This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

50663 

Vol. 76, No. 158 

Tuesday, August 16, 2011 

DEPARTMENT OF ENERGY 

Federal Energy Regulatory 

Commission 

18 CFR Part 292 

[Docket No. RM09–23–000] 

Revisions to Form, Procedures and 

Criteria for Certification of Qualifying 

Facility Status for a Small Power 

Production or Cogeneration Facility 

AGENCY: Federal Energy Regulatory 

Commission. 

ACTION: Correcting amendment. 

SUMMARY: This document contains 

corrections to final regulations which 

were published in the Federal Register 

of Tuesday, March 30, 2010. The final 

rule document adopted revisions to 

FERC Form 556 and to Commission 

procedures and criteria for the 

certification of qualifying facility status 

for a small power production or 

cogeneration facility. 

DATES: August 16, 2011. 

FOR FURTHER INFORMATION CONTACT: S.L. 

Higginbottom (Legal Information), 

Office of the General Counsel, Federal 

Energy Regulatory Commission, 888 

First Street, NE., Washington, DC 20426, 

Telephone: 202–502–8561, E-mail: 

samuel.higginbottom@ferc.gov. 

SUPPLEMENTARY INFORMATION: The final 

regulations amended 18 CFR 292.205 

and affect the Commission’s criteria and 

procedures for the certification of 

qualifying facility status for small power 

production or cogeneration facilities. 

As published, the final regulations 

contained errors; they incorrectly 

removed paragraphs from 18 CFR 

292.205(d). These paragraphs contain 

critical criteria for new cogeneration 

facilities. 

List of Subjects in 18 CFR Part 292 

Electric power, Electric power plants, 

Electric utilities. 

Accordingly, 18 CFR part 292 is 

corrected by making the following 

correcting amendment: 

Subchapter K—Regulations Under The 

Public Utility Regulatory Policies Act of 

1978 

PART 292—REGULATIONS UNDER 

SECTION 201 AND 210 OF THE 

PUBLIC UTILITY REGULATORY 

POLICIES ACT OF 1978 WITH REGARD 

TO SMALL POWER PRODUCTION AND 

COGENERATION 

■ 1. The authority citation for part 292 

continues to read as follows: 

Authority: 16 U.S.C. 791a–825r, 2601– 

2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352. 

■ 2. Section 292.205 is amended by 

adding paragraphs (d)(1) through (5) to 

read as follows: 

§ 292.205 Criteria for qualifying 

cogeneration facilities. 

* * * * * 

(d) * * * 

(1) The thermal energy output of the 

cogeneration facility is used in a 

productive and beneficial manner; and 

(2) The electrical, thermal, chemical 

and mechanical output of the 

cogeneration facility is used 

fundamentally for industrial, 

commercial, residential or institutional 

purposes and is not intended 

fundamentality for sale to an electric 

utility, taking into account 

technological, efficiency, economic, and 

variable thermal energy requirements, as 

well as state laws applicable to sales of 

electric energy from a qualifying facility 

to its host facility. 

(3) Fundamental use test. For the 

purpose of satisfying paragraph (d)(2) of 

this section, the electrical, thermal, 

chemical and mechanical output of the 

cogeneration facility will be considered 

used fundamentally for industrial, 

commercial, or institutional purposes, 

and not intended fundamentally for sale 

to an electric utility if at least 50 percent 

of the aggregate of such output, on an 

annual basis, is used for industrial, 

commercial, residential or institutional 

purposes. In addition, applicants for 

facilities that do not meet this safe 

harbor standard may present evidence 

to the Commission that the facilities 

should nevertheless be certified given 

state laws applicable to sales of electric 

energy or unique technological, 

efficiency, economic, and variable 

thermal energy requirements. 

(4) For purposes of paragraphs (d)(1) 

and (2) of this section, a new 

cogeneration facility of 5 MW or smaller 

will be presumed to satisfy the 

requirements of those paragraphs. 

