81_FR_4939 81 FR 4921 - Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

81 FR 4921 - Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range4921-4923
FR Document2016-01684

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 procedure by which an applicant may obtain an assignment or designation determination for combination products.

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016) 
[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4921-4923]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Product Jurisdiction: Assignment of Agency Component 
for Review of Premarket Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 procedure by which an 
applicant may obtain an assignment or designation determination for 
combination products.

DATES: Submit either electronic or written comments on the collection 
of information by March 28, 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

[[Page 4922]]

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 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-2009-N-0380 for ``Product Jurisdiction: Assignment of Agency 
Component for Review of Premarket Applications.'' 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, PRAStaff@fda.hhs.gov.

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.
Product Jurisdiction: Assignment of Agency Component for Review of 
Premarket Applications 21 CFR Part 3 (OMB Control Number 0910-0523)--
Extension
    This regulation relates to Agency management and organization and 
has two purposes. The first is to implement section 503(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by 
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by 
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), by specifying how FDA will determine the organizational component 
within FDA assigned to have primary jurisdiction for the premarket 
review and regulation of products that are comprised of any combination 
of: (1) A drug and a device; (2) a device and a biological product; (3) 
a biological product and a drug; or (4) a drug, a device, and a 
biological product. The second purpose of this regulation is to enhance 
the efficiency of Agency management and operations by providing 
procedures for classifying and determining which Agency component is 
designated to have primary jurisdiction for any drug, device, or 
biological product where such jurisdiction is unclear or in dispute.
    The regulation establishes a procedure by which an applicant may 
obtain an assignment or designation determination. The regulation 
requires that the request include the identity of the applicant, a 
comprehensive description of the product and its proposed use, and the 
applicant's recommendation as to which Agency component should have 
primary jurisdiction, with an accompanying statement of reasons. The 
information submitted would be used by FDA as the basis for making the 
assignment or designation decision. Most information required by the 
regulation is already required for premarket applications affecting 
drugs, devices, biological products, and combination products. The 
respondents will be businesses or other for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 4923]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Numberr of
                            21 CFR Part                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3                                                                                84                1               84               24            2,016
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These burden estimates are based on the number of applications FDA 
received over the past fiscal year.

