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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69497 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR 601.12 and Form FDA 356h 

have been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR 607.26 and Form 

FDA 2830 have been approved under 

OMB control number 0910–0052; the 

collections of information in 21 CFR 

606.121, 606.170, and 610.40 have been 

approved under OMB control number 

0910–0116; and the collections of 

information in 21 CFR 600.14 have been 

approved under OMB control number 

0910–0458. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27521 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–2013–N–0502] 

Report on the Standardization of Risk 

Evaluation and Mitigation Strategies; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Report on the 

Standardization of Risk Evaluation and 

Mitigation Strategies’’ that appeared in 

the Federal Register of September 23, 

2014. The document misstated the name 

of an organization. This document 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Richard Currey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6125, 

Silver Spring, MD 20993–0002, 301– 

796–3918, FAX: 301–595–7910, REMS_

Standardization@fda.hhs.gov; or Adam 

Kroetsch, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1192, Silver Spring, 

MD 20993–0002; 301–796–3842, FAX: 

301–847–8443, REMS_

Standardization@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 23, 2014 

(79 FR 56816), in FR Doc. 2014–22513, 

the following correction is made: 

1. On page 56817, in the third 

column, under ‘‘Draft Report Describing 

Findings Concerning REMS 

Standardization and Plans for Projects 

to Standardize REMS,’’ ‘‘Accreditation 

Commission for Education in Nursing’’ 

is corrected to read ‘‘American Nurses 

Credentialing Center.’’ 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27522 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–2014–N–0001] 

Developing and Using Precision 

Therapies in the ‘‘Omics’’ Era: 

Generating and Interpreting Evidence 

for Rare Subsets; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing a public workshop entitled 

‘‘Developing and Using Precision 

Therapies in the ‘Omics’ Era: Generating 

and Interpreting Evidence for Rare 

Subsets.’’ This public workshop is being 

cosponsored with the Center for 

Translational and Regulatory Sciences 

at the University of Virginia (UVA). The 

goals of this public workshop are to 

facilitate discussion on current 

scientific approaches using rare subsets 

during drug development programs and 

to further seek input from multiple 

stakeholders on approaches to obtain 

evidence that inform the regulatory 

evaluation of therapeutic products in 

rare subsets of patients identified 

through in-vitro diagnostic testing when 

specific, controlled trials are not 

feasible. 

DATES: The public workshop will be 

held on December 12, 2014, from 9 a.m. 

to 5 p.m. Individuals who wish to 

attend the public workshop in person or 

via a live Webcast must register online 

by December 1, 2014, at: https://

www.signup4.net/Public/

ap.aspx?OID=130&EID=DEVE96E. 

Section II of this document provides 

attendance and registration information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Padmaja Mummaneni, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2164, 

Silver Spring, MD 20993–0002, 301– 

796–2027, email: 

padmaja.mummaneni@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Therapeutic products are increasingly 

targeted to patients who have molecular 

characteristics that are diagnostic of a 

particular subtype of disease, prognostic 

for better or worse outcomes, or 

predictive of treatment response. The 

advent of next-generation sequencing 

and other high throughput technologies 

has enabled the development of in-vitro 

diagnostic tests that are able to detect 

rare molecular variations, specifically in 

the patient, tumor, or microbial DNA 

sequence. FDA and UVA are 

cosponsoring an open public workshop 

among stakeholders in the 

pharmaceutical industry, 

representatives from academia, 

regulatory scientists, and other 

interested parties on the development 

and usage of diagnostic and therapeutic 

products that respectively have the 

potential to identify and treat patients 

with rare molecular characteristics. It is 

important for regulatory agencies, 

pharmaceutical and diagnostic 

industries, and the medical community, 

including payers, to have a mutual 

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