10586 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, VOR RWY 36, Amdt 2, 

CANCELED 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, VOR/DME RWY 1, Amdt 

1 

Effective 2 April 2015 

Truckee, CA, Truckee-Tahoe, RNAV 

(GPS) Z RWY 20, Orig–A 

RESCINDED: On January 15, 2015 (80 

FR 2009), the FAA published an 

Amendment in Docket No. 30990, Amdt 

No. 3619, to Part 97 of the Federal 

Aviation Regulations under section 

97.23, 97.27, and 97.29. The following 

entries for Baton Rouge, LA, effective 

January 8, 2015 are hereby rescinded in 

their entirety: 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 13, Amdt 27E 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 22R, Amdt 11B 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, NDB RWY 

31, Amdt 2D 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR RWY 

4L, Amdt 17C 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR/DME 

RWY 22R, Amdt 8H 

[FR Doc. 2015–03931 Filed 2–26–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0393] 

RIN 0910–AF86 

Medical Device Reporting: Electronic 

Submission Requirements; Correcting 

Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; correcting 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulation regarding postmarket 

electronic Medical Device Reporting 

(eMDR) to address the unintentional 

removal of certain provisions of the 

Unique Device Identification (UDI) 

System regulations and to update the 

contact information listed in the 

regulations. 

DATES: This rule is effective August 14, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Kapsch, Office of Surveillance 

and Biometrics, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–6104, 

Sharon.Kapsch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 24, 2013 

(78 FR 58786), FDA published the 

‘‘Unique Device Identification System’’ 

final rule (UDI rule). The UDI rule, 

among other things, amended part 803 

(21 CFR part 803). These amendments 

became effective on December 23, 2013. 

In the Federal Register of February 

14, 2014 (79 FR 8832), FDA published 

the ‘‘Medical Device Reporting: 

Electronic Submission Requirements’’ 

final rule (eMDR rule). The eMDR rule 

will become effective on August 14, 

2015. The eMDR rule, among other 

things, revises part 803 in its entirety. 

As published in the Federal Register, 

the eMDR rule will, upon its effective 

date, unintentionally remove the 

amendments made by the UDI rule to 

part 803 of the Code of Federal 

Regulations (CFR), Title 21. This 

document addresses the unintentional 

removal by amending part 803 to 

include the UDI requirements. 

When the eMDR rule goes into effect, 

it will require changes to the CFR 

citations of some provisions within part 

803; consequently, some of the citations 

used by the UDI rule will have to be 

updated. The following table provides 

the ‘‘Original UDI Citation’’ (the citation 

used by the September 24, 2013, UDI 

rule) and the corresponding ‘‘Updated 

Citation’’ for provisions addressed in 

this document. 

TABLE 1—CITATIONS IN PART 803; UDI CITATION AND CORRESPONDING UPDATED CITATION

Provision Original UDI citation 1 Updated citation 2

Amendment of 803.3—Definitions of human cell, tissue, or cellular or tissuebased product (HCT/P) regulated as a device and unique device identifier 

(UDI).

Listed alphabetically within 

803.3.

803.3(aa) and 803.3(bb), respectively. 

Amendment of section 803.32 ................................................................................. 803.32(c)(6) ........................... 803.32(c)(4). 

Amendment of section 803.33 ................................................................................. 803.33(a)(7)(iv) ...................... 803.33(b)(7)(iv). 

Amendment of section 803.42 ................................................................................. 803.42(c)(6) ........................... 803.42(c)(4). 

Amendment of section 803.52 ................................................................................. 803.52(c)(6) ........................... 803.52(c)(4). 

1The ‘‘Original UDI Citation’’ is the citation within part 803, as amended by the UDI rule, which became effective on December 23, 2013. 

2The ‘‘Updated Citation’’ is the citation within part 803, after the changes made by the eMDR rule go into effect on August 14, 2015, and after 

those changes are further amended by the correcting amendments in this document. 

We are also updating the contact 

information listed in §§ 803.11 and 

803.33 for the Division of International 

and Consumer Education (DICE) 

(formerly the Division of Small 

Manufacturers, International and 

Consumer Assistance (DSMICA)). 

FDA is publishing this document as a 

final rule under the Administrative 

Procedures Act (5 U.S.C. 551, et seq.). 

FDA has determined that good cause 

exists to dispense with prior notice and 

public comment under 5 U.S.C. 

553(b)(3)(B) and 21 CFR 10.40(e)(1) 

because the provisions addressed in this 

document have already undergone 

notice and public comment. 

Additionally, the amendments to 

§§ 803.11 and 803.33, to provide 

updated contact information, are 

editorial in nature and are intended to 

improve the accuracy of the Agency’s 

regulations. 

