Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Rules and Regulations 45927 

[FR Doc. 2012–18516 Filed 8–1–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 774 

The Commerce Control List 

CFR Correction 

In Title 15 of the Code of Federal 

Regulations, Parts 300 to 799, revised as 

of January 1, 2012, in supplement no. 1 

to part 774, in Category 6, make the 

following corrections: 

■ 1. In 6A001: 

■ A. On page 807, in the note following 

paragraph 6A001.a.1, add ‘‘equipment 

as follows’’ after ‘‘6A001.a.1 does not 

control’’. 

■ B. On page 807, in paragraph a.1.a.1.a, 

remove ‘‘20’’ and add ‘‘20°’’ in its place. 

■ C. On page 810, designating the notes 

following 6A001.b.2 as ‘‘Note 1’’ and 

‘‘Note 2’’. 

■ D. On page 810, removing the note to 

6A001.a.2 following the N.B. at the end 

of the section. 

■ 2. In 6A992, on page 826, in the table 

for ‘‘License Requirements’’, remove the 

entry for RS and place it below the table 

as an indented paragraph. 

■ 3. In 6B108, on page 830, remove 

‘‘Unit: r’’ and add ‘‘Unit: Number’’ in its 

place. 

■ 4. In 6C005, on page 831, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

■ 5. In 6D001, on page 831, remove 

‘‘CIV: * * *’’ and add ‘‘CIV: N/A’’ in its 

place. 

■ 6. In 6D003: 

■ A. On page 832, in ‘‘Reason for 

Control’’, after ‘‘NS’’, add ‘‘RS,’’. 

■ B. On page 833, remove paragraphs 

h.1.a and h.1.b. 

■ 7. In 6E001, on page 834, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

■ 8. In 6E002, on page 835, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

[FR Doc. 2012–18967 Filed 8–1–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 807 

[Docket No. FDA–2009–N–0114] 

RIN 0910–AF88 

Implementation of Device Registration 

and Listing Requirements Enacted in 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002, the Medical 

Device User Fee and Modernization 

Act of 2002, and Title II of the Food and 

Drug Administration Amendments Act 

of 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to reflect recent statutory 

amendments to the device registration 

and listing provisions of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), enacted on September 

27, 2007, amended the FD&C Act by 

requiring domestic and foreign device 

establishments to begin submitting their 

registration and device listing 

information to FDA by electronic means 

rather than on paper forms, and also 

specified the timeframes when 

establishments are required to submit 

such information. In addition, this final 

rule would facilitate FDA’s collection of 

additional registration information from 

foreign establishments as required by 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Bioterrorism 

Act). The final rule will update certain 

provisions in the regulations to improve 

the quality of registration and listing 

information available to FDA. FDA 

relies on having complete and accurate 

registration and listing information in 

order to accomplish a number of 

important public health objectives. 

DATES: This final rule is effective 

October 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Ann Ferriter, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 2680, 

Silver Spring, MD 20993–0002, 301– 

796–5686; and 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Overview of the Final Rule 

III. Comments on the Proposed Rule 

IV. Legal Authority 

V. Analysis of Economic Impacts 

VI. Paperwork Reduction Act of 1995 

VII. Environmental Impact 

VIII. Federalism 

IX. References 

I. Background 

We originally published 

establishment registration regulations 

for medical devices in the Federal 

Register of September 3, 1976 (41 FR 

37458) (proposed rule) and August 23, 

1977 (42 FR 42520) (final rule), and 

device listing regulations in the Federal 

Register of September 30, 1977 (42 FR 

52808) (proposed rule), and August 25, 

1978 (43 FR 37990) (final rule). 

These regulations called for 

establishment registration and device 

listing information to be submitted to 

the Center for Devices and Radiological 

Health (CDRH) on several paper forms: 

FDA 2891, Registration of Device 

Establishment; FDA 2891a, Annual 

Registration of Device Establishment; 

and FDA 2892, Device Listing. Once 

these forms were completed and 

submitted to FDA, FDA then forwarded 

them to a data entry contractor who 

entered the information into FDA’s 

device registration and listing database. 

In June 2002, section 321 of the 

Bioterrorism Act (Pub. L. 107–188) 

amended section 510(i) of the FD&C Act 

(21 U.S.C. 360(i)) to require those 

foreign establishments who are required 

to register with FDA to do so by 

electronic means, and to include 

additional information identifying 

certain parties involved in the 

importation of the foreign 

establishment’s devices into the United 

States as part of their registration. 

Subsequently, in October 2002, section 

207 of the Medical Device User Fee and 

Modernization Act (MDUFMA) (Pub. L. 

107–250) further amended section 510 

of the FD&C Act by extending the 

requirement for electronic submission of 

registration information to include 

domestic firms as well as foreign firms. 

However, when adding these new 

electronic submission requirements, 

which appear in section 510(p) of the 

FD&C Act, Congress chose to delay their 

implementation so that FDA would 

have an opportunity to first put systems 

in place to accommodate the electronic 

receipt of registration information. This 

was accomplished by including a 


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