81 FR 36924 - Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 110 (June 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 110 (June 8, 2016)
| Page Range | 36924-36928 | |
| FR Document | 2016-13522 |
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)] [Notices] [Pages 36924-36928] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13522] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0134] Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. DATES: Submit either electronic or written comments on the collection of information by August 8, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your [[Page 36925]] comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0134 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Mammography Quality Standards Act Requirements--21 CFR Part 900--OMB Control Number 0910-0309--Extension The Mammography Quality Standards Act (Pub. L. 102-539) requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. The intent of these regulations is to assure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance, and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer complaint mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis. The following sections of Title 21 of the Code of Federal Regulations (CFR) are not included in the burden tables because they are considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. Therefore, they resulted in no additional burden: 21 CFR 900.12(c)(1) and (3) and 900.3(f)(1). Section 900.24(c) was also not included in the burden tables because if a certifying State had its approval withdrawn, FDA would take over certifying authority for the affected facilities. Because FDA already has all the certifying State's electronic records, there wouldn't be an additional reporting burden. We have rounded numbers in the ``Total Hours'' column in all three burden tables. (Where the number was a portion of 1 hour, it has been rounded to 1 hour. All other ``Total Hours'' have been rounded to the nearest whole number.) We do not expect any respondents for Sec. 900.3(c) because all four ABs are approved until April 2020. [[Page 36926]] FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Total Average Total operating and Activity/21 CFR section/FDA form No. Number of responses per annual burden per Total capital maintenance respondents respondent responses response hours \1\ costs (in costs (in dollars) dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of intent to become an AB--900.3(b)(1).. 0.33 1 0.33 1 1 ........... .............. Application for approval as an AB; full \2\-- 0.33 1 0.33 320 106 10,000 .............. 900.3(b)(3)......................................... Application for approval as an AB; limited \3\-- 5 1 5 30 150 ........... .............. 900.3(b)(3)......................................... AB renewal of approval--900.3(c)..................... 0 1 0 15 1 ........... .............. AB application deficiencies--900.3(d)(2)............. 0.1 1 0.1 30 3 ........... .............. AB resubmission of denied applications--900.3(d)(5).. 0.1 1 0.1 30 3 ........... .............. Letter of intent to relinquish accreditation 0.1 1 0.1 1 1 ........... .............. authority--900.3(e)................................. Summary report describing all facility assessments-- 330 1 330 7 2,310 ........... 77,600 900.4(f)............................................ AB reporting to FDA; facility \4\--900.4(h).......... 8,654 1 8,654 1 8,654 ........... 4,327 AB reporting to FDA; AB \5\--900.4(h)................ 5 1 5 10 50 ........... .............. AB financial records--900.4(i)(2).................... 1 1 1 16 16 ........... .............. Former AB new application--900.6(c)(1)............... 0.1 1 0.1 60 6 ........... .............. Reconsideration of accreditation following appeal-- 1 1 1 2 2 ........... .............. 900.15(d)(3)(ii).................................... Application for alternative standard--900.18(c)...... 2 1 2 2 4 ........... .............. Alternative standard amendment--900.18(e)............ 10 1 10 1 10 ........... .............. Certification agency application--900.21(b).......... 0.33 1 0.33 320 106 ........... 208 Certification agency application deficiencies-- 0.1 1 0.1 30 3 ........... .............. 900.21(c)(2)........................................ Certification electronic data transmission--900.22(h) 5 200 1000 0.083 83 30,000 .............. Changes to standards--900.22(i)...................... 2 1 2 30 60 ........... 20 Certification agency minor deficiencies--900.24(b)... 1 1 1 30 30 ........... .............. Appeal of adverse action taken by FDA--900.25(a)..... 0.2 1 0.2 16 3 ........... .............. Inspection fee exemption--FDA Form 3422.............. 