Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 19 

Agency Law Name/description CFR Citation 

2017 2018 

Min penalty 

(rounded to 

nearest 

dollar) 

Max penalty 

(rounded to 

nearest dollar) 

Min penalty 

(rounded to 

nearest 

dollar) 

Max penalty 

(rounded to 

nearest dollar) 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits for mines with 

fewer than 25 employees.

20 CFR 

726.302(c)(2)(i).

136 ................................... 139 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits for mines with 

25–50 employees.

20 CFR 

726.302(c)(2)(i).

272 ................................... 278 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits for mines with 

51–100 employees.

20 CFR 

726.302(c)(2)(i).

409 ................................... 417 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits for mines with 

more than 100 employees.

20 CFR 

726.302(c)(2)(i).

544 ................................... 555 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits after 10th day 

of notice.

20 CFR 

726.302(c)(4).

136 ................................... 139 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits for repeat offenders.

20 CFR 

726.302(c)(5).

409 ................................... 417 

OWCP ............ Black Lung Benefits 

Act.

Failure to secure 

payment of benefits.

20 CFR 

726.302(c)(5).

.................... 2,795 ........................ .................... 2,852. 

Signed at Washington, DC, this 22nd day 

of December, 2017. 

R. Alexander Acosta, 

Secretary, U.S. Department of Labor. 

[FR Doc. 2017–28224 Filed 12–29–17; 8:45 am] 

BILLING CODE 4510–HL–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2017–F–2130] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; Formic 

Acid as a Feed Acidifying Agent in 

Complete Poultry Feeds 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we, the Agency) 

is amending the regulations for food 

additives permitted in feed and drinking 

water of animals to provide for the safe 

use of formic acid as a feed acidifying 

agent in complete poultry feeds. This 

action is in response to a food additive 

petition filed by BASF Corp. 

DATES: This rule is effective January 2, 

2018. Submit either written or 

electronic objections and requests for a 

hearing by February 1, 2018. See section 

V of this document for information on 

the filing of objections. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Objections submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

objection, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–F–2130 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 

of Animals; Formic Acid as a Feed 

Acidifying Agent in Complete Poultry 

Feeds.’’ Received objections will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit an objection with confidential 

information that you do not wish to be 

made publicly available, submit your 

objections only as a written/paper 

submission. You should submit two 

copies in total. One copy will include 

the information you claim to be 


daltland on DSKBBV9HB2PROD with RULES
20 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

confidential with a heading or cover 

note that states ‘‘THIS DOCUMENT 

CONTAINS CONFIDENTIAL 

INFORMATION.’’ The Agency will 

review this copy, including the claimed 

confidential information, in its 

consideration of objections. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your objections and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper objections 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Chelsea Trull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6729, 

chelsea.trull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of May 30, 2017 (82 FR 

24611), FDA announced that we had 

filed a food additive petition (animal 

use) (FAP 2301) submitted by BASF 

Corp., 100 Park Ave., Florham Park, NJ 

07932. The petition proposed that the 

regulations for food additives permitted 

in feed and drinking water of animals be 

amended to provide for the safe use of 

formic acid as a feed acidifying agent in 

complete poultry feeds. 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of formic acid as 

an acidifying agent in complete poultry 

feeds and that the food additive 

regulations should be amended as set 

forth in this document. This is not a 

significant regulatory action subject to 

Executive Order 12866. 

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. 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 Dockets Management Staff (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 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, and will be posted to the docket 

at https://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. In § 573.480, revise paragraph (b) 

introductory text and paragraph 

(b)(5)(iii)(B) to read as follows: 

§ 573.480 Formic acid. 

* * * * * 

(b) The additive is used or intended 

for use as a feed acidifying agent, to 

lower the pH, in complete swine and 

poultry feeds at levels not to exceed 1.2 

percent of the complete feed. 

* * * * * 

(5) * * * 

(iii) * * * 

(B) Contact address and telephone 

number for reporting adverse reactions 

or to request a copy of the Safety Data 

Sheet (SDS). 

* * * * * 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28251 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 864 

[Docket No. FDA–2017–N–6780] 

Medical Devices; Hematology and 

Pathology Devices; Classification of 

the Whole Slide Imaging System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the whole slide imaging 

system into class II (special controls). 

The special controls that apply to the 

device type are identified in this order 

and will be part of the codified language 

for the whole slide imaging system’s 

classification. We are taking this action 

because we have determined that 

classifying the device into class II 

(special controls) will provide a 

reasonable assurance of safety and 

effectiveness of the device. We believe 

this action will also enhance patients’ 

access to beneficial innovative devices, 

in part by reducing regulatory burdens. 


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