69494 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

Substances Prohibited From Use in 

Animal Food or Feed—21 CFR Part 589 

(OMB Control Number 0910–0627— 

Revision) 

This regulation prohibits the use of 

certain cattle origin materials in the 

food or feed of all animals to help 

prevent the spread of bovine spongiform 

encephalopathy (BSE) in United States’ 

cattle. BSE is a progressive and fatal 

neurological disorder of cattle that 

results from an unconventional 

transmissible agent. BSE belongs to the 

family of diseases known as 

transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. These measures will 

further strengthen existing safeguards 

against BSE. 

Description of Recordkeeping for 

Respondents: Rendering facilities, 

medicated feed manufacturers, livestock 

feeders. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section 589.2001; substances 

prohibited from use in animal food or 

feed 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

Total hours 

Operating and 

maintenance 

costs 

589.2001(c)(2)(vi) and (c)(3)(i) ................ 175 1 175 20 3,500 $59,500 

589.2001(c)(2)(ii) ...................................... 50 1 50 20 1,000 17,000 

589.2001(c)(3)(i)(A) .................................. 175 1 175 26 4,550 80,580 

Total .................................................. ........................ ........................ ........................ ........................ 9,050 157,080 

1There are no capital costs associated with this collection of information. 

The number of recordkeepers times 

the number of records per recordkeeper 

equals total annual records. Total 

annual records times average burden per 

recordkeeper equals total hours. 

Description of Respondents for 

Reporting: The final regulation on BSE 

(73 FR 22720) included a provision that 

exempts cattle materials prohibited in 

animal feed (CMPAF) from designated 

countries from the prohibition on its use 

in animal feed. A foreign country 

seeking this designation will submit a 

written request to FDA that includes a 

variety of information about the 

country’s BSE status (§ 589.2001(f)). 

During the past 6 years, FDA received 

2 requests from countries to be 

exempted from CMPAF restrictions. 

FDA estimates the reporting burden 

for this information collection as 

follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section 589.2001(f) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

respondent 

Total hours 

One-time (initial) burden ...................................................... 1 1 1 80 80 

Burden from future review ................................................... 1 1 1 26 26 

1There are no capital costs or operating costs associated with the collection of information. 

One-Time (initial) Reporting Burden 

There will be a one-time burden to 

countries that apply to FDA seeking to 

be designated as not subject to 

restrictions applicable to CMPAF. We 

estimate that each country that applies 

for an exclusion will spend 80 hours 

putting information together to submit 

to FDA. Table 2 row 1 presents the onetime burden for the exclusion. (See final 

BSE regulation at 73 FR 22754). 

Recurring Burden 

Countries that successfully petition 

FDA to be designated as exempt from 

certain BSE-related restrictions 

applicable to animal feed will be subject 

to future review by FDA to ensure that 

their designation remains appropriate. 

As part of this process, FDA may ask 

designated countries from time to time 

to confirm that their BSE situation and 

the information submitted by them in 

support of their original application 

remains unchanged. We assume it will 

take FDA and the designated country 

undergoing a review in the future about 

one third the time and effort it did when 

the information was submitted. Table 2 

row 2 presents the expected recurring 

burden. 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27518 Filed 11–20–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0535] 

Agency Information Collection 

Activities; Proposed Collection; 

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 or we) is 

announcing an opportunity for public 

comment on our 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, 

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Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69495 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment. 

This notice invites comments on the 

collection of information associated 

with the submission of notifications of 

health claims or nutrient content claims 

based on authoritative statements of 

scientific bodies of the U.S. 

Government. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 20, 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, 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. 

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 

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. 

We estimate 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. 

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69496 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

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: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27517 Filed 11–20–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 1999–D–3528 (Formerly 

Docket No. 1999D–5046)] 

Changes to an Approved Application: 

Biological Products: Human Blood and 

Blood Components Intended for 

Transfusion or for Further 

Manufacture; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Changes to an Approved Application: 

Biological Products: Human Blood and 

Blood Components Intended for 

Transfusion or for Further Manufacture; 

Guidance for Industry’’ dated December 

2014. The guidance document provides 

manufacturers of licensed whole blood 

and blood components intended for 

transfusion or for further manufacture, 

including source plasma, with 

recommendations concerning 

submission of changes to an approved 

biologics license application (BLA). The 

guidance document also provides 

manufacturers of licensed whole blood 

and blood components 

recommendations in connection with 

the applicability and content of 

comparability protocols and labeling 

changes. The guidance applies to the 

manufacture and distribution of 

licensed products. The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

June 2013 and supersedes the document 

of the same title dated July 2001 (July 

2001 guidance). 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), 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 the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

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: 

Jonathan McKnight, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Changes to an 

Approved Application: Biological 

Products: Human Blood and Blood 

Components Intended for Transfusion 

or for Further Manufacture; Guidance 

for Industry’’ dated December 2014. The 

guidance document provides 

manufacturers of licensed whole blood 

and blood components intended for 

transfusion or for further manufacture, 

including source plasma, with 

recommendations concerning 

submission of changes to an approved 

BLA in accordance with the 

requirements under Title 21 of the Code 

of Federal Regulations 601.12 (21 CFR 

601.12). The guidance document also 

provides manufacturers of licensed 

whole blood and blood components 

with recommendations in connection 

with the applicability and content of 

comparability protocols under 

§ 601.12(e) and labeling changes under 

§ 601.12(f). Frequently, a manufacturer 

of a licensed product determines that it 

is appropriate to make a change in its 

product, production process, quality 

controls, equipment, facilities, 

responsible personnel, or labeling as 

documented in its approved BLA(s). 

Section 601.12 states the requirements 

to report such changes for licensed 

biological products to FDA. 

The recommendations contained in 

the guidance document reflect current 

FDA and industry experience with 

reporting changes to an approved 

application, including reporting the 

implementation of new technologies. 

The recommendations have been 

revised for reporting categories for 

certain changes to an approved 

application that were in the July 2001 

guidance based on the experience 

gained over the last decade. 

In the Federal Register of May 31, 

2013 (78 FR 32668), FDA announced the 

availability of the draft guidance of the 

same title dated June 2013. FDA 

received several comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. In response to comments, the 

guidance includes the addition of 

numerous appendices with tables to 

highlight the appropriate reporting 

categories related to certain 

manufacturing changes. The guidance 

announced in this notice finalizes the 

draft guidance dated June 2013. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. 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 statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

The 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 

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