Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24721 

1OCRA Student Rate applies to those individuals 

enrolled full time in a Regulatory or Quality related 

academic program at an accredited institution. 

Proof of enrollment is required. 

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 May 25, 

2012. 

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–New and 

title ‘‘Revisions to Labeling 

Requirements for Blood and Blood 

Components, Including Source Plasma.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: ≤Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@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. 

Revisions to Labeling Requirements for 

Blood and Blood Components, 

Including Source Plasma—(OMB 

Control Number 0910–NEW) 

FDA is finalizing the labeling 

requirements for blood or blood 

components intended for use in 

transfusion or for further manufacture 

under the provisions of the Public 

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

262–264), and the drugs, devices, and 

general administrative provisions of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 321, 331, 351– 

353, 355, 360, 360j, 371, and 374). 

Under these provisions of the PHS Act 

and the FD&C Act, we have the 

authority to issue and enforce 

regulations designed to ensure that 

biological products are safe, pure, 

potent, and properly labeled, and to 

prevent the introduction, transmission, 

and spread of communicable disease. 

Under this rulemaking, FDA is 

consolidating the regulations related to 

labeling blood and blood components. 

Regulations for labeling of blood and 

blood components will be consolidated 

into § 606.121 (Container label) (21 CFR 

606.121) and § 606.122 (Circular of 

information) (21 CFR 606.122). This 

notice solicits comments on the 

information collection associated with 

§ 606.121(c)(11), which requires that if 

the product is intended for further 

manufacturing use, a statement listing 

the results of all the tests for 

communicable disease agents required 

under § 610.40 (21 CFR 610.40) for 

which the donation has been tested and 

found negative must be on the container 

label; except that the label for Source 

Plasma is not required to list the 

negative results of serological syphilis 

testing under § 610.40(i) and 21 CFR 

640.65(b). In addition, this notice also 

solicits comments on the information 

collection associated with 

§ 606.121(e)(2)(i), which requires that 

the product labels of certain red blood 

cells must include the type of additive 

solution with which the product was 

prepared. 

The Agency believes the rule 

amendments and the information 

collection provisions under 

§ 606.121(c)(11) and (e)(2)(i) in the final 

rule are part of usual and customary 

business practice and do not create any 

new burden for respondent. 

The collection of information 

requirements under §§ 606.121 and 

606.122 are approved under OMB 

control number 0910–0116 and those in 

21 CFR 640.70 have been approved 

under OMB control number 0910–0338. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. 

In the Federal Register of December 

30, 2011 (76 FR 82300), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

Dated: April 19, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9894 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

The 15th Annual Food and Drug 

Administration—Orange County 

Regulatory Affairs Educational 

Conference in Irvine, CA; ‘‘Sustainable 

Regulatory Practices’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: The 15th Annual 

Educational Conference cosponsored 

with the Orange County Regulatory 

Affairs Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics, and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the Centers and District Offices, as well 

as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive Q & A, and workshop 

sessions will also be included to assure 

open exchange and dialogue on the 

relevant regulatory issues. 

Date and Time: The conference will 

be held on June 6 and 7, 2012, from 7:30 

a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, Fax: 

949–608–4417, or OCRA, Attention to 

Detail, 5319 University Dr., suite 641, 

Irvine, CA 92612, 949–387–9046, Fax: 

949–266–8461, Web site: www.ocradg.org. (FDA has verified the Web site 

address, but FDA is not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register). 

Registration and Meeting Information: 

See OCRA Web site, www.ocra-dg.org. 

Contact Attention to Detail, 949–387– 

9046. 

Before May 8, 2012, registration fees 

are as follows: $675 for members, $725 

for non-members and $475 for FDA/ 

Government/Students.1 After May 8, 

2012, fees will be $725 for members, 

$775 for non-members, and $475 for 


pmangrum on DSK3VPTVN1PROD with NOTICES
24722 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

2See footnote 1. 

FDA/Government/Students.2 There will 

also be a 1-day rate of $425 for OCRA 

members and $475 for non-members. 

The registration fee will cover actual 

expenses, including refreshments, 

lunch, materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley (see Contact) at least 10 days 

before the conference. 

Dated: April 20, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9968 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0489] 

Draft Guidance for Industry: Safety of 

Nanomaterials in Cosmetic Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: Safety 

of Nanomaterials in Cosmetic 

Products.’’ The draft guidance, when 

finalized, will represent FDA’s current 

thinking on the safety assessment of 

nanomaterials in cosmetic products. 

This guidance is intended to assist 

industry in identifying the potential 

safety issues of nanomaterials in 

cosmetic products and developing a 

framework for evaluating them. 

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 July 24, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Cosmetics and Colors, Center 

for Food Safety and Applied Nutrition 

(HFS–100), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kapal Dewan, Center for Food Safety 

and Applied Nutrition (HFS–125), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–1130. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

the draft guidance entitled ‘‘Guidance 

for Industry: Safety of Nanomaterials in 

Cosmetic Products.’’ The draft guidance 

is intended to assist industry in 

identifying the potential safety issues of 

nanomaterials in cosmetic products and 

developing a framework for evaluating 

these issues. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the safety of nanomaterials in 

cosmetic products. 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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/CosmeticGuidances 

or http://www.regulations.gov. Always 

access an FDA guidance document by 

using FDA’s Web site listed previously 

to find the most current version of the 

guidance. 

Dated: April 17, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9934 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0490] 

Draft Guidance for Industry: Assessing 

the Effects of Significant 

Manufacturing Process Changes, 

Including Emerging Technologies, on 

the Safety and Regulatory Status of 

Food Ingredients and Food Contact 

Substances, Including Food 

Ingredients That Are Color Additives; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Assessing the 

Effects of Significant Manufacturing 

Process Changes, Including Emerging 

Technologies, on the Safety and 

Regulatory Status of Food Ingredients 

and Food Contact Substances, Including 

Food Ingredients That Are Color 

Additives.’’ The draft guidance, when 

finalized, will explain FDA’s current 

thinking on the factors to be considered 

when determining whether changes in 

manufacturing process, including the 

intentional reduction in particle size to 

the nanoscale, for a food substance 

already in the market affects the safety 

and regulatory status of the food 

substance, and whether a new 

regulatory submission to FDA is 

warranted. 

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 written or electronic comments 

on the draft guidance by July 24, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

entitled ‘‘Guidance for Industry: 

Assessing the Effects of Significant 

Manufacturing Process Changes, 

Including Emerging Technologies, on 

the Safety and Regulatory Status of Food 

Ingredients and Food Contact 

Substances, Including Food Ingredients 

That Are Color Additives’’ to the Office 

of Food Additive Safety (HFS–200), 


pmangrum on DSK3VPTVN1PROD with NOTICES