(5) For purposes of paragraph (d)(1) of 

this section, where a thermal host 

existed prior to the development of a 

new cogeneration facility whose thermal 

output will supplant the thermal source 

previously in use by the thermal host, 

the thermal output of such new 

cogeneration facility will be presumed 

to satisfy the requirements of paragraph 

(d)(1). 

Dated: August 9, 2011. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2011–20751 Filed 8–15–11; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 870 and 884 

[Docket No. FDA–2010–N–0412] 

Effective Date of Requirement for 

Premarket Approval for Three Class III 

Preamendments Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the following three 

class III preamendments devices: 

Ventricular bypass (assist) device; 

pacemaker repair or replacement 

material; and female condom. The 

Agency has summarized its findings 

regarding the degree of risk of illness or 

injury designed to be eliminated or 

reduced by requiring the devices to 

meet the statute’s approval requirements 

and the benefits to the public from the 

use of the devices. This action 

implements certain statutory 

requirements. 

DATES: This rule is effective August 23, 

2011. 


jlentini on DSK4TPTVN1PROD with RULES
50664 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: 

Michael Ryan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1615, Silver Spring, 

MD 20993–0002, 301–796–6283. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (SMDA) (Pub. L. 101–629), the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Pub. L. 105–115), the Medical Device 

User Fee and Modernization Act of 2002 

(Pub. L. 107–250), and the Food and 

Drug Administration Amendments Act 

of 2007 (Pub. L. 110–85), among other 

amendments, established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: 

(1) Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless, and 

until, the device is reclassified into class 

I or II or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

FD&C Act, 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 21 CFR part 807. 

A preamendments device that has 

been classified into class III may be 

marketed by means of premarket 

notification procedures (510(k) process) 

without submission of a PMA until FDA 

issues a final regulation under section 

515(b) of the FD&C Act (21 U.S.C. 

360e(b)) requiring premarket approval. 

Section 515(b)(1) established the 

requirement that a preamendments 

device that FDA has classified into class 

III is subject to premarket approval. A 

preamendments class III device may be 

commercially distributed without an 

approved PMA or a notice of 

completion of a PDP until 90 days after 

FDA issues a final rule requiring 

premarket approval for the device, or 30 

months after final classification of the 

device under section 513 of the FD&C 

Act, whichever is later. Also, a 

preamendments device subject to the 

rulemaking procedure under section 

515(b) is not required to have an 

approved investigational device 

exemption (IDE) (see part 812 (21 CFR 

part 812)) contemporaneous with its 

interstate distribution until the date 

identified by FDA in the final rule 

requiring the submission of a PMA for 

the device. At that time, an IDE is 

required only if a PMA has not been 

submitted or a PDP completed. 

Section 515(b)(2)(A) of the FD&C Act 

provides that a proceeding to issue a 

final rule to require premarket approval 

shall be initiated by publication of a 

notice of proposed rulemaking 

containing: (1) The regulation; (2) 

proposed findings with respect to the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the device to have an 

approved PMA or a declared completed 

PDP and the benefit to the public from 

the use of the device; (3) an opportunity 

for the submission of comments on the 

proposed rule and the proposed 

findings; and (4) an opportunity to 

request a change in the classification of 

the device based on new information 

relevant to the classification of the 

device. 

Section 515(b)(2)(B) of the FD&C Act 

provides that if FDA receives a request 

for a change in the classification of the 

device within 15 days of the publication 

of the notice, FDA shall, within 60 days 

of the publication of the notice, consult 

with the appropriate FDA advisory 

committee and publish a notice denying 

the request for change in reclassification 

or announcing its intent to initiate a 

proceeding to reclassify the device 

under section 513(e) of the FD&C Act. 