700 1 700 0.25 175 ........... .............. -------------------------------------------------------------------------------------------------- Total............................................ .............. .............. ........... ........... 11,777 40,000 82,155 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Total hours have been rounded. \2\ One time burden. \3\ Refers to accreditation bodies applying to accredit specific full-field digital mammography (FFDM) units. \4\ Refers to the facility component of the burden for this requirement. \5\ Refers to the AB component of the burden for this requirement. Table 2--Estimated Annual Recordkeeping Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Total Average burden Total operating and Activity/21 CFR section Number of records per annual per Total capital maintenance recordkeepers recordkeeper records recordkeeping hours \1\ costs (in costs (in dollars) dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- AB transfer of facility records--900.3(f)(1)...... 0.1 1 0.1 0 1 ........... .............. Consumer complaints system; AB--900.4(g).......... 5 1 5 1 5 ........... .............. Documentation of interpreting physician initial 87 1 87 8 696 ........... .............. requirements--900.12(a)(1)(i)(B)(2).............. Documentation of interpreting physician personnel 8,654 4 34,616 1 34,616 ........... .............. requirements--900.12(a)(4)....................... [[Page 36927]] Permanent medical record--900.12(c)(4)............ 8,654 1 8,654 1 8,654 28,000 .............. Procedures for cleaning equipment--900.12(e)(13).. 8,654 52 450,008 0.083 37,351 ........... .............. Audit program--900.12(f).......................... 8,654 1 8,654 16 138,464 ........... .............. Consumer complaints system; facility--900.12(h)(2) 8,654 2 17,308 1 17,308 ........... .............. Certification agency conflict of interest-- 5 1 5 1 5 ........... .............. 900.22(a)........................................ Processes for suspension and revocation of 5 1 5 1 5 ........... .............. certificates--900.22(d).......................... Processes for appeals--900.22(e).................. 5 1 5 1 5 ........... .............. Processes for additional mammography review-- 5 1 5 1 5 ........... .............. 900.22(f)........................................ Processes for patient notifications--900.22(g).... 3 1 3 1 3 ........... 30 Evaluation of certification agency--900.23........ 5 1 5 20 100 ........... .............. Appeals--900.25(b)................................ 5 1 5 1 5 ........... .............. ----------------------------------------------------------------------------------------------------- Total......................................... .............. .............. ........... .............. 237,223 28,000 30 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Total hours have been rounded. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of operating and Activity/21 CFR section Number of disclosures Total annual Average burden Total hours maintenance respondents per respondent disclosures per disclosure \2\ costs (in dollars) -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of facilities that AB relinquishes its 0.1 1 0.1 200 20 50 accreditation--900.3(f)(2)............................. Clinical images; facility \3\--900.4(c), 900.11(b)(1) 2,885 1 2,885 1.44 4,154 .............. and (2)................................................ Clinical images; AB \4\--900.4(c)....................... 5 1 5 416 2,080 230,773 Phantom images; facility \3\--900.4(d), 900.11(b)(1) and 2,885 1 2,885 0.72 2,077 .............. (2).................................................... Phantom images; AB \4\--900.4(d)........................ 5 1 5 208 1,040 .............. Annual equipment evaluation and survey; facility \3\-- 8,654 1 8,654 1 8,654 8,654 900.4(e), 900.11(b)(1) and (2)......................... Annual equipment evaluation and survey; AB \4\--900.4(e) 5 1 5 1,730 8,650 .............. Provisional mammography facility certificate extension 0 1 0 0.5 1 .............. application--900.11(b)(3).............................. Mammography facility certificate reinstatement 312 1 312 5 1,560 24,000,000 application--900.11(c)................................. Lay summary of examination--900.12(c)(2)................ 8,654 5,085 44,055,590 0.083 3,652,464 .............. Lay summary of examination; patient refusal \5\-- 87 1 87 0.5 44 .............. 900.12(c)(2)........................................... Report of unresolved serious complaints--900.12(h)(4)... 20 1 20 1 20 .............. Information regarding compromised quality; facility \3\-- 20 1 20 200 4,000 300 900.12(j)(1)........................................... Information regarding compromised quality; AB \4\-- 20 1 20 320 6,400 600 900.12(j)(1)........................................... Patient notification of serious risk--900.12(j)(2)...... 