40006 Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–1095] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Electronic 

Submission Process for Voluntary 

Allegations to the Center for Devices 

and Radiological Health 

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 

22, 2017. 

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 0910–0769. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A63, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

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. 

Electronic Submission Process for 

Voluntary Allegations to the Center for 

Devices and Radiological Health—OMB 

Control Number 0910–0769—Extension 

This information collection request 

collects information voluntarily 

submitted to Center for Devices and 

Radiological Health (CDRH) on actual or 

potential health risk concerns about a 

medical device or radiological product 

or its use. Because, prior to the 

establishment of the electronic 

submission process for voluntary 

allegations to CDRH, there had been no 

established guidelines or instructions on 

how to submit an allegation to CDRH, 

allegations often contained minimal 

information and were received via 

phone calls, emails, or conversationally. 

CDRH has established a consistent 

format and process for the submission of 

device allegations that enhances our 

timeliness in receiving, assessing, and 

evaluating voluntary allegations. The 

information provided in the allegations 

received by CDRH may be used to 

clarify the recurrence or emergence of 

significant device-related risks to the 

general public and the need to initiate 

educational outreach or regulatory 

action to minimize or mitigate identified 

risks. 

In the Federal Register of May 30, 

2017 (82 FR 24716) 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

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Electronic submission of voluntary allegations to 

CDRH.

700 1 700 .25 (15 minutes) .......... 175 

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

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17836 Filed 8–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0493] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Additional Criteria 

and Procedures for Classifying Overthe-Counter Drugs as Generally 

Recognized as Safe and Effective and 

Not Misbranded 

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 

22, 2017. 

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 0910–0688. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A63, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

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. 

Additional Criteria and Procedures for 

Classifying Over-the-Counter Drugs as 

Generally Recognized as Safe and 

Effective and Not Misbranded—21 CFR 

330.14, OMB Control Number 0910– 

0688—Revision 

This information collection supports 

Agency regulations. Specifically, FDA 

regulations at § 330.14 (21 CFR 330.14) 

establish additional criteria and 

procedures for classifying over-thecounter (OTC) drugs as generally 

recognized as safe and effective and not 

misbranded. These regulations state that 


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