Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 68199 

frequency of performance drills 

regarding operation of exits in the 

normal and emergency modes on that 

type aircraft. 

(D) The substitute pilot or flight 

engineer is in possession of all items 

required for duty. 

(E) The substitute pilot or flight 

engineer is located in the passenger 

cabin. 

(F) The substitute pilot or flight 

engineer is identified to the passengers. 

(G) The substitution of a pilot or flight 

engineer for a required flight attendant 

does not interfere with the safe 

operation of the flight. 

(H) The airplane engines are shut 

down. 

(I) At least one floor-level exit remains 

open to provide for passenger egress. 

(b) During passenger deplaning, on 

each airplane for which more than one 

flight attendant is required by § 121.391, 

the certificate holder may reduce the 

number of flight attendants required by 

that paragraph provided: 

(1) The airplane engines are shut 

down; 

(2) At least one floor level exit 

remains open to provide for passenger 

egress; and 

(3) The number of flight attendants on 

board is at least half the number 

required by § 121.391, rounded down to 

the next lower number in the case of 

fractions, but never fewer than one. 

(c) If only one flight attendant is on 

the airplane during passenger boarding 

or deplaning, that flight attendant must 

be located in accordance with the 

certificate holder’s FAA-approved 

operating procedures. If more than one 

flight attendant is on the airplane during 

passenger boarding or deplaning, the 

flight attendants must be evenly 

distributed throughout the airplane 

cabin, in the vicinity of the floor-level 

exits, to provide the most effective 

assistance in the event of an emergency. 

(d) The time spent by any 

crewmember conducting passenger 

boarding or deplaning duties is 

considered duty time. 

Issued in Washington, DC, on October 28, 

2010. 

J. Randolph Babbitt, 

Administrator, Federal Aviation 

Administration. 

[FR Doc. 2010–28056 Filed 11–4–10; 8:45 am] 

BILLING CODE 4910–03–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

15 CFR Part 902 

50 CFR Part 665 

[Docket No. 0907211157–0522–04] 

RIN 0648–AX76 

Fisheries in the Western Pacific; 

Community Development Program 

Process 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule; effectiveness of 

collection-of-information requirements. 

SUMMARY: In this rule, NMFS announces 

approval by the Office of Management 

and Budget (OMB) of collection-ofinformation requirements contained in 

regulations implementing Amendment 1 

to the Fishery Ecosystem Plans for 

American Samoa, Hawaii, the Mariana 

Archipelago, and Western Pacific 

Pelagic Fisheries, relating to the 

community development plan process. 

The intent of this final rule is to inform 

the public that OMB has approved the 

associated reporting requirements. 

DATES: New 50 CFR 665.20(c), 

published at 75 FR 54044 (September 3, 

2010), has been approved by OMB and 

is effective on December 6, 2010. The 

amendment to 15 CFR part 902 in this 

rule is effective December 6, 2010. 

ADDRESSES: Written comments 

regarding the burden-hour estimates or 

other aspects of the collection-ofinformation requirements contained in 

this final rule may be submitted to 

NMFS, attention Michael D. Tosatto, 

1601 Kapiolani Blvd., Honolulu, HI 

96814, and to OMB by e-mail to 

OIRA_Submission@omb.eop.gov or fax 

to 202–395–7285. 

FOR FURTHER INFORMATION CONTACT: 

Jarad Makaiau, NMFS Pacific Islands 

Region (PIR), Sustainable Fisheries, tel 

808–944–2108. 

SUPPLEMENTARY INFORMATION: A final 

rule for Amendment 1 was published in 

the Federal Register on September 3, 

2010 (75 FR 54044). The requirements 

of that final rule, other than the 

collection-of-information requirements, 

were effective on October 4, 2010. 

Because OMB had not approved the 

collection-of-information requirements 

by the date that final rule was 

published, the effective date of the 

associated permitting and reporting 

requirements in that rule was delayed. 

OMB approved the collection-ofinformation requirements contained in 

the final rule on September 22, 2010. 

Under NOAA Administrative Order 

205–11, dated December 17, 1990, the 

Under Secretary for Oceans and 

Atmosphere has delegated authority to 

sign material for publication in the 

Federal Register to the Assistant 

Administrator for Fisheries, NOAA. 

Classification 

This final rule has been determined to 

be not significant for purposes of 

Executive Order 12866. 

Notwithstanding any other provision 

of the law, no person is required to 

respond to, and no person shall be 

subject to penalty for failure to comply 

with, a collection of information subject 

to the requirements of the Paperwork 

Reduction Act (PRA), unless that 

collection of information displays a 

currently valid OMB control number. 