5 1 5 100 500 19,375 Reconsideration of accreditation--900.15(c)............. 5 1 5 2 10 .............. [[Page 36928]] Notification of requirement to correct major 0.4 1 0.4 200 80 68 deficiencies--900.24(a)................................ Notification of loss of approval; major deficiencies-- 0.15 1 0.15 100 15 25.50 900.24(a)(2)........................................... Notification of probationary status--900.24(b)(1)....... 0.3 1 0.3 200 60 51 Notification of loss of approval; minor deficiencies-- 0.15 1 0.15 100 15 25.50 900.24(b)(3)........................................... ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. 3,691,842 24,259,921 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. \2\ Total hours have been rounded. \3\ Refers to the facility component of the burden for this requirement. \4\ Refers to the AB component of the burden for this requirement. \5\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. Dated: June 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13522 Filed 6-7-16; 8:45 am] BILLING CODE 4164-01-P
![36924 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
At least one portion of the meeting will Procedure: On July 26, 2016, from 1 Dated: June 2, 2016.
be closed to the public. p.m. to 3:30 p.m., the meeting is open Jill Hartzler Warner,
DATES: The meeting will be held on July to the public. Interested persons may Associate Commissioner for Special Medical
26, 2016, from 1 p.m. to 3:30 p.m. present data, information, or views, Programs.
ADDRESSES: FDA White Oak Campus, orally or in writing, on issues pending [FR Doc. 2016–13457 Filed 6–7–16; 8:45 am]
10903 New Hampshire Ave., Building before the committee. Written BILLING CODE 4164–01–P
31 Conference Center, the Great Room submissions may be made to the contact
(Rm. 1503), Silver Spring, MD 20993– person on or before July 12, 2016. Oral
0002. Answers to commonly asked presentations from the public will be DEPARTMENT OF HEALTH AND
questions including information scheduled between approximately 1:30 HUMAN SERVICES
regarding special accommodations due p.m. and 2:30 p.m. Those individuals
to a disability, visitor parking, and Food and Drug Administration
interested in making formal oral
transportation may be accessed at: presentations should notify the contact [Docket No. FDA–2013–N–0134]
http://www.fda.gov/Advisory person and submit a brief statement of
Committees/AboutAdvisoryCommittees/ Agency Information Collection
the general nature of the evidence or Activities; Proposed Collection;
ucm408555.htm.
arguments they wish to present, the Comment Request; Mammography
FOR FURTHER INFORMATION CONTACT: names and addresses of proposed Quality Standards Act Requirements
Janie Kim or Denise Royster, Center for participants, and an indication of the
Biologics Evaluation and Research, approximate time requested to make AGENCY: Food and Drug Administration,
Food and Drug Administration, 10903 their presentation on or before July 1, HHS.
New Hampshire Ave., Bldg. 71, Silver 2016. Time allotted for each ACTION: Notice.
Spring, MD 20993–0002, 301–796–9016
presentation may be limited. If the SUMMARY: The Food and Drug
or 240–402–8158, email: Janie.Kim@
number of registrants requesting to Administration (FDA) is announcing an
fda.hhs.gov or Denise.Royster@
fda.hhs.gov, or FDA Advisory speak is greater than can be reasonably opportunity for public comment on the
Committee Information Line, 1–800– accommodated during the scheduled proposed collection of certain
741–8138 (301–443–0572 in the open public hearing session, FDA may information by the Agency. Under the
Washington, DC area). A notice in the conduct a lottery to determine the Paperwork Reduction Act of 1995 (the
Federal Register about last-minute speakers for the scheduled open public PRA), Federal Agencies are required to
modifications that impact a previously hearing session. The contact person will publish notice in the Federal Register
announced advisory committee meeting notify interested persons regarding their concerning each proposed collection of
cannot always be published quickly request to speak by July 5, 2016. information, including each proposed
enough to provide timely notice. Closed Committee Deliberations: On extension of an existing collection of
Therefore, you should always check the July 26, 2016, from 2:30 p.m. to 3:30 information, and to allow 60 days for
Agency’s Web site at http://www.fda. p.m., the meeting will be closed to public comment in response to the
gov/AdvisoryCommittees/default.htm permit discussion where disclosure notice. This notice solicits comments on
and scroll down to the appropriate the estimated reporting, recordkeeping,
would constitute a clearly unwarranted
advisory committee meeting link, or call and third-party disclosure burden
invasion of personal privacy (5 U.S.C.