FDA has determined under 21 CFR 

25.30(i) that this final rule 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. 

This final rule 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 (the PRA). The 

revised Form FDA 3500A is approved 

under OMB control number 0910–0291. 

The collections of information in part 

803 have been approved under OMB 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 10587 

control number 0910–0437. The 

collections of information in the UDI 

rule have been approved under OMB 

control number 0910–0720. 

The information collection provisions 

in the eMDR rule have been submitted 

to OMB for review as required by 

section 3507(d) of the PRA (44 U.S.C. 

3507(d)). Before the effective date of the 

final rule, FDA will publish a notice in 

the Federal Register announcing OMB’s 

decision to approve, modify, or 

disapprove the information collection 

provisions in the final rule. 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. 

List of Subjects in 21 CFR Part 803 

Imports, Medical devices, Reporting 

and recordkeeping requirements. 

Therefore under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 803 as 

amended by the Medical Device 

Reporting: Electronic Submission 

Requirements final rule of February 14, 

2014, 79 FR 8832, is further amended as 

follows: 

PART 803—MEDICAL DEVICE 

REPORTING 

■ 1. The authority citation for 21 CFR 

part 803 continues to read as follows: 

Authority: 21 U.S.C. 352, 360, 360i, 360j, 

371, 374. 

■ 2. Amend § 803.3 by adding 

paragraphs (aa) and (bb) to read as 

follows: 

§ 803.3 How does FDA define the terms 

used in this part? 

* * * * * 

(aa) Human cell, tissue, or cellular or 

tissue-based product (HCT/P) regulated 

as a device means an HCT/P as defined 

in § 1271.3(d) of this chapter that does 

not meet the criteria in § 1271.10(a) and 

that is also regulated as a device. 

(bb) Unique device identifier (UDI) 

means an identifier that adequately 

identifies a device through its 

distribution and use by meeting the 

requirements of § 830.20 of this chapter. 

A unique device identifier is composed 

of: 

(1) A device identifier—a mandatory, 

fixed portion of a UDI that identifies the 

specific version or model of a device 

and the labeler of that device; and 

(2) A production identifier—a 

conditional, variable portion of a UDI 

that identifies one or more of the 

following when included on the label of 

the device: 

(i) The lot or batch within which a 

device was manufactured; 

(ii) The serial number of a specific 

device; 

(iii) The expiration date of a specific 

device; 

(iv) The date a specific device was 

manufactured. 

(v) For an HCT/P regulated as a 

device, the distinct identification code 

required by § 1271.290(c) of this 

chapter. 

* * * * * 

■ 3. Amend § 803.11 by revising 

paragraph (d) to read as follows: 

§ 803.11 What form should I use to submit 

reports of individual adverse events and 

where do I obtain these forms? 

* * * * * 

(d) Form FDA 3500A is available on 

the Internet at http://www.fda.gov/

medwatch/getforms.htm or from 

Division of International and Consumer 

Education, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4621, Silver Spring, 

MD 20993–0002, by email: DICE@

fda.hhs.gov, FAX: 301–847–8149, or 

telephone: 800–638–2041. 

■ 4. Amend § 803.32 by revising 

paragraph (c)(4) to read as follows: 

§ 803.32 If I am a user facility, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

■ 5. Amend § 803.33 by revising 

paragraphs (a)(2) and (b)(7)(iv) to read as 

follows: 

§ 803.33 If I am a user facility, what must 

I include when I submit an annual report? 

* * * * * 

(a) * * * 

(2) Division of International and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4621, Silver Spring, 

MD 20993–0002, by email: DICE@

fda.hhs.gov, FAX: 301–847–8149, or 

telephone: 800–638–2041. 

* * * * * 

(b) * * * 

(7) * * * 

(iv) Product model, catalog, serial, 

and lot number and unique device 

identifier (UDI) that appears on the 

device label or on the device package; 

* * * * * 

■ 6. Amend § 803.42 by revising 

paragraph (c)(4) to read as follows: 

§ 803.42 If I am an importer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

■ 7. Amend § 803.52 by revising 

paragraph (c)(4) to read as follows: 

§ 803.52 If I am a manufacturer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03943 Filed 2–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9712] 

RIN 1545–BL78 

Alternative Simplified Credit Election 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and removal of 

temporary regulations. 

SUMMARY: This document contains final 

regulations relating to the election of the 

alternative simplified credit under 

section 41(c)(5) of the Internal Revenue 

Code (Code). The final regulations affect 

certain taxpayers claiming the credit 

under section 41. 

DATES: Effective Date: These regulations 

are effective on February 27, 2015. 

Applicability Date: For dates of 

applicability, see § 1.41–9(d). 


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