Section 515(b)(3) of the FD&C Act 

provides that FDA shall, after the close 

of the comment period on the proposed 

rule and consideration of any comments 

received, issue a final rule to require 

premarket approval or publish a 

document terminating the proceeding 

together with the reasons for such 

termination. If FDA terminates the 

proceeding, FDA is required to initiate 

reclassification of the device under 

section 513(e) of the FD&C Act, unless 

the reason for termination is that the 

device is a banned device under section 

516 of the FD&C Act (21 U.S.C. 360f). 

When a rule to require premarket 

approval for a preamendments device is 

finalized, section 501(f)(2)(B) of the 

FD&C Act (21 U.S.C. 351(f)(2)(B)) 

requires that a PMA or notice of 

completion of a PDP for any such device 

be filed within 90 days of the date of 

issuance of the final rule or 30 months 

after the final classification of the device 

under section 513 of the FD&C Act, 

whichever is later. If a PMA or notice of 

completion of a PDP is not filed by the 

latter of the two dates, commercial 

distribution of the device must cease 

since the device would be deemed 

adulterated under section 501(f). 

The device may, however, be 

distributed for investigational use if the 

manufacturer, importer, or other 

sponsor of the device complies with the 

IDE regulations. If a PMA or notice of 

completion of a PDP is not filed by the 

latter of the two dates, and no IDE is in 

effect, the device is deemed to be 

adulterated within the meaning of 

section 501(f)(1)(A) of the FD&C Act, 

and subject to seizure and 

condemnation under section 304 of the 

FD&C Act (21 U.S.C. 334), if its 

distribution continues. Shipment of 

devices in interstate commerce will be 

subject to injunction under section 302 

of the FD&C Act (21 U.S.C. 332), and the 

individuals responsible for such 

shipment will be subject to prosecution 

under section 303 of the FD&C Act (21 

U.S.C. 333). In the past, FDA has 

requested that manufacturers take action 

to prevent the further use of devices for 

which no PMA has been filed and may 

determine that such a request is 

appropriate for the class III device that 

is the subject of this regulation. 

The FD&C Act does not permit an 

extension of the 90-day period after 

issuance of a final rule within which an 

application or notice is required to be 

filed. The House Report on the 1976 

amendments states that ‘‘* * * [t]he 

thirty month ‘grace period’ afforded 

after classification of a device into class 

III * * * is sufficient time for 

manufacturers and importers to develop 

the data and conduct the investigations 

necessary to support an application of 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50665 

premarket approval’’ (H. Rept. 94–853, 

94th Cong., 2d sess. 42 (1976)). 

The SMDA added section 515(i) to the 

FD&C Act requiring FDA to review the 

classification of preamendments class III 

devices for which no final rule requiring 

the submission of PMAs has been 

issued, and to determine whether or not 

each device should be reclassified into 

class I or class II or remain in class III. 

For devices remaining in class III, the 

SMDA directed FDA to develop a 

schedule for issuing regulations to 

require premarket approval. The SMDA 

does not, however, prevent FDA from 

proceeding immediately to rulemaking 

under section 515(b) of the FD&C Act on 

specific devices, in the interest of public 

health, independent of the procedures 

of section 515(i). Proceeding directly to 

rulemaking under section 515(b) of the 

FD&C Act is consistent with Congress’ 

objective in enacting section 515(i), i.e., 

that preamendments class III devices for 

which PMAs have not been previously 

required either be reclassified to class I 

or class II or be subject to the 

requirements of premarket approval. 

In the Federal Register of May 6, 1994 

(59 FR 23731) (the May 6, 1994, notice), 

FDA issued a notice of availability of a 

preamendments class III devices 

strategy document. The strategy 

document set forth FDA’s plans for 

implementing the provisions of section 

515(i) of the FD&C Act for 

preamendments class III devices for 

which FDA had not yet required 

premarket approval. FDA divided this 

universe of devices into three groups as 

referenced in the May 6, 1994, notice. 