the advisory committee information line associated with the Mammography
552b(c)(6)). The committee will discuss
to learn about possible modifications Quality Standards Act requirements.
before coming to the meeting. reports of intramural research programs
DATES: Submit either electronic or
and make recommendations regarding
SUPPLEMENTARY INFORMATION: written comments on the collection of
Agenda: On July 26, 2016, the personnel staffing decisions.
information by August 8, 2016.
committee will meet by teleconference. Persons attending FDA’s advisory ADDRESSES: You may submit comments
In open session, the committee will hear committee meetings are advised that the as follows:
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Laboratory of Molecular Oncology, FDA welcomes the attendance of the Submit electronic comments in the
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meetings and will make every effort to
Biotechnology Products, Center for Drug www.regulations.gov. Follow the
accommodate persons with disabilities. instructions for submitting comments.
Evaluation and Research, FDA.
FDA intends to make background If you require accommodations due to a Comments submitted electronically,
material available to the public no later disability, please contact Janie Kim at including attachments, to http://
than 2 business days before the meeting. least 7 days in advance of the meeting. www.regulations.gov will be posted to
If FDA is unable to post the background FDA is committed to the orderly the docket unchanged. Because your
material on its Web site prior to the conduct of its advisory committee comment will be made public, you are
meeting, the background material will meetings. Please visit our Web site at solely responsible for ensuring that your
be made publicly available at the http://www.fda.gov/Advisory comment does not include any
location of the advisory committee Committees/AboutAdvisoryCommittees/ confidential information that you or a
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mstockstill on DSK3G9T082PROD with NOTICES
ucm111462.htm for procedures on
will be posted on FDA’s Web site after public conduct during advisory such as medical information, your or
the meeting. Background material is committee meetings. anyone else’s Social Security number, or
available at http://www.fda.gov/ confidential business information, such
AdvisoryCommittees/Calendar/ Notice of this meeting is given under as a manufacturing process. Please note
default.htm. Scroll down to the the Federal Advisory Committee Act (5 that if you include your name, contact
appropriate advisory committee meeting U.S.C. app. 2). information, or other information that
link. identifies you in the body of your
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![36928 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Total
Number of operating
Total Average
Activity/21 CFR Number disclosures Total and
annual burden per
section of respondents per hours 2 maintenance
disclosures disclosure
respondent costs
(in dollars)
Notification of requirement to correct
major deficiencies—900.24(a) .............. 0.4 1 0.4 200 80 68
Notification of loss of approval; major de-
ficiencies—900.24(a)(2) ....................... 0.15 1 0.15 100 15 25.50
Notification of probationary status—
900.24(b)(1) .......................................... 0.3 1 0.3 200 60 51
Notification of loss of approval; minor de-
ficiencies—900.24(b)(3) ....................... 0.15 1 0.15 100 15 25.50
Total .................................................. ........................ ........................ ........................ ........................ 3,691,842 24,259,921
1 There are no capital costs associated with this collection of information.
2 Total hours have been rounded.
3 Refers to the facility component of the burden for this requirement.
4 Refers to the AB component of the burden for this requirement.
5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
Dated: June 2, 2016. December 5, 2016. See ‘‘Petitions’’ in and Drug Administration, 5630 Fishers
Leslie Kux, the SUPPLEMENTARY INFORMATION section Lane, Rm. 1061, Rockville, MD 20852.
