Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51635 

TABLE 1—CLASS II DEVICES—Continued 

21 CFR section Device type Product 

code 

Partial exemption limitation 

(if applicable) 

866.5950 ............... Genetic Health Risk Assessment System .................... PTA Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the 

genetic health risk assessment system (a ‘‘one-time 

FDA reviewed genetic health risk assessment system’’). 

876.1500 ............... Endoscopic Maintenance System ................................. PUP 

880.6710 ............... Purifier, Water, Ultraviolet, Medical ............................... KMG 

884.5960 ............... Vibrator for Therapeutic Use, Genital ........................... KXQ 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the Web site address, as of the date this 

document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA Guidance, ‘‘Procedures for Class II 

Device Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff,’’ February 19, 1998, 

available at https://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM080199.pdf. 

Dated: October 31, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24163 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–N–0618; FDA– 

2013–N–1155; FDA–2010–N–0118; FDA– 

2011–N–0655; FDA–2014–N–0086; FDA– 

2011–N–0144; FDA–2016–N–2836] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. 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. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Reporting and Recordkeeping for Electronic Products—General Requirements ................................................... 0910–0025 7/31/2020 

Food Labeling Regulations ...................................................................................................................................... 0910–0381 7/31/2020 

Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 ........................................................................................................................................................... 0910–0520 7/31/2020 

Animal Generic Drug User Fee Act Cover Sheet ................................................................................................... 0910–0632 7/31/2020 

Potential Tobacco Product Violations Reporting Form ........................................................................................... 0910–0716 7/31/2020 

Voluntary Qualified Importer Program Guidance for Industry ................................................................................. 0910–0840 7/31/2020 

Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored 

Transfusion-Transmissible Infectious Monitoring System ................................................................................... 0910–0841 7/31/2020 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24189 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 


ethrower on DSK3G9T082PROD with NOTICES