In the Federal Register of August 25, 

2010 (75 FR 52294) (the August 25, 

2010, proposed rule), FDA published a 

proposed rule to require the filing under 

section 515(b) of the FD&C Act of a 

PMA or notice of completion of a PDP 

for four premendments class III devices: 

Ventricular (bypass) assist device; 

pacemaker repair or replacement 

material; female condom; and 

transilluminator for breast evaluation. In 

accordance with section 515(b)(2)(A) of 

the FD&C Act, FDA included in the 

preamble of the proposal the Agency’s 

tentative findings with respect to the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the device to meet the 

premarket approval requirements of the 

FD&C Act, and the benefits to the public 

from use of the device. The August 25, 

2010, proposed rule also provided an 

opportunity for interested persons to 

submit comments on the proposed rule 

and the Agency’s findings. Under 

section 515(b)(2)(B) of the FD&C Act, 

FDA provided an opportunity for 

interested persons to request a change in 

the classification of the device based on 

new information relevant to its 

classification. Any petition requesting a 

change in classification of the devices 

was required to be submitted by 

September 9, 2010. The comment period 

closed November 23, 2010. 

FDA received no comments on the 

proposed rule. FDA received one 

petition requesting a change in the 

classification of the transilluminator for 

breast evaluation. FDA has yet to 

resolve the request; therefore, the 

transilluminator for breast evaluation is 

not subject to this final rule. 

II. Findings With Respect to Risks and 

Benefits 

Under section 515(b)(3) of the FD&C 

Act, FDA is adopting its findings as 

published in the August 25, 2010, 

proposed rule with the exception of the 

findings related to the transilluminator 

for breast evaluation. As required by 

section 515(b) of the FD&C Act, FDA 

published its findings regarding: (1) The 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring that these devices have an 

approved PMA or a declared completed 

PDP and (2) the benefits to the public 

from the use of the devices. 

These findings are based on the 

reports and recommendations of the 

advisory committees (panels) for the 

classification of these devices along 

with information submitted in response 

to the 515(i) Order, (74 FR 16214, April 

9, 2009), and any additional information 

that FDA has encountered. Additional 

information regarding the risks as well 

as classification associated with these 

device types can be found in the 

following proposed and final rules 

published in the Federal Register on 

these dates: Cardiovascular Devices— 

part 870 (21 CFR part 870) (44 FR 

13284, March 9, 1979 and 45 FR 7904, 

February 5, 1980, 52 FR 17732 at 17736, 

May 11, 1987); and Obstetrical and 

Gynecological Devices—part 884 (21 

CFR part 884) (64 FR 31164, June 10, 

1999, and 65 FR 31454, May 18, 2000). 

III. The Final Rule 

Under section 515(b)(3) of the FD&C 

Act, FDA is adopting its findings as 

published in the preamble to the 

proposed rule with the exception of the 

findings related to the transilluminator 

for breast evaluation. FDA is issuing this 

final rule to require premarket approval 

of these generic types of devices for 

class III preamendments devices by 

revising parts 870 and 884. 

Under the final rule, a PMA or a 

notice of completion of a PDP is 

required to be filed on or before 90 days 

after the date of publication of the final 

rule in the Federal Register, for any of 

these class III preamendments devices 

that were in commercial distribution 

before May 28, 1976, or that has been 

found by FDA to be substantially 

equivalent to such a device on or before 

90 days after the date of publication of 

the final rule in the Federal Register. 

An approved PMA or a declared 

completed PDP is required to be in 

effect for any such devices on or before 

180 days after FDA files the application. 

Any other class III preamendments 

device subject to this rule that was not 

in commercial distribution before May 

28, 1976, is required to have an 

approved PMA or a declared completed 

PDP in effect before it may be marketed. 

If a PMA or a notice of completion of 

a PDP for any of these class III 

preamendments devices is not filed on 

or before the 90th day past the effective 

date of this regulation, that device will 

be deemed adulterated under section 

501(f)(1)(A) of the FD&C Act, and 

commercial distribution of the device 

will be required to cease immediately. 

