Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 20825 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: March 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8342 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0144] 

Guidance for Industry and Food and 

Drug Administration Staff; User Fees 

for 513(g) Requests for Information; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; User Fees for 

513(g) Requests for Information.’’ This 

guidance document describes the user 

fees associated with 513(g) requests for 

information. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

User Fees for 513(g) Requests for 

Information’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4613, 

Silver Spring, MD 20993–0002 or Office 

of Communication, Outreach and 

Development (HFM–40), 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Bob Gatling, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1640, 

Silver Spring, MD 20993–0002, 301– 

796–6560; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852. 301–796–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 513(g) of the Federal Food, 

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

(21 U.S.C. 360c(g)) provides a means for 

obtaining FDA’s views about 

classification information and the 

regulatory requirements that may be 

applicable to a particular device. Title II 

of the Food and Drug Administration 

Amendments Act of 2007 (FDAAA), 

also termed the Medical Device User 

Fee Amendments of 2007 (Pub. L. 110– 

85), extends FDA’s authority to collect 

medical device user fees by establishing 

a fee for ‘‘a request for classification 

information.’’ 

In the Federal Register of April 29, 

2010 (75 FR 22601), FDA announced the 

availability of the draft guidance. 

Comments on the draft guidance were 

due by July 28, 2010. No comments 

were received. The guidance announced 

in this notice finalizes the draft 

guidance of the same title. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a document 

announcing the availability of a 

guidance document entitled ‘‘Guidance 

for Industry and Food and Drug 

Administration Staff; FDA and Industry 

Procedures for Section 513(g) Requests 

for Information under the Federal Food, 

Drug, and Cosmetic Act.’’ This guidance 

describes procedures for the 

submission, FDA review, and FDA 

response to requests for information 

with respect to the classification of a 

device or the requirements applicable to 

a device submitted in accordance with 

section 513(g) requests for information. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on user fees for 513(g) 

requests for information. 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or from 

the CBER Internet site at http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/default.htm. To 

receive ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

User Fees for 513(g) Requests for 

Information,’’ you may either send an 

email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8419 to receive a hard copy. Please 

use the document number 1709 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that 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). The collection(s) of information 

in this guidance was approved under 

OMB control number 0910–0705. 

This guidance also refers to currently 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120 

and the collections of information in 21 

CFR part 814 have been approved under 

OMB control number 0910–0231. 

V. 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

20826 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 

Dated: March 29, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–8227 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0153] 

Guidance for Industry and Food and 

Drug Administration Staff; Food and 

Drug Administration and Industry 

Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; FDA and 

Industry Procedures for Section 513(g) 

Requests for Information under the 

Federal Food, Drug, and Cosmetic Act.’’ 

This guidance document establishes the 

procedures for the submission, FDA 

review, and FDA response to requests 

for information regarding the class in 

which a device has been classified. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

FDA and Industry Procedures for 

Section 513(g) Requests for Information 

under the Federal Food, Drug, and 

Cosmetic Act’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002 or Office 

of Communication, Outreach and 

Development (HFM–40), 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8419. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Bob Gatling, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1640, 

Silver Spring, MD 20993–0002, 301– 

796–6560; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 513(g) of the Federal Food, 

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

(21 U.S.C. 360c(g)) provides a means for 

obtaining FDA’s views about the 

classification and the regulatory 

requirements that may be applicable to 

a particular device. This guidance 

describes procedures for the 

submission, FDA review, and FDA 

response to requests for information 

with respect to the classification of a 

device or the requirements applicable to 

a device under the FD&C Act that are 

submitted in accordance with section 

513(g) requests for information. FDA’s 

response to section 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. 

In the Federal Register of April 29, 

2010 (75 FR 22599), FDA announced the 

availability of the draft guidance. 

Comments on the draft guidance were 

due by July 28, 2010. No comments 

were received. The guidance announced 

in this notice finalizes the draft 

guidance of the same title. 

Additionally, the FD&C Act, as 

amended by the FDA Amendments Act 

of 2007 (FDAAA) (Pub. L. 110–85), 

requires FDA to collect user fees for 

section 513(g) requests for information. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a document 

announcing the availability of a 

guidance entitled ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; User Fees for 

513(g) Requests for Information.’’ 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on procedures 

regarding section 513(g) requests. 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or from 

the CBER Internet site at http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/default.htm. To 

receive ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

FDA and Industry Procedures for 

Section 513(g) Requests for Information 

under the Federal Food, Drug, and 

Cosmetic Act,’’ you may either send an 

email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8419 to receive a hard copy. Please 

use the document number 1671 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that 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). The collection(s) of information 

in this guidance was approved under 

OMB control number 0910–0705. 

This guidance also refers to currently 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 807 subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; and 

the collections of information in 21 CFR 

860.123 have been approved under 

OMB control number 0910–0138. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

mstockstill on DSK4VPTVN1PROD with NOTICES