Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51373 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1

21 CFR Section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours 

107.230 ............................................................ 2 1 2 50 100 

107.260 ............................................................ 1 1 1 25 25 

Total .......................................................... ............................ ............................ ............................ ............................ 125 

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

New table 2 reports the Agency’s 

third-party disclosure burden estimates 

for §§ 107.230 and 107.260. The 

estimated burden hours per disclosure 

is an average based on the Agency’s 

experience. The third-party disclosure 

burden in § 107.230 is the requirement 

to promptly notify each affected directaccount (customer) about the recall and 

if the recalled formula presents a risk to 

human health, the requirement that the 

recalling firm must also request that 

each establishment that sells the 

recalled formula post (at the point of 

purchase) a notice of the recall. We 

estimate that two respondents will 

conduct infant formula recalls under 

§ 107.230 and that it will take a 

respondent 50 hours to comply with the 

third-party disclosure requirements of 

that section, for a total of 100 hours. The 

third-party disclosure burden in 

§ 107.260 is the requirement to issue 

additional notifications where the recall 

strategy or implementation is 

determined to be deficient. We estimate 

that one respondent will issue 

additional notifications under § 107.260 

and that it will take a respondent 25 

hours to comply with the third-party 

disclosure requirements of that section, 

for a total of 25 hours. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21040 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0402] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Petitions for 

Exemption From Preemption 

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 September 

19, 2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0277. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

State Petitions for Exemption From 

Preemption—21 CFR 100.1(d) (OMB 

Control Number 0910–0277)—Extension 

Under section 403A(b) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 343–1(b)), States 

may petition FDA for exemption from 

Federal preemption of State food 

labeling and standard of identity 

requirements. Section 100.1(d) (21 CFR 

100.1(d)) sets forth the information a 

State is required to submit in such a 

petition. The information required 

under § 100.1(d) enables FDA to 

determine whether the State food 

labeling or standard of identity 

requirement satisfies the criteria of 

section 403A(b) of the FD&C Act for 

granting exemption from Federal 

preemption. 

In the Federal Register of June 10, 

2011 (76 FR 34082), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

100.1(d) ................................................................................ 1 1 1 40 40 

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

The reporting burden for § 100.1(d) is 

minimal because petitions for 

exemption from preemption are seldom 

submitted by States. In the last 3 years, 

FDA has not received any new petitions 

for exemption from preemption; 

therefore, the Agency estimates that one 

or fewer petitions will be submitted 

annually. Although FDA has not 

received any new petitions for 

exemption from preemption in the last 

3 years, it believes these information 

collection provisions should be 

extended to provide for the potential 

future need of a State or local 

mstockstill on DSK4VPTVN1PROD with NOTICES

51374 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

government to petition for an exemption 

from preemption under the provisions 

of section 403A of the FD&C Act. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21041 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Direct Discovery of HLA Associated 

Influenza Epitopes Isolated From 

Human Cells for Vaccine and 

Therapeutic Evaluation and 

Development (U01) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of a sole source cooperative 

agreement with the University of 

Oklahoma Health Sciences Center. The 

goal of the FDA, Center for Drug 

Evaluation and Research, Office of Chief 

Scientist, is to develop technology to 

molecularly characterize peptide 

epitopes that are processed and 

presented on soluble HLA (human 

leucocyte antigen) expressed by human 

cells. Initial studies will examine and 

characterize influenza peptides isolated 

from several different soluble Class I 

HLAs produced from influenza infected 

human lung cell lines. There is a 

growing interest in developing universal 

vaccines for influenza by targeting 

conserved internal proteins to stimulate 

cross-protective CTLs (cytolytic T 

lymphocyte) to provide long-lasting 

immunity. It is therefore critically 

important to identify which viral 

epitopes are generated by antigen 

processing in influenza infected lung 

cells, the target cells of cell mediated 

immune response to respiratory viruses. 

FDA seeks a collaboration to develop 

this technology for this purpose which 

can then be applied to identifying and 

characterizing other HLA-presented 

epitopes in viral infections, cancer, and 

immune toxicities. 

DATES: Important dates are as follows: 

1. The application due date is 

September 1, 2011. 

2. The anticipated start date is 

November 1, 2011. 

3. The opening date is August 18, 

2011. 