This final rule contains new 

collection-of-information requirements 

subject to the PRA under OMB Control 

Number 0648–0612. The public 

reporting burden for developing and 

submitting a development plan is 

estimated to average six hours per 

response, including the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing the collection 

information. Send comments regarding 

these burden estimates or any other 

aspect of this data collection, including 

suggestions for reducing the burden, to 

NMFS (see ADDRESSES) and to OMB by 

e-mail to 

OIRA_Submission@omb.eop.gov or fax 

to 202–395–7285. 

List of Subjects in 15 CFR Part 902 

Reporting and recordkeeping 

requirements. 

Dated: November 2, 2010. 

Samuel D. Rauch III, 

Deputy Assistant Administrator for 

Regulatory Programs, National Marine 

Fisheries Service. 

■ For the reasons set out in the 

preamble, 15 CFR part 902 is amended 

as follows: 

PART 902—NOAA INFORMATION 

COLLECTION REQUIREMENTS UNDER 

THE PAPERWORK REDUCTION ACT: 

OMB CONTROL NUMBERS 

■ 1. The authority citation for part 902 

continues to read as follows: 

Authority: 44 U.S.C. 3501 et seq. 

■ 2. In § 902.1, amend the table in 

paragraph (b), under the entry ‘‘50 CFR’’ 

mstockstill on DSKH9S0YB1PROD with RULES

68200 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations 

by adding the entry for § 665.20 in 

numerical order to read as follows: 

§ 902.1 OMB control numbers assigned 

pursuant to the Paperwork Reduction Act. 

* * * * * 

(b) * * * 

CFR part or section where the information collection requirement is located Current OMB control No. 

(all numbers begin with 0648–) 

*******

50 CFR ............................................................................................................................................................ ............................................................

* * * * * * * 

665.20 .............................................................................................................................................................. –0612 

*******

[FR Doc. 2010–28075 Filed 11–4–10; 8:45 am] 

BILLING CODE 3510–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 892 

[Docket No. FDA–2008–N–0273] 

Medical Devices; Radiology Devices; 

Reclassification of Full-Field Digital 

Mammography System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

reclassification of the full-field digital 

mammography (FFDM) system from 

class III (premarket approval) to class II 

(special controls). The device type is 

intended to produce planar digital x-ray 

images of the entire breast; this generic 

type of device may include digital 

mammography acquisition software, 

full-field digital image receptor, 

acquisition workstation, automatic 

exposure control, image processing and 

reconstruction programs, patient and 

equipment supports, component parts, 

and accessories. The special control that 

will apply to the device is the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: FullField Digital Mammography System.’’ 

FDA is reclassifying the device into 

class II (special controls) because 

general controls along with special 

controls will provide a reasonable 

assurance of safety and effectiveness of 

the device. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of the 

guidance document that will serve as 

the special control for this device. 

DATES: This rule is effective December 6, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Mary Pastel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. G304, 

Silver Spring, MD 20993–0002, 301– 

796–6887; or 

Kyle J. Myers, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 62, rm. 3118, 

Silver Spring, MD 20993–0002, 301– 

796–2533. 

SUPPLEMENTARY INFORMATION: 

I. Statutory Framework for Device 

Classification 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 301 et 

seq.), as amended by the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

the Safe Medical Devices Act of 1990 

(Pub. L. 101–629), the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115), 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, 

FDA refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as ‘‘preamendments 

devices.’’ FDA classifies these devices 

after the Agency has taken the following 

steps: 

1. Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); 

2. Publishes the panel’s 

recommendation for comment, along 

with a proposed regulation classifying 

the device; and 

3. Publishes a final regulation 

classifying the device type. 

FDA has classified most 

preamendments devices under these 

procedures. 

FDA refers to devices that were not in 

commercial distribution before May 28, 

1976, as ‘‘postamendments devices.’’ 

These devices are classified 

automatically by statute (section 513(f) 

of the FD&C Act) into class III without 

any FDA rulemaking process. These 

device types remain in class III and 

require premarket approval, unless and 

until: 

1. FDA reclassifies the device type 

into class I or II; 

2. FDA issues an order classifying the 

device type into class I or II in 

accordance with section 513(f)(2) of the 

FD&C Act, as amended by FDAMA; or 

3. FDA issues an order finding the 

device to be substantially equivalent, 

under 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 of the regulations. 

Reclassification of classified 

postamendments devices is governed by 

section 513(f)(3) of the FD&C Act. This 

section provides that FDA may initiate 

the reclassification of a device classified 

into class III under section 513(f)(1) of 

the FD&C Act, or the manufacturer or 

importer of a device may petition the 

Secretary of Health and Human Services 

(the Secretary) for the issuance of an 

order classifying the device into class I 

or class II. FDA’s regulations in 21 CFR 

860.134 set forth the procedures for the 

filing and review of a petition for 

reclassification of these class III devices. 

To change the classification of the 

device, the proposed new class must 

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