    Dated: January 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01684 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4921 TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued First year Number of Hours per 21 CFR Section frequency of Total records Total hours recordkeepers record recordkeeping 7. Controls to Prevent Adulteration by Equipment or Uten- sils 106.30(d)(1) and 106.100(f)(2) .................................. 3 52 156 0.21 32.76 8. Controls to Prevent Adulteration by Equipment or Uten- sils 106.30(e)(3)(iii) and 106.100(f)(3) ............................. 3 52 156 0.21 32.76 9. Controls to Prevent Adulteration by Equipment or Uten- sils 106.30(f)(2) and 106.100(f)(4) ................................... 3 52 156 0.19 29.64 10. Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5) ..................................................................... 3 52 3 520 1,560 11. Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5) ..................................................................... 12 2 6 640 3,840 12. Controls to Prevent Adulteration Caused by Ingredi- ents, Containers, and Closures 106.40(g) and 106.100(f)(6) ..................................................................... 3 52 156 0.17 26.52 13. Controls to Prevent Adulteration During Manufacturing 106.50 and 106.100(e) ..................................................... 3 52 156 0.23 35.88 14. Controls to Prevent Adulteration From Microorganisms 106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7) ................ 3 52 156 0.25 39 15. Controls to Prevent Adulteration During Packaging and Labeling of Infant Formula 106.60(c) ............................... 1 12 12 0.25 3 16. General Quality Control-Testing 106.91(b)(1) through (3) ..................................................................................... 2 1 2 2 4 17. General Quality Control 106.91(b)(1) and (d), and 106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 18. General Quality Control 106.91(b)(2) and (d), and 106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 19. General Quality Control 106.91(b)(3) and (d), and 106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 20. Audit Plans and Procedures 106.94—Ongoing Review and Updating of Audits ..................................................... 3 1 3 8 24 21. Audit Plans and Procedures 106.94—Regular Audits .. 3 52 156 4 624 Total Recurring Recordkeeping Burden ....................... ........................ ........................ ........................ ........................ 6,328.06 Total Recordkeeping Burden ........................................ ........................ ........................ ........................ ........................ 25,648.06 1 As noted previously, the burden for making and maintaining such records is expected to occur once every 4 years. The total hours column reflects the total number of hours averaged over the 4 year period. 2 As noted previously, the burden for making and maintaining such records is expected to occur once every four years. The total hours column reflects the total number of hours averaged over the four-year period. III. Reference DEPARTMENT OF HEALTH AND information including each proposed HUMAN SERVICES extension of an existing collection of The following reference has been information and to allow 60 days for placed on display in the Division of Food and Drug Administration public comment in response to the Dockets Management (HFA–305), Food notice. This notice solicits comments on [Docket No. FDA–2009–N–0380] and Drug Administration, 5630 Fishers the procedure by which an applicant Lane, Rm. 1061, Rockville, MD 20852, Agency Information Collection may obtain an assignment or and may be seen by interested persons Activities; Proposed Collection; designation determination for between 9 a.m. and 4 p.m., Monday Comment Request; Product combination products. through Friday. Jurisdiction: Assignment of Agency DATES: Submit either electronic or 1. Zink, Don. Statement of Donald L. Zink: Component for Review of Premarket written comments on the collection of Infant Formula Manufacturing Practices, Applications information by March 28, 2016. 2013. ADDRESSES: You may submit comments AGENCY: Food and Drug Administration, Dated: January 22, 2016. HHS. as follows: Leslie Kux, ACTION: Notice. Electronic Submissions Associate Commissioner for Policy. SUMMARY: The Food and Drug Submit electronic comments in the [FR Doc. 2016–01690 Filed 1–27–16; 8:45 am] Administration (FDA) is announcing an following way: wgreen on DSK2VPTVN1PROD with NOTICES BILLING CODE 4164–01–P opportunity for public comment on the • Federal eRulemaking Portal: http:// proposed collection of certain www.regulations.gov. Follow the information by the Agency. Under the instructions for submitting comments. Paperwork Reduction Act of 1995 (the Comments submitted electronically, PRA), Federal Agencies are required to including attachments, to http:// publish notice in the Federal Register www.regulations.gov will be posted to concerning each proposed collection of the docket unchanged. Because your VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\28JAN1.SGM 28JAN1