4. The expiration date is November 2, 

2011. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

For Programmatic questions and 

concerns contact: Michael Norcross, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 9000 Rockville Pike, 

N29B, Rm. 4NN (HFD 122), Bethesda, 

MD 20892, Telephone: 301–827–0793; 

E-mail: Michael.norcross@fda.hhs.gov. 

For Financial and Administrative 

questions and concerns contact: Gladys 

M. Bohler, Food and Drug 

Administration, Office of Acquisitions 

and Grant Services, 5630 Fisher’s Lane, 

Rm. 1078 (HFA 500), Rockville, MD 

20857, Telephone: 301–827–7175, 

E-mail: gladys.bohler@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at: http:// 

www.fda.gov/AboutFDA/CentersOffices/ 

CDER/ucm088761.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Funding Opportunity Number: RFA–FD–12– 

001. 

Catalog of Federal Domestic Assistance 

Number: 93.103. 

A. Background 

Knowledge on how viral and self 

proteins are processed and presented in 

HLA molecules is important to 

understand how the body defends itself 

from infection and how immune 

responses can lead to tissue toxicities. 

Developing technology to allow direct 

identification of epitopes bound by HLA 

molecules is critical to vaccine and 

therapeutic immune strategies. FDA is 

interested in collaborative research to 

develop and implement this technology 

which will be valuable in evaluation 

and review of vaccines and 

therapeutics. Initial studies will address 

identifying epitopes from influenza that 

are presented by different HLA alleles in 

infected lung cells. 

Influenza virus infection affects a 

significant proportion of the population 

and is associated with serious morbidity 

and mortality. Although many epitopes 

can be predicted by computer programs 

and by screening peripheral blood cells 

with panels of viral peptides from 

influenza, the peptides that are 

presented on the infected target cells in 

the tissues and the infiltrating T cells 

that recognize the HLA-peptide 

complexes are the critical elements to 

control and recover from infection. The 

technology of directly identifying viral 

epitopes in HLA can elucidate viral 

targets for T cells and provide the 

foundation for new approaches for rapid 

development of effective vaccines. More 

effective vaccines to prevent and control 

influenza infections will have broad 

public health benefits by reducing 

morbidity and mortality of this 

infectious disease. 

B. Research Objectives 

For this purpose, a direct epitope 

elution approach is needed to allow 

milligram quantities of HLA-peptide 

complexes to be purified from influenza 

infected lung cells lines that express 

soluble HLA. Human lung cell lines 

engineered to secrete soluble HLA from 

three supertypes (A*01, A*03, and 

B*27) should be infected with at least 

two current influenza strains and HLA 

collected during infection. HLA will be 

purified and bound peptides eluted. 

Influenza peptides should be 

systematically identified by mass 

spectrometry analysis and sequencing. 

Synthetic viral peptides can then be 

tested for binding to recombinant HLA 

to verify binding specificity and affinity. 

Influenza epitopes identified in this 

initial phase of the project can be 

evaluated for immunogenicity and 

antigenicity in follow up studies. 

This project will provide the 

regulatory science to facilitate 

development and evaluation of direct 

discovery of HLA presented epitopes. 

The direct epitope methodology will be 

applied to current influenza strains 

initially, but has the flexibility to 

address novel pandemic strains and 

other pathological agents. 

Goal 1: Identify virus-encoded class I 

HLA peptides presented during 

influenza infection of human lung cells. 

Goal 2: In vitro validation of class I 

HLA-presented influenza peptides. 

Goal 3: Develop HLA-epitope directdiscovery technology for use in FDA 

laboratories. 

C. Eligibility Information 

The technology requires extensive 

infrastructure for growing cells, 

purifying HLA from culture 

supernatants, and for mass spectrometry 

analysis. Staff at the University of 

Oklahoma Health Sciences Center are 

leaders in this technology and have 

published the first reports on applying 

this method to influenza. Support of 

this project will allow the extension of 

the methodology to examine other HLA 

types. FDA believes this is a novel and 

valuable methodology that should be 

implemented at FDA. Funding this 

collaborative initiative will allow FDA 

to acquire the proteomic expertise, 

training, and tissue culture support to 

establish a laboratory in the field of 

immunoproteomics. The direct 

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