Associate Commissioner for Policy. for more information. • For written/paper comments
[FR Doc. 2016–13522 Filed 6–7–16; 8:45 am] ADDRESSES: You may submit comments submitted to the Division of Dockets
BILLING CODE 4164–01–P as follows: Management, FDA will post your
comment, as well as any attachments,
Electronic Submissions except for information submitted,
DEPARTMENT OF HEALTH AND Submit electronic comments in the marked and identified, as confidential,
HUMAN SERVICES following way: if submitted as detailed in
‘‘Instructions.’’
Food and Drug Administration • Federal eRulemaking Portal: http:// Instructions: All submissions received
www.regulations.gov. Follow the must include the Docket Nos. FDA–
[Docket Nos. FDA–2014–E–2351, FDA– instructions for submitting comments. 2014–E–2351, FDA–2014–E–2352, and
2014–E–2352, and FDA–2014–E–2350] Comments submitted electronically, FDA–2014–E–2350 for ‘‘Determination
including attachments, to http:// of Regulatory Review Period for
Determination of Regulatory Review www.regulations.gov will be posted to
Period for Purposes of Patent Purposes of Patent Extension;
the docket unchanged. Because your ALPROLIX.’’
Extension; ALPROLIX comment will be made public, you are Received comments will be placed in
AGENCY: Food and Drug Administration, solely responsible for ensuring that your the docket and, except for those
HHS. comment does not include any submitted as ‘‘Confidential
confidential information that you or a Submissions,’’ publicly viewable at
ACTION: Notice.
third party may not wish to be posted, http://www.regulations.gov or at the
SUMMARY: The Food and Drug such as medical information, your or Division of Dockets Management
Administration (FDA) has determined anyone else’s Social Security number, or between 9 a.m. and 4 p.m., Monday
the regulatory review period for confidential business information, such through Friday.
ALPROLIX and is publishing this notice as a manufacturing process. Please note • Confidential Submissions—To
of that determination as required by that if you include your name, contact submit a comment with confidential
law. FDA has made the determination information, or other information that information that you do not wish to be
because of the submission of identifies you in the body of your made publicly available, submit your
applications to the Director of the U.S. comments, that information will be comments only as a written/paper
Patent and Trademark Office (USPTO), posted on http://www.regulations.gov. submission. You should submit two
Department of Commerce, for the • If you want to submit a comment copies total. One copy will include the
extension of patents which claim that with confidential information that you information you claim to be confidential
human biological product. do not wish to be made available to the with a heading or cover note that states
DATES: Anyone with knowledge that any public, submit the comment as a ‘‘THIS DOCUMENT CONTAINS
of the dates as published (see the written/paper submission and in the CONFIDENTIAL INFORMATION.’’ The
SUPPLEMENTARY INFORMATION section) are manner detailed (see ‘‘Written/Paper Agency will review this copy, including
incorrect may submit either electronic Submissions’’ and ‘‘Instructions’’). the claimed confidential information, in
mstockstill on DSK3G9T082PROD with NOTICES
or written comments and ask for a Written/Paper Submissions its consideration of comments. The
redetermination by August 8, 2016. second copy, which will have the
Furthermore, any interested person may Submit written/paper submissions as claimed confidential information
petition FDA for a determination follows: redacted/blacked out, will be available
regarding whether the applicant for • Mail/Hand delivery/Courier (for for public viewing and posted on http://
extension acted with due diligence written/paper submissions): Division of www.regulations.gov. Submit both
during the regulatory review period by Dockets Management (HFA–305), Food copies to the Division of Dockets
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Document Created: 2016-06-08 03:10:49
Document Modified: 2016-06-08 03:10:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by August 8, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 36924 |
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