8260 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 

References 

EPA. 2009. Endocrine Disruptor Screening 

Program Test Guidelines. OPPTS 890.1300: 

Estrogen Receptor Transcriptional Activation 

(Human Cell Line (HeLa-9903)). Washington, 

DC: U.S. Environmental Protection Agency. 

Available: http://www.regulations.gov/ 

#!documentDetail;D=EPA-HQ-OPPT-2009- 

0576-0006. 

ICCVAM. 2011. ICCVAM Test Method 

Evaluation Report: The LUMI–CELL® ER 

(BG1Luc ER TA) Test Method: An In Vitro 

Assay for Identifying Human Estrogen 

Receptor Agonist and Antagonist Activity of 

Chemicals. Research Triangle Park, NC: 

National Institute of Environmental Health 

Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

ERTA-TMER.htm. 

ICCVAM. 2006. Addendum to ICCVAM 

Evaluation of In Vitro Test Methods for 

Detecting Potential Endocrine Disruptors. 

Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/docs/ 

endo_docs/EDAddendFinal.pdf. 

ICCVAM. 2003a. ICCVAM Evaluation of In 

Vitro Test Methods For Detecting Potential 

Endocrine Disruptors: Estrogen Receptor and 

Androgen Receptor Binding and 

Transcriptional Activation Assays. NIH 

Publication No. 03–4503. Research Triangle 

Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_TMER.htm. 

ICCVAM. 2002a. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Estrogen Receptor Transcriptional Activation 

Assays. NIH Publication No. 03–4505. 

Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/ 

methods/endocrine/end_bckgnd.htm#ERTA. 

ICCVAM. 2002b. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Androgen Receptor Binding Assays. NIH 

Publication No. 03–4506. Research Triangle 

Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_bckgnd.htm#ARBnd. 

ICCVAM. 2002c. Background Review 

Document: Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Estrogen Receptor Binding Assays. NIH 

Publication No. 03–4504. Research Triangle 

Park, NC: National Institute of Environmental 

Health Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/endocrine/ 

end_bckgnd.htm#ERBnd. 

ICCVAM. 2002d. Background Review 

Document. Current Status of Test Methods 

for Detecting Endocrine Disruptors: In Vitro 

Androgen Receptor Transcriptional 

Activation Assays. NIH Publication No. 03– 

4507. Research Triangle Park, NC: National 

Institute of Environmental Health Sciences. 

Available: http://iccvam.niehs.nih.gov/ 

methods/endocrine/end_bckgnd.htm#ARTA. 

ICCVAM. 2002e. Expert Panel Evaluation 

of the Validation Status of In Vitro Test 

Methods for Detecting Endocrine Disruptors: 

Estrogen Receptor and Androgen Receptor 

Binding and Transcriptional Activation 

Assays. Expert Panel Final Report. Research 

Triangle Park, NC: National Institute of 

Environmental Health Sciences. Available: 

http://iccvam.niehs.nih.gov/methods/ 

endocrine/end_EPrpt.htm. 

OECD. 2009. Test No 455: The Stably 

Transfected Human Estrogen Receptor-alpha 

Transcriptional Activation Assay for 

Detection of Estrogenic Agonist-Activity of 

Chemicals. In: OECD Guidelines for the 

Testing of Chemicals, Section 4: Health 

Effects. Paris: OECD Publishing. Available: 

http://www.oecd-ilibrary.org/environment/ 

oecd-guidelines-for-the-testing-of-chemicalssection-4-health-effects_20745788. 

Rogers JM, Denison MS. 2000. 

Recombinant cell bioassays for endocrine 

disruptors: Development of a stably 

transfected human ovarian cell line for the 

detection of estrogenic and anti-estrogenic 

chemicals. In Vitro Mol Toxicol 13(1):67–82. 

Dated: February 7, 2012. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2012–3437 Filed 2–13–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10421] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

Correction 

In notice document 2012–2821 

appearing on pages 6123–6124 in the 

issue of February 7, 2012, make the 

following correction: 

On page 6124, in the first column, in 

the last line, ‘‘April 9, 2012’’ should 

read ‘‘April 3, 2012’’. 

