Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67983 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27850 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0190] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Infant Formula Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Infant Formula Requirements’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, e-mail: 

Juanmanuel.Vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 10, 2010 (75 

FR 48350), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0256. The 

approval expires on October 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27849 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0098] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Evaluation of Potential Data Sources 

for the Sentinel Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Evaluation of Potential Data Sources for 

the Sentinel Initiative’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 4, 2009 

(74 FR 45858), the agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0657. The 

approval expires on February 28, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27848 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0536] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request, Guidance for 

Industry on Pharmacogenomic Data 

Submissions; Extension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection resulting 

from recommendations to sponsors 

submitting or holding investigational 

new drug applications (INDs), new drug 

applications (NDAs), or biologic 

licensing applications (BLAs) on what 

pharmacogenomic data should be 

submitted to the agency during the drug 

development process. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 3, 2011. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

301–796–3792, 

Elizabeth.Berbakos@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 


jlentini on DSKJ8SOYB1PROD with NOTICES
67984 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

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, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

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. 

Guidance for Industry on 

Pharmacogenomic Data Submissions 

(OMB Control Number 0910–0557— 

Extension) 

The guidance provides 

recommendations to sponsors 

submitting or holding INDs, NDAs, or 

BLAs on what pharmacogenomic data 

should be submitted to the agency 

during the drug development process. 

Sponsors holding and applicants 

submitting INDs, NDAs, or BLAs are 

subject to FDA requirements for 

submitting to the agency data relevant to 

drug safety and efficacy (§§ 312.22, 

312.23, 312.31, 312.33, 314.50, 314.81, 

601.2, and 601.12). 

The guidance interprets FDA 

regulations for IND, NDA, or BLA 

submissions, clarifying when the 

regulations require pharmacogenomics 

data to be submitted and when the 

submission of such data is voluntary. 

The pharmacogenomic data submissions 

described in the guidance that are 

required to be submitted to an IND, 

NDA, BLA, or annual report are covered 

by the information collection 

requirements under parts 312, 314, and 

601 (21 CFR parts 312, 314, and 601) 

and are approved by OMB under control 

numbers 0910–0014 (part 312—INDs); 

0910–0001 (part 314—NDAs and annual 

reports); and 0910–0338 (part 601— 

BLAs). 

The guidance distinguishes between 

pharmacogenomic tests that may be 

considered valid biomarkers appropriate 

for regulatory decision-making, and 

other, less well-developed exploratory 

tests. The submission of exploratory 

pharmacogenomic data is not required 

under the regulations, although the 

agency encourages the voluntary 

submission of such data. 

The guidance describes the voluntary 

genomic data submission (VGDS) that 

can be used for such a voluntary 

submission. The guidance does not 

recommend a specific format for the 

VGDS, except that such a voluntary 

submission be designated as a VGDS. 

The data submitted in a VGDS and the 

level of detail should be sufficient for 

FDA to be able to interpret the 

information and independently analyze 

the data, verify results, and explore 

possible genotype-phenotype 

correlations across studies. FDA does 

not want the VGDS to be overly 

burdensome and time-consuming for the 

sponsor. 

FDA has estimated the burden of 

preparing a voluntary submission 

described in the guidance that should be 

designated as a VGDS. Based on FDA’s 

experience with this guidance over the 

past few years, and on FDA’s familiarity 

with sponsors’ interest in submitting 

pharmacogenomic data during the drug 

development process, FDA estimates 

that approximately seven sponsors will 

submit approximately one VGDS and 

that, on average, each VGDS will take 

approximately 50 hours to prepare and 

submit to FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency 

per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Voluntary Genomic Data Submissions Total ....................... 7 1 7 50 350 

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

Dated: October 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27847 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0381] 

Generic Drug User Fee; Notice of 

Public Meeting; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

December 6, 2010, the comment period 

for the notice of public meeting entitled 

Generic Drug User Fee; Public Meeting; 

Request for Comments, published in the 

Federal Register of August 9, 2010 (75 

FR 47820). In that notice, FDA 

announced a public meeting that took 

place on September 17, 2010, to gather 

stakeholder input on the development 

of a generic drug user fee program. FDA 

is reopening the comment period to 

permit public consideration of latereceived comments and to provide an 

opportunity for all interested parties to 

provide information and share views on 

the matter. 

DATES: Submit either electronic or 

written comments by December 6, 2010. 


jlentini on DSKJ8SOYB1PROD with NOTICES