52300 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 

final rule in the Federal Register], for 

any pacemaker repair or replacement 

material device that was in commercial 

distribution before May 28, 1976, or that 

has, on or before [date 90 days after date 

of publication of the final rule in the 

Federal Register], 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. 

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 FDA on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], for 

any female condom that was in 

commercial distribution before May 28, 

1976, or that has, on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], 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. 

PART 892—RADIOLOGY DEVICES 

6. The authority citation for 21 CFR 

part 892 continues to read as follows: 

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

360j, 371. 

7. Section 892.1990 is amended by 

revising paragraph (c) to read as follows: 

§ 892.1990 Transilluminator for breast 

evaluation. 

* * * * * 

(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 FDA on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], for 

any transilluminator for breast 

evaluation that was in commercial 

distribution before May 28, 1976, or that 

has, on or before [date 90 days after date 

of publication of the final rule in the 

Federal Register], been found to be 

substantially equivalent to any 

transilluminator for breast evaluation 

that was in commercial distribution 

before May 28, 1976. Any other 

transilluminator for breast evaluation 

shall have an approved PMA or 

declared completed PDP in effect before 

being placed in commercial 

distribution. 

Dated: August 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21142 Filed 8–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 253 

[Docket No. 0908061221–91225–01] 

RIN 0648–AY16 

Merchant Marine Act and MagnusonStevens Fishery Conservation and 

Management Act Provisions; Fishing 

Vessel, Fishing Facility and Individual 

Fishing Quota Lending Program 

Regulations; Correction 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule, correction and 

reopening of comment period. 

SUMMARY: NMFS published a proposed 

rule on May 5, 2010, amending the 

Fisheries Finance Program’s 

programmatic regulations. The proposed 

rule was published with an incorrect 

Regulatory Identification Number (RIN) 

in the ADDRESSES section. Members of 

the public using the incorrect RIN may 

have had difficulty posting comments at 

http://www.regulations.gov. In order to 

allow anyone adversely affected by the 

mistake to submit comments, NMFS 

reopens the comment period and 

requests additional comments for two 

weeks. 

DATES: NMFS invites the public to 

comment on the proposed rule 

published at 75 FR 24549. Comments 

must be submitted in writing on or 

before September 8, 2010. 

ADDRESSES: You may submit comments 

on the proposed rule, identified by RIN 

0648–AY16 by any one of the following 

methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal eRulemaking Portal at http:// 

www.regulations.gov. 

• Fax: (301) 713–1306, Attn: Earl 

Bennett. 

• Mail: Earl Bennett, Acting Chief, 

Financial Services Division, NMFS, 

Attn: F/MB5, 1315 East-West Highway, 

SSMC3, Silver Spring, MD 20910. 

Instructions: All comments received 

are a part of the public record and will 

generally be posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit Confidential Business 

Information or otherwise sensitive or 

protected information. 

NMFS will accept anonymous 

comments (enter N/A in the required 

fields if you wish to remain 

anonymous). Attachments to electronic 

comments will be accepted in Microsoft 

Word, Excel, WordPerfect, or Adobe 

PDF file formats only. Written 

comments regarding the burden-hour 

estimates or other aspects of the 

collection-of-information requirements 

contained in this proposed rule may be 

submitted to earl.bennett@noaa.gov or 

david.rostker@omb.eop.gov or faxed to 

(202) 395–7285. 

FOR FURTHER INFORMATION CONTACT: Earl 

Bennett, (301) 713–2390 x 187, 

earl.bennett@noaa.gov. 

SUPPLEMENTARY INFORMATION: 

Need for Correction 

On May 5, 2010, NMFS published a 

proposed rule at 75 FR 24549, which 

can be viewed at http:// 

www.fakr.noaa.gov/prules/ 

75fr24549.pdf. 

The ADDRESSES section of the 

proposed rule contained an incorrect 

RIN. Although members of the public 

submitting comments by mail, fax and 

e-mail to the addresses listed in the 

proposed rule would have been 

unaffected, those attempting to post 

comments at http://www.regulations.gov 

may have been hindered from posting 

comments because of this error. In order 

to allow anyone adversely affected by 

the mistake the opportunity to 

comment, NMFS will take comments for 

an additional two weeks. 

The new sentence in the ADDRESSES

section of column one in 75 FR 24550 

should read: ‘‘You may submit 

comments, identified by 0648–AY16, by 

any one of the following methods:’’ 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 52301 

Dated: August 20, 2010. 

Samuel D. Rauch III, 

Deputy Assistant Administrator for 

Regulatory Programs, National Marine 

Fisheries Service. 

[FR Doc. 2010–21135 Filed 8–24–10; 8:45 am] 

BILLING CODE 3510–22–P 


srobinson on DSKHWCL6B1PROD with PROPOSALS