4922 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices comment will be made public, you are http://www.regulations.gov. Submit estimate of the burden of the proposed solely responsible for ensuring that your both copies to the Division of Dockets collection of information, including the comment does not include any Management. If you do not wish your validity of the methodology and confidential information that you or a name and contact information to be assumptions used; (3) ways to enhance third party may not wish to be posted, made publicly available, you can the quality, utility, and clarity of the such as medical information, your or provide this information on the cover information to be collected; and (4) anyone else’s Social Security number, or sheet and not in the body of your ways to minimize the burden of the confidential business information, such comments and you must identify this collection of information on as a manufacturing process. Please note information as ‘‘confidential.’’ Any respondents, including through the use that if you include your name, contact information marked as ‘‘confidential’’ of automated collection techniques, information, or other information that will not be disclosed except in when appropriate, and other forms of identifies you in the body of your accordance with 21 CFR 10.20 and other information technology. comments, that information will be applicable disclosure law. For more Product Jurisdiction: Assignment of posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment Agency Component for Review of comments to public dockets, see 80 FR Premarket Applications 21 CFR Part 3 with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the (OMB Control Number 0910–0523)— the information at: http://www.fda.gov/ Extension public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. This regulation relates to Agency manner detailed (see ‘‘Written/Paper Docket: For access to the docket to management and organization and has Submissions’’ and ‘‘Instructions’’). read background documents or the two purposes. The first is to implement electronic and written/paper comments section 503(g) of the Federal Food, Drug, Written/Paper Submissions and Cosmetic Act (21 U.S.C. 353(g)), as received, go to http:// Submit written/paper submissions as www.regulations.gov and insert the added by the Safe Medical Devices Act follows: docket number, found in brackets in the of 1990 (Pub. L. 101–629), and amended • Mail/Hand delivery/Courier (for heading of this document, into the by the Medical Device User Fee and written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Modernization Act of 2002 (Pub. L. 107– Dockets Management (HFA–305), Food and/or go to the Division of Dockets 250), by specifying how FDA will and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. determine the organizational component Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. within FDA assigned to have primary • For written/paper comments jurisdiction for the premarket review FOR FURTHER INFORMATION CONTACT: FDA submitted to the Division of Dockets and regulation of products that are Management, FDA will post your PRA Staff, Office of Operations, Food comprised of any combination of: (1) A comment, as well as any attachments, and Drug Administration, 8455 drug and a device; (2) a device and a except for information submitted, Colesville Rd., COLE–14526, Silver biological product; (3) a biological marked and identified, as confidential, Spring, MD 20993–0002, PRAStaff@ product and a drug; or (4) a drug, a if submitted as detailed in fda.hhs.gov. device, and a biological product. The ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the second purpose of this regulation is to Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal enhance the efficiency of Agency must include the Docket No. FDA– Agencies must obtain approval from the management and operations by 2009–N–0380 for ‘‘Product Jurisdiction: Office of Management and Budget providing procedures for classifying and Assignment of Agency Component for (OMB) for each collection of determining which Agency component Review of Premarket Applications.’’ information they conduct or sponsor. is designated to have primary Received comments will be placed in ‘‘Collection of information’’ is defined jurisdiction for any drug, device, or the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR biological product where such submitted as ‘‘Confidential 1320.3(c) and includes Agency requests jurisdiction is unclear or in dispute. Submissions,’’ publicly viewable at or requirements that members of the The regulation establishes a http://www.regulations.gov or at the public submit reports, keep records, or procedure by which an applicant may Division of Dockets Management provide information to a third party. obtain an assignment or designation between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44 determination. The regulation requires through Friday. U.S.C. 3506(c)(2)(A)) requires Federal that the request include the identity of • Confidential Submissions—To Agencies to provide a 60-day notice in the applicant, a comprehensive submit a comment with confidential the Federal Register concerning each description of the product and its information that you do not wish to be proposed collection of information proposed use, and the applicant’s made publicly available, submit your including each proposed extension of an recommendation as to which Agency comments only as a written/paper existing collection of information, component should have primary submission. You should submit two before submitting the collection to OMB jurisdiction, with an accompanying copies total. One copy will include the for approval. To comply with this statement of reasons. The information information you claim to be confidential requirement, FDA is publishing notice submitted would be used by FDA as the with a heading or cover note that states of the proposed collection of basis for making the assignment or ‘‘THIS DOCUMENT CONTAINS information set forth in this document. designation decision. Most information CONFIDENTIAL INFORMATION.’’ The With respect to the following required by the regulation is already wgreen on DSK2VPTVN1PROD with NOTICES Agency will review this copy, including collection of information, FDA invites required for premarket applications the claimed confidential information, in comments on these topics: (1) Whether affecting drugs, devices, biological its consideration of comments. The the proposed collection of information products, and combination products. second copy, which will have the is necessary for the proper performance The respondents will be businesses or claimed confidential information of FDA’s functions, including whether other for-profit organizations. redacted/blacked out, will be available the information will have practical FDA estimates the burden of this for public viewing and posted on utility; (2) the accuracy of FDA’s collection of information as follows: VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\28JAN1.SGM 28JAN1

Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4923 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Numberr of Average Number of Total annual 21 CFR Part responses per burden per Total hours respondents responses respondent response 3 84 1 84 24 2,016 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These burden estimates are based on www.regulations.gov will be posted to made publicly available, submit your the number of applications FDA the docket unchanged. Because your comments only as a written/paper received over the past fiscal year. comment will be made public, you are submission. You should submit two Dated: January 25, 2016. solely responsible for ensuring that your copies total. One copy will include the Leslie Kux, comment does not include any information you claim to be confidential Associate Commissioner for Policy. confidential information that you or a with a heading or cover note that states third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS [FR Doc. 2016–01684 Filed 1–27–16; 8:45 am] such as medical information, your or CONFIDENTIAL INFORMATION’’. The BILLING CODE 4164–01–P anyone else’s Social Security number, or Agency will review this copy, including confidential business information, such the claimed confidential information, in DEPARTMENT OF HEALTH AND as a manufacturing process. Please note its consideration of comments. The HUMAN SERVICES that if you include your name, contact second copy, which will have the information, or other information that claimed confidential information Food and Drug Administration identifies you in the body of your redacted/blacked out, will be available comments, that information will be for public viewing and posted on [Docket No. FDA–2013–N–0297] posted on http://www.regulations.gov. http://www.regulations.gov. Submit • If you want to submit a comment both copies to the Division of Dockets Agency Information Collection with confidential information that you Management. If you do not wish your Activities; Proposed Collection; do not wish to be made available to the name and contact information to be Comment Request; Prevention of public, submit the comment as a made publicly available, you can Salmonella Enteritidis in Shell Eggs written/paper submission and in the provide this information on the cover During Production; Recordkeeping and manner detailed (see ‘‘Written/Paper sheet and not in the body of your Registration Provisions Submissions’’ and ‘‘Instructions’’). comments and you must identify this AGENCY: Food and Drug Administration, information as ‘‘confidential.’’ Any Written/Paper Submissions HHS. information marked as ‘‘confidential’’ ACTION: Notice. Submit written/paper submissions as will not be disclosed except in follows: accordance with 21 CFR 10.20 and other SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for applicable disclosure law. For more Administration (FDA or we) is written/paper submissions): Division of information about FDA’s posting of announcing an opportunity for public Dockets Management (HFA–305), Food comments to public dockets, see 80 FR comment on the proposed collection of and Drug Administration, 5630 Fishers 56469, September 18, 2015, or access certain information by the Agency. Lane, Rm. 1061, Rockville, MD 20852. the information at: http://www.fda.gov/ Under the Paperwork Reduction Act of • For written/paper comments regulatoryinformation/dockets/ 1995 (the PRA), Federal Agencies are submitted to the Division of Dockets default.htm. required to publish notice in the Management, FDA will post your Docket: For access to the docket to Federal Register concerning each comment, as well as any attachments, read background documents or the proposed collection of information, except for information submitted, electronic and written/paper comments including each proposed extension of an marked and identified, as confidential, received, go to http:// existing collection of information, and if submitted as detailed in www.regulations.gov and insert the to allow 60 days for public comment in ‘‘Instructions.’’ docket number, found in brackets in the response to the notice. This notice Instructions: All submissions received heading of this document, into the solicits comments on the information must include the Docket No. FDA– ‘‘Search’’ box and follow the prompts collection provisions of FDA’s 2013–N–0297 for Agency Information and/or go to the Division of Dockets recordkeeping and registration Collection Activities; Proposed Management, 5630 Fishers Lane, Rm. requirements for shell egg producers. Collection; Comment Request; 1061, Rockville, MD 20852. DATES: Submit either electronic or Prevention of Salmonella Enteritidis in FOR FURTHER INFORMATION CONTACT: FDA written comments on the collection of Shell Eggs During Production— PRA Staff, Office of Operations, Food information by March 28, 2016. Recordkeeping and Registration and Drug Administration, 8455 ADDRESSES: You may submit comments Provisions. Received comments will be Colesville Rd., COLE–14526, Silver as follows: placed in the docket and, except for Spring, MD 20993–0002, those submitted as ‘‘Confidential Electronic Submissions PRAStaff@fda.hhs.gov. Submissions,’’ publicly viewable at wgreen on DSK2VPTVN1PROD with NOTICES Submit electronic comments in the http://www.regulations.gov or at the SUPPLEMENTARY INFORMATION: Under the following way: Division of Dockets Management PRA (44 U.S.C. 3501–3520), Federal • Federal eRulemaking Portal: http:// between 9 a.m. and 4 p.m., Monday Agencies must obtain approval from the www.regulations.gov. Follow the through Friday. Office of Management and Budget instructions for submitting comments. • Confidential Submissions—To (OMB) for each collection of Comments submitted electronically, submit a comment with confidential information they conduct or sponsor. including attachments, to http:// information that you do not wish to be ‘‘Collection of information’’ is defined VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\FR\FM\28JAN1.SGM 28JAN1


Document Created: 2018-02-02 12:41:04
Document Modified: 2018-02-02 12:41:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by March 28, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 4921 
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