The device may, however, be 

distributed for investigational use, if the 

requirements of the IDE regulations 

(part 812) are met. 

IV. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) 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. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because there have been no 

premarket submissions for these devices 

in the past 5 years and all of the affected 

devices have fallen into disuse, FDA has 


jlentini on DSK4TPTVN1PROD with RULES
50666 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

concluded that there is little or no 

interest in marketing these devices in 

the future. Therefore, the Agency 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

FDA has concluded that this final rule 

will not have a significant impact. We 

base this determination on an analysis 

of registration and listing and other data 

for the affected devices. Two of the 

devices affected by this final rule, the 

female condom and ventricular bypass 

device, have never appeared in FDA’s 

electronic registration and listing 

database. These devices were identified 

as preamendment devices, but since 

their classification, the Agency has no 

record of them ever being marketed. In 

addition, these devices represent older 

technologies that have since been 

replaced by newer technologies 

currently being marketed under a PMA. 

The final affected device, pacemaker 

repair and replacement material, is a 

material that can be used in multiple 

devices that was last listed in 2001, and 

the Agency is aware of no evidence that 

the device has been marketed since 

1991. In addition, on the increasingly 

rare occasions when a pacemaker is 

repaired today, the repair is done with 

materials specific to the approved 

device. This information is summarized 

in table 1 of this document as follows. 

TABLE 1—SUMMARY OF ELECTRONIC REGISTRATION AND LISTING INFORMATION

Device name Product code 510(k) or 

PMA? Last listed Last marketed 

Replaced by 

approved 

technology? 

Female Condom ............................................ OBY ............ No ................ Never Listed .............. 1930s ......................... Yes. 

Ventricular Bypass Device ............................. OKR ............ No ............... Never Listed .............. No Record ................. Yes. 

Pacemaker Repair and Replacement ........... KFJ .............. No ................ 2001 .......................... 1991 .......................... Yes. 

Based on our review of electronic 

product registration and listing and 

other data, FDA concludes that there is 

currently little or no interest in 

marketing the affected devices and that 

the final rule will not have a significant 

economic impact. 

VI. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. Paperwork Reduction Act of 1995 

This final rule refers to currently 

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 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subpart B, have been approved 

under OMB control number 0910–0231; 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

List of Subjects in 21 CFR Parts 870 and 

884 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 870 

and 884 are amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 870.3545 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3545 Ventricular bypass (assist) 

device. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before November 

21, 2011, for any ventricular bypass 

(assist) device that was in commercial 

distribution before May 28, 1976, or that 

has, on or before November 21, 2011, 

been found to be substantially 

equivalent to any ventricular bypass 

(assist) device that was in commercial 

distribution before May 28, 1976. Any 

other ventricular bypass (assist) device 

shall have an approved PMA or 

declared completed PDP in effect before 

being placed in commercial 

distribution. 

■ 3. Section 870.3710 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3710 Pacemaker repair or 

replacement material. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before November 

21, 2011, for any pacemaker repair or 

replacement material device that was in 

commercial distribution before May 28, 

1976, or that has, on or before November 

21, 2011, been found to be substantially 

equivalent to any pacemaker repair or 

replacement material device that was in 

commercial distribution before May 28, 

1976. Any other pacemaker repair or 

replacement material device shall have 

an approved PMA or declared 

completed PDP in effect before being 

placed in commercial distribution. 


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PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

■ 4. The authority citation for 21 CFR 

part 884 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 5. Section 884.5330 is amended by 

revising paragraph (c) to read as follows: 

§ 884.5330 Female condom. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before November 

21, 2011, for any female condom that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

November 21, 2011, been found to be 

substantially equivalent to any female 

condom that was in commercial 

distribution before May 28, 1976. Any 

other female condom shall have an 

approved PMA or declared completed 

PDP in effect before being placed in 

commercial distribution. 

