598 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

3. Will not affect intrastate aviation in 

Alaska; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2018–01–05 Fokker Services B.V.: 

Amendment 39–19146; Docket No. 

FAA–2017–1182; Product Identifier 

2013–NM–093–AD. 

(a) Effective Date 

This AD becomes effective January 22, 

2018. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Fokker Services B.V. 

Model F28 Mark 0070 and 0100 airplanes, 

certificated in any category, having serial 

numbers 11268 through 11283 inclusive, 

11286, 11289, 11291, 11293, 11295, 11300, 

11303, 11306, 11308, 11310, 11312 through 

11314 inclusive, 11316, 11318, 11321, 11323 

through 11335 inclusive, 11337, 11338, 

11340, 11345, 11349, 11352 through 11361 

inclusive, 11365 through 11367 inclusive, 

11369, 11370, 11372, 11373, 11376 through 

11380 inclusive, 11387, 11388, 11391, 11395, 

11397, 11399, 11404, 11405, 11407, 11411 

through 11419 inclusive, 11425 through 

11428 inclusive, 11432, 11435 through 11439 

inclusive, 11444 through 11450 inclusive, 

11456 through 11460 inclusive, 11464 

through 11469 inclusive. and 11475 through 

11585 inclusive. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 53, Fuselage. 

(e) Reason 

This AD was prompted by an evaluation by 

the design approval holder (DAH) indicating 

that the fuselage frames are subject to 

widespread fatigue damage (WFD). We are 

issuing this AD to prevent cracking of the 

center fuselage, which could result in 

reduced structural integrity of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Action(s) 

Within 30 days after the effective date of 

this AD, request instructions from the 

Manager, International Section, Transport 

Standards Branch, FAA, to address the 

unsafe condition specified in paragraph (e) of 

this AD; and accomplish the actions at the 

times specified in, and in accordance with, 

those instructions. Guidance can be found in 

Mandatory Continuing Airworthiness 

Information (MCAI) European Aviation 

Safety Agency (EASA) AD 2013–0102, dated 

May 2, 2013. 

(h) Alternative Methods of Compliance 

(AMOCs) 

The Manager, International Section, 

Transport Standards Branch, FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Section, send it to the 

attention of the person identified in 

paragraph (i)(2) of this AD. Information may 

be emailed to: 9-ANM-116-AMOCREQUESTS@faa.gov. Before using any 

approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the local flight 

standards district office/certificate holding 

district office. 

(i) Related Information 

(1) Refer to MCAI EASA AD 2013–0102, 

dated May 2, 2013, for related information. 

You may examine the MCAI on the internet 

at http://www.regulations.gov by searching 

for and locating Docket No. FAA–2017–1182. 

(2) For more information about this AD, 

contact Tom Rodriguez, Aerospace Engineer, 

International Section, Transport Standards 

Branch, FAA, 1601 Lind Avenue SW, 

Renton, WA 98057–3356; telephone: 425– 

227–1137; fax: 425–227–1149. 

(j) Material Incorporated by Reference 

None. 

Issued in Renton, Washington, on 

December 26, 2017. 

John P. Piccola, Jr., 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. 2017–28487 Filed 1–4–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 11, 16, 106, 110, 111, 

112, 114, 117, 120, 123, 129, 179, 211, 

and 507 

[Docket No. FDA–2017–N–6908] 

Policy Regarding Certain Entities 

Subject to the Current Good 

Manufacturing Practice and Preventive 

Controls, Produce Safety, and/or 

Foreign Supplier Verification 

Programs; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a 

guidance for industry entitled ‘‘Policy 

Regarding Certain Entities Subject to the 

Current Good Manufacturing Practice 

and Preventive Controls, Produce 

Safety, and/or Foreign Supplier 

Verification Programs.’’ This guidance 

states agency compliance policy 

regarding certain entities and/or 

activities related to the ‘‘farm’’ 

definition, written assurances, food 

contact substances, and human food byproducts for use as animal food. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 5, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 

comments, that information will be 

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


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 599 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment 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 comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, 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–N–6908 for ‘‘Enforcement Policy 

for Certain Entities Subject to 

Requirements in the CGMP and 

Preventive Controls Regulations, the 

Produce Safety Regulation, and the 

Foreign Supplier Verification Programs 

Regulation.’’ Received comments 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 a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be 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 comments. 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 comments 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to Office of Food 

Safety, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration (HFS–300), 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

For questions relating to CGMP, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2166. 

For questions relating to CGMP, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Food for 

Animals: Jeanette Murphy, Center for 

Veterinary Medicine (HFV–200), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–402– 

6246. 