[FR Doc. C1–2012–2821 Filed 2–13–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0110] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Reporting: Manufacturer, Importer, 

User Facility, and Distributor Reporting 

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 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 medical 

device reporting (MDR); manufacturer, 

importer, user facility, and distributor 

reporting. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 16, 2012. 

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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@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 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 8261 

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. 

Medical Device Reporting: 

Manufacturer, Importer, User Facility, 

and Distributor Reporting—21 CFR Part 

803 (OMB Control Number 0910– 

0437)—Extension 

Section 519(a)(1) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i(a)(1)) requires every 

manufacturer or importer to report 

‘‘whenever the manufacturer or 

importer receives or otherwise becomes 

aware of information that reasonably 

suggests that one of its marketed 

devices: (A) May have caused or 

contributed to a death or serious injury, 

or (B) has malfunctioned and that such 

device or a similar device marketed by 

the manufacturer or importer would be 

likely to cause or contribute to a death 

or serious injury if the malfunction were 

to recur.’’ 

Section 519(b)(1)(A) of the FD&C Act 

requires ‘‘whenever a device user 

facility receives or otherwise becomes 

aware of information that reasonably 

suggests that a device has or may have 

caused or contributed to the death or 

serious illness, of a patient of the 

facility, the facility shall, as soon as 

practicable but not later than 10 

working days after becoming aware of 

the information, report the information 

to the Secretary and, if the identity of 

the manufacturer is known, to the 

manufacturer of the device.’’ 

Section 519(b)(1)(B) of the FD&C Act 

requires ‘‘whenever a device user 

facility receives or otherwise becomes 

aware of: (i) Information that reasonably 

suggests that a device has or may have 

caused or contributed to the serious 

illness of, or serious injury to, a patient 

of the facility * * *, shall, as soon as 

practicable but not later than 10 

working days after becoming aware of 

the information, report the information 

to the manufacturer of the device or to 

the Secretary if the identity of the 

manufacturer is not known.’’ 

Complete, accurate, and timely 

adverse event information is necessary 

for the identification of emerging device 

problems. Information from these 

reports will be used to evaluate risks 

associated with medical devices which 

will enable FDA to take appropriate 

regulatory measures in protection of the 

public health under section 519 of the 

FD&C Act. Thus FDA is requesting 

approval for these information 

collection requirements which are being 

implemented under part 803 (21 CFR 

part 803). 

Respondents to this collection of 

information are businesses or other forprofit and nonprofit organizations 

including user facilities, manufacturers, 

and importers of medical devices. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section/ form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

803.19 .................................................................................. 57 4 228 3 684 

803.30 and .32 ..................................................................... 393 2 777 1 777 

803.33 Form FDA 3419 ....................................................... 393 1 393 1 393 

803.40 and .42 ..................................................................... 73 37 2,682 1 2,682 

803.50 and .52 ..................................................................... 1,601 104 166,271 1 166,271 

803.56 .................................................................................. 1,200 63 76,186 1 76,186 

Total .............................................................................. ........................ ........................ ........................ ........................ 246,993 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

803.17 .............................................................. 220 1 220 10 2,200 

803.18 (c) & (d) ................................................ 30,000 1 30,000 1.5 45,000 

Total .......................................................... ............................ ............................ ............................ ............................ 47,200 

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

Part 803 requires user facilities to 

report to the device manufacturer and to 

FDA in case of a death, incidents where 

a medical device caused or contributed 

to a death or serious injury. 

Additionally, user facilities are required 

to annually submit the number and 

summary of advents reported during the 

calendar year, using Form FDA 3419. 

Manufacturers of medical devices are 

required to report to FDA when they 

become aware of information indicating 

that one of their devices may have 

caused or contributed to death or 

serious injury or has malfunctioned in 

such a way that should the malfunction 

recur it would be likely to cause or 

contribute to a death or serious injury. 

