim and health claim 

notifications. We have determined that 

this information should be readily 

available to a respondent and, thus, we 

estimate that it will take a respondent 1 

hour to incorporate the information into 

each notification. We expect there will 

be two respondents for a total of 2 

hours. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04380 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donor Testing, Donor Notification, and 

‘‘Lookback’’ 

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. 

DATES: Fax written comments on the 

collection of information by April 2, 

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 0910–0116. 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. 

Current Good Manufacturing Practices 

and Related Regulations for Blood and 

Blood Components; and Requirements 

for Donor Testing, Donor Notification, 

and ‘‘Lookback’’—(OMB Control 

Number 0910–0116)—Extension 

All blood and blood components 

introduced or delivered for introduction 

into interstate commerce are subject to 

section 351(a) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

262(a)). Section 351(a) requires that 

manufacturers of biological products, 

which include blood and blood 

components intended for further 

mstockstill on DSK4VPTVN1PROD with NOTICES