For questions relating to Foreign 

Supplier Verification Programs for 

Importers of Food for Humans and 

Animals: Rebecca Buckner, Office of 

Foods and Veterinary Medicine, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–4576. 

For questions relating to Standards 

for the Growing, Harvesting, Packing, 

and Holding of Produce for Human 

Consumption: Samir Assar, Center for 

Food Safety and Applied Nutrition 

(HFS–317), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1636. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled ‘‘Policy 

Regarding Certain Entities Subject to the 

Current Good Manufacturing Practice 

and Preventive Controls, Produce 

Safety, and/or Foreign Supplier 

Verification Programs: Guidance for 

Industry.’’ We are issuing the guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). In 

accordance with § 10.115(g)(2), we are 

implementing the guidance immediately 

because we have determined that prior 

public participation is not feasible or 

appropriate. Although the guidance 

document is immediately in effect, FDA 

will accept comments at any time. The 

guidance is not subject to Executive 

Order 12866. 

This guidance document concerns 

four of the seven foundational rules that 

we have established in Title 21 of the 

Code of Federal Regulations (21 CFR) as 

part of our implementation of the FDA 

Food Safety Modernization Act (FSMA; 

Pub. L. 111–353). The four final rules 

are entitled ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food’’ (published 

in the Federal Register of September 17, 

2015, 80 FR 55908) (https://

www.fda.gov/food/guidanceregulation/ 

fsma/ucm334115.htm) (part 117); 

‘‘Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Food for 

Animals’’ (published in the Federal 

Register of September 17, 2015, 80 FR 

51670) (https://www.fda.gov/food/ 

guidanceregulation/fsma/ 

ucm366510.htm) (part 507); ‘‘Foreign 

Supplier Verification Programs for 

Importers of Food for Humans and 

Animals’’ (published in the Federal 

Register of November 27, 2015, 80 FR 

74226) (https://www.fda.gov/food/ 

guidanceregulation/fsma/ 

ucm361902.htm) (FSVP regulation); and 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption’’ (published in the 

Federal Register of November 27, 2015, 

80 FR 74354) (https://www.fda.gov/ 

food/guidanceregulation/fsma/ 

ucm334114.htm) (produce safety 

regulation or part 112). 

In the guidance, we state compliance 

policy for certain entities and/or 

activities under these four rules: 

• Specific facilities subject to part 117 

and/or part 507: 

Æ Certain facilities that would qualify 

as secondary activities farms except for 

the ownership of the facility (e.g., 

certain produce packinghouses and 

warehouses, egg packinghouses, grain 

elevators, cotton ginners); 

Æ Facilities that would qualify as 

farms if they did not color RACs; 


daltland on DSKBBV9HB2PROD with RULES
600 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

Æ Facilities that would qualify as 

secondary activities farms except that 

they pack, package, label, and/or hold 

processed food that consists only of 

RACs that have been dried/dehydrated 

to create a distinct commodity (e.g., 

dried beans); 

Æ Farm mixed-type facilities making 

silage food for animals; 

• Written assurances under the 

‘‘customer provisions’’ in part 117 and 

related rules; 

• Importation of food contact 

substances under the FSVP regulation; 

and 

• Certain human food by-products for 

use as animal food, with regard to 

certain requirements under part 507. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in 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 117 have been approved under 

OMB control number 0910–0751. The 

collections of information in part 507 

have been approved under OMB control 

number 0910–0789. The collections of 

information in 21 CFR part 1, subpart L 

have been approved under OMB control 

number 0910–0752. The collections of 

information in part 112 have been 

approved under OMB control number 

0910–0816. 

II. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances or 

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

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: January 2, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00050 Filed 1–4–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 892 

[Docket No. FDA–2017–N–6539] 

Medical Devices; Radiology Devices; 

Classification of the Absorbable 

Perirectal Spacer 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the absorbable perirectal 

spacer 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 absorbable perirectal spacer’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. 

DATES: This order is effective January 5, 

2018. The classification was applicable 

on April 1, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866, 

steven.tjoe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

absorbable perirectal spacer as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA shall classify the 

device by written order within 120 days. 

The classification will be according to 

the criteria under section 513(a)(1) of 

the FD&C Act. Although the device was 

automatically placed within class III, 

the De Novo classification is considered 

to be the initial classification of the 

device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or premarket 

approval application in order to market 

a substantially equivalent device (see 21 

U.S.C. 360c(i), defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 


daltland on DSKBBV9HB2PROD with RULES