Dated: August 10, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20664 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0708] 

RIN 1625–AA11 

Regulated Navigation Area; 

Portsmouth Naval Shipyard, 

Portsmouth, NH 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a regulated navigation area 

on the Piscataqua River near 

Portsmouth, NH. This temporary final 

rule places speed restrictions on all 

vessels transiting the navigable waters 

on the Piscataqua River, Portsmouth, 

NH near the Portsmouth Naval Shipyard 

between Henderson Point Light on 

Seavey Island and Badgers Island Buoy 

14. This rule is necessary to provide for 

the safety of life on the navigable waters 

during ongoing ship construction. 

DATES: This rule is effective from 

August 16, 2011 until 5 p.m. on 

September 5, 2011. This rule will be 

enforced with actual notice from 7 a.m. 

on August 5, 2011 until 5 p.m. on 

September 5, 2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2011– 

0708 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2011–0708 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail Lieutenant Junior 

Grade Terence Leahy, Waterways 

Management Division at Coast Guard 

Sector Northern New England, 

telephone 207–767–0398, e-mail 

Terence.O.Leahy@uscg.mil or 

Lieutenant Junior Grade Isaac Slavitt, 

Waterways Management Division at 

Coast Guard First District, telephone 

617–223–8385. If you have questions on 

viewing the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

Coast Guard was not notified of the 

need for this rule until 13 July 2011, and 

the Portsmouth Naval Facility will begin 

diving operations in this area within a 

short timeframe making publication of a 

NPRM and Final Rule impractical. This 

regulated navigation area is necessary to 

provide for the safety of the divers and 

others working in the area as wake from 

passing vessels could cause the ship to 

move erratically and unexpectedly, 

injuring the divers and their support 

crews. Not providing for the safety of 

the divers and others in the area is 

contrary to the public interest of 

creating a safe work environment. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register as immediate action is 

necessary to provide for the safety of 

divers and workers on the vessel. In 

addition to the reasons stated within 

this preamble, a delay in the effective 

date of this rule is contrary to the 

public’s interest in ensuring the ship 

construction project continues as 

scheduled. 

Basis and Purpose 

Under the Ports and Waterways Safety 

Act, the Coast Guard has the authority 

to establish RNAs in defined water areas 

that are determined to have hazardous 

conditions and in which vessel traffic 

can be regulated in the interest of safety. 

See 33 U.S.C. 1231 and Department of 

Homeland Security Delegation No. 

0170.1. 

As part of ongoing ship construction 

projects at the Portsmouth Naval 

Shipyard, divers will be working on the 

hull of a vessel for approximately four 

weeks beginning on August 5, 2011. 

Unexpected and uncontrolled 

movement of the vessel due to wake 

while divers are in the water creates a 

significant risk of serious injury or 

death. In order to ensure the safety of 

vessel workers such as divers during the 

period of ship construction work, the 

Coast Guard is creating a regulated 

navigation area to limit the speed, and 

thus wake, of all vessels operating in the 

vicinity of the shipyard. 

Discussion of Rule 

This action places speed restrictions 

on all vessels transiting the navigable 

waters on the Piscataqua River, 

Portsmouth, NH near the Portsmouth 

Naval Shipyard between Henderson 

Point Light on Seavey Island and 

Badgers Island Buoy 14 when necessary 

for the safety of navigation during 

periods of ship construction work. All 

vessels operating in this area shall 

proceed with caution; operate at no 

more than 5 knots and in a manner so 

as to produce no wake. Diving 

operations and other vessel construction 

may occur at any time, day or night. 

The Captain of the Port Sector 

Northern New England will cause notice 

of enforcement or suspension of 

enforcement of this regulated navigation 

area to be made by all appropriate 

means in order to affect the widest 

distribution among the affected 

segments of the public. Such means of 

notification will include, but is not 

limited to, Broadcast Notice to Mariners 


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