67154 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations 
In addition, the petition proposed that 
the animal food additive regulations for 
formic acid and ammonium formate be amended to limit formic acid and formate salts from all added sources to 1.2 percent of complete feeds. This element of the petition was not described in the July 2014 notice of petition. 
Elsewhere in this issue of the Federal 
Register, FDA is providing notice of BASF Corp.’s proposal that FDA amend the food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources to 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. 
II. Conclusion 
FDA concludes that the data establish 
the safety and utility of feed grade 
sodium formate for use as a feed acidifying agent in complete swine feeds and that the food additive regulations should be amended as set forth in this document. 
III. Public Disclosure 
In accordance with § 571.1(h) (21 CFR 
571.1(h)), the petition and documents 
we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see 
FOR FURTHER  
INFORMATION CONTACT ). As provided in 
§ 571.1(h), we will delete from the documents any materials that are not available for public disclosure. 
IV. Analysis of Environmental Impact 
The Agency has determined under 21 
CFR 25.32(r) that this action is of a type 
that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required. 
V. Objections and Hearing Requests 
Any person who will be adversely 
affected by this regulation may file with 
the Division of Dockets Management (see 
ADDRESSES ) either electronic or 
written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. 
Any objections received in response 
to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. 
List of Subjects in 21 CFR Part 573 
Animal feeds, Food additives. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows: 
PART 573—FOOD ADDITIVES 
PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 
■1. The authority citation for part 573 
continues to read as follows: 
Authority: 21 U.S.C. 321, 342, 348. 
■2. Add § 573.696 to read as follows: 
§ 573.696 Feed grade sodium formate. 
The food additive, feed grade sodium 
formate, may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: 
(a) The additive is manufactured by 
the reaction of 99 percent formic acid and 50 percent sodium hydroxide in water to produce a solution made up of at least 20.5 percent sodium salt of formic acid and not more than 61 percent formic acid. 
(b) The additive is used or intended 
for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 1.2 percent of the complete feed. 
(c) To assure safe use of the additive, 
formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. 
(d) To assure safe use of the additive, 
in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: 
(1) The name of the additive. 
(2) Adequate directions for use, 
including a statement that feed grade 
sodium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing feed grade sodium formate. 
(3) Cautions for use including this 
statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. 
(e) To assure safe use of the additive, 
in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain: 
(1) Appropriate warnings and safety 
precautions concerning feed grade sodium formate. 
(2) Statements identifying feed grade 
sodium formate as a corrosive and possible severe irritant. 
(3) Information about emergency aid 
in case of accidental exposure as follows: 
(i) Statements reflecting requirements 
of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration (OSHA) human safety guidance regulations. 
(ii) Contact address and telephone 
number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS). 
Dated: September 26, 2016. 
Tracey H. Forfa, 
Deputy Director, Center for Veterinary 
Medicine. 
[FR Doc. 2016–23671 Filed 9–29–16; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 882 
[Docket No. FDA 2016–N–2677] 
Medical Devices; Neurological 
Devices; Classification of the Evoked Photon Image Capture Device 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 
DATES : This order is effective September 
30, 2016. The classification was applicable on July 15, 2016. 
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FOR FURTHER INFORMATION CONTACT : 
Kristen Bowsher, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993–0002, 301–796–6448, kristen.bowsher@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
In accordance with section 513(f)(1) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. 
Section 513(f)(2) of the FD&C Act (21 
U.S.C. 360c(f)(2)), as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with 
the device or if FDA determines that the device submitted is not of ‘‘low- moderate risk’’ or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. 
In response to a request to classify a 
device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On January 12, 2015, EPIC Research & Diagnostics, Inc. submitted a request for classification of the EPIC ClearView
TM 
System under section 513(f)(2) of the FD&C Act. 
In accordance with section 513(f)(2) of 
the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class I if general controls by themselves are sufficient to provide reasonable assurance of safety and effectiveness of the device for its intended use. After review of the information submitted in the de novo request, FDA determined that the device 
can be classified into class I. FDA believes general controls will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on July 15, 2016, FDA 
issued an order to the requestor classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 882.1561. 
The device is assigned the generic 
name evoked photon image capture device, and it is identified as a prescription, electrically-powered device intended for use as a non- invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes. 
FDA has identified the following risks 
to health associated specifically with this type of device: Adverse tissue reaction, electromagnetic incompatibility, and electromagnetic malfunction (e.g., shock). 
Evoked photon image capture devices 
are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices). II. Analysis of Environmental Impact 
The Agency has determined under 21 
CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 
III. Paperwork Reduction Act of 1995 
This final order refers to previously 
approved collections of information 
found in other 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). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910–0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 882 
Medical devices, Neurological 
devices. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: 
PART 882—NEUROLOGICAL DEVICES 
■1. The authority citation for part 882 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 371. 
■2. Add § 882.1561 to subpart B to read 
as follows: 
§ 882.1561 Evoked photon image capture 
device. 
(a) Identification. An evoked photon 
image capture device is a prescription, 
electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes. 
(b) Classification. Class I (general 
controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 882.9. 
Dated: September 26, 2016. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2016–23633 Filed 9–29–16; 8:45 am] 
BILLING CODE 4164–01–P 
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