Device importers report deaths and 

serious injuries to the manufacturers 

and FDA. Importers report malfunctions 

only to the manufacturers, unless they 

are unknown, then the reports are sent 

to FDA. 

The number of respondents for each 

CFR section in table 1 of this document 

is based upon the number of 

respondents entered into FDA’s internal 

databases. FDA estimates, based on its 

experience and interaction with the 

medical device community, that all 

reporting CFR sections are expected to 

take 1 hour to complete, with the 

exception of § 803.19. Section 803.19 is 

expected to take approximately 3 hours 

to complete, but is only required for 

reporting the summarized data quarterly 

to FDA. By summarizing events, the 

total time used to report for this section 

mstockstill on DSK4VPTVN1PROD with NOTICES

8262 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 

is reduced because the respondents do 

not submit a full report for each event 

they report in a quarterly summary 

report. 

The Agency believes that the majority 

of manufacturers, user facilities, and 

importers have already established 

written procedures to document 

complaints and information to meet the 

MDR requirements as part of their 

internal quality control system. There 

are an estimated 30,000 medical device 

distributors. Although they do not 

submit MDR reports, they must 

maintain records of complaints, under 

§ 803.18(d). 

The Agency has estimated that on 

average 220 user facilities, importers, 

and manufacturers would annually be 

required to establish new procedures, or 

revise existing procedures, in order to 

comply with this provision. 

Therefore, FDA estimates the onetime burden to respondents for 

establishing or revising procedures 

under § 803.17 to be 2,200 hours (220 

respondents x 10 hours). For those 

entities, a one-time burden of 10 hours 

is estimated for establishing written 

MDR procedures. The remaining 

manufacturers, user facilities, and 

importers, not required to revise their 

written procedures to comply with this 

provision, are excluded from the burden 

because the recordkeeping activities 

needed to comply with this provision 

are considered ‘‘usual and customary’’ 

under 5 CFR 1320.3(b)(2). 

Under § 803.18, 30,000 respondents 

represent distributors, importers, and 

other respondents to this information 

collection. FDA estimates that it should 

take them approximately 1.5 hours to 

complete the recordkeeping requirement 

for this section. Total hours for this 

section equal 45,000 hours. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3344 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0081] 

Draft Guidance on Investigational New 

Drug Applications for Positron 

Emission Tomography Drugs; 

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 

‘‘Investigational New Drug Applications 

for Positron Emission Tomography 

(PET) Drugs.’’ The draft guidance is 

intended to assist manufacturers of PET 

drugs in submitting investigational new 

drug applications (INDs). 

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 May 14, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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: 

Kyong (Kaye) Kang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2352, 

Silver Spring, MD 20993, 301–796– 

2050. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled 

‘‘Investigational New Drug Applications 

for Positron Emission Tomography 

(PET) drugs.’’ The draft guidance 

summarizes the IND process for PET 

drugs, makes recommendations for how 

to submit an IND, provides advice on 

expanded access options for 

investigational PET drugs, and describes 

the process for requesting permission to 

charge for an investigational PET drug. 

This 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 submission of INDs for PET 

drugs. 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. 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. Paperwork Reduction Act of 1995 

This draft 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 Reduction Act of 1995 

(44 U.S.C. 3501–3520). INDs and 

requests to charge for a drug under an 

IND are submitted to FDA under part 

312 (21 CFR part 312). NDAs and 

ANDAs are submitted to FDA under 

§§ 314.50 and 314.94 (21 CFR 314.50 

and 3.14.94). The collections of 

information in part 312 and in §§ 314.50 

and 314.94 have been approved under 

OMB control numbers 0910–0014, 

0910–0653, 0910–0651, and 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3319 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0805] 

Dermatologic and Ophthalmic Drugs 

Advisory Committee; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of the meeting of the 

Dermatologic and Ophthalmic Drugs 

mstockstill on DSK4VPTVN1PROD with NOTICES