81 FR 29273 - Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 91 (May 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 91 (May 11, 2016)
| Page Range | 29273-29275 | |
| FR Document | 2016-11114 |
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)] [Notices] [Pages 29273-29275] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11114] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0450] Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications 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 information collection provisions of abbreviated new animal drug applications. DATES: Submit either electronic or written comments on the collection of information by July 11, 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 [[Page 29274]] 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-2013-N-0450] for ``Abbreviated New Animal Drug 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, [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. Abbreviated New Animal Drug Applications--Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1)) (OMB Control Number 0910-0669))--Extension Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), any person may file an abbreviated new animal drug application (ANADA) seeking approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an ANADA is described in section 512(n)(1) of the FD&C Act. Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We use the information submitted, among other things, to assess bioequivalence to the originally approved drug and thus, the safety and effectiveness of the generic new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. Applicants may submit Form FDA 356v with a complete ANADA or a phased review submission to ensure efficient and accurate processing of information. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of FD&C Act sections 512 (b)(2) and (n)(1) FDA Form Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- ANADA................................................... 356v 18 1 18 159 2,862 [[Page 29275]] Phased Review with Administrative ANADA................. 356v 3 5 15 31.8 477 --------------- Total............................................... .............. .............. .............. .............. .............. 3,339 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimates on our experience with ANADA submissions and requests for phased review. We estimate that we will receive 21 ANADA submissions per year over the next three years and that three of those submissions will request phased review. We estimate that each applicant that uses the phased review process will have approximately five phased reviews per application. We estimate that an applicant will take approximately 159 hours to prepare either an ANADA or the estimated 5 ANADA phased review submissions and the administrative ANADA. Dated: May 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-11114 Filed 5-10-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices 29273
The regulations in § 170.39 (21 CFR food additives for use in food-contact data that will enable FDA to estimate
170.39) established a process that articles where the resulting dietary the daily dietary concentration resulting
provides the manufacturer with an exposure is 1 percent or less of the from the proposed use of the substance;
opportunity to demonstrate that the acceptable daily intake for these (5) results of a literature search for
likelihood or extent of migration to food substances. toxicological data on the substance and
of a substance used in a food-contact In order to determine whether the its impurities; and (6) information on
article is so trivial that the use need not intended use of a substance in a food- the environmental impact that would
be the subject of a food additive listing contact article meets the threshold result from the proposed use.
criteria, certain information specified in
regulation or an effective notification. FDA uses this information to
§ 170.39(c) must be submitted to FDA.
The Agency has established two determine whether the food-contact
This information includes the following
thresholds for the regulation of components: (1) The chemical article meets the threshold criteria.
substances used in food-contact articles. composition of the substance for which Respondents to this information
The first exempts those substances used the request is made; (2) detailed collection are individual manufacturers
in food-contact articles where the information on the conditions of use of and suppliers of substances used in
resulting dietary concentration would the substance; (3) a clear statement of food-contact articles (i.e., food
be at or below 0.5 part per billion (ppb). the basis for the request for exemption packaging and food processing
The second exempts regulated direct from regulation as a food additive; (4) equipment) or of the articles themselves.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR 170.39 responses per burden per Total hours
respondents responses
respondent response
Threshold of regulation for substances used in food-con-
tact articles ....................................................................... 7 1 7 48 336
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, we list of exempted substances which is on SUMMARY: The Food and Drug
consulted our records of the number of display at FDA’s Division of Dockets Administration (FDA) is announcing an
regulation exemption requests received Management and on the Internet at opportunity for public comment on the
in the past three years. The annual http://www.fda.gov/Food/ proposed collection of certain
hours per response reporting estimate of IngredientsPackagingLabeling/ information by the Agency. Under the
48 hours is based on information PackagingFCS/ Paperwork Reduction Act of 1995 (the
received from representatives of the ThresholdRegulationExemptions/ PRA), Federal Agencies are required to
food packaging and processing ucm093685.htm. Having the list of publish notice in the Federal Register
industries and Agency records. exempted substances publicly available concerning each proposed collection of
We estimate that approximately 7 decreases the likelihood that a company information, including each proposed
requests per year will be submitted would submit a food additive petition or extension of an existing collection of
under the threshold of regulation a notification for the same type of food- information, and to allow 60 days for
exemption process of § 170.39, for a contact application of a substance for public comment in response to the
total of 336 hours. The threshold of which the Agency has previously notice. This notice solicits comments on
regulation process offers one advantage granted an exemption from the food the information collection provisions of
over the premarket notification process additive listing regulation requirement. abbreviated new animal drug
for food-contact substances established Dated: May 5, 2016. applications.
by section 409(h) of FD&C Act (OMB Leslie Kux, DATES: Submit either electronic or
control number 0910–0495) in that the Associate Commissioner for Policy. written comments on the collection of
use of a substance exempted by FDA is [FR Doc. 2016–11083 Filed 5–10–16; 8:45 am] information by July 11, 2016.
not limited to only the manufacturer or BILLING CODE 4164–01–P ADDRESSES: You may submit comments
supplier who submitted the request for as follows:
an exemption. Other manufacturers or
suppliers may use exempted substances Electronic Submissions
DEPARTMENT OF HEALTH AND
in food-contact articles as long as the HUMAN SERVICES Submit electronic comments in the
conditions of use (e.g., use levels, following way:
temperature, type of food contacted, Food and Drug Administration • Federal eRulemaking Portal: http://
etc.) are those for which the exemption www.regulations.gov. Follow the
was issued. As a result, the overall [Docket No. FDA–2013–N–0450] instructions for submitting comments.
burden on both Agency and the Comments submitted electronically,
regulated industry would be Agency Information Collection including attachments, to http://
significantly less in that other www.regulations.gov will be posted to
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Activities; Proposed Collection;
manufacturers and suppliers would not Comment Request; Abbreviated New the docket unchanged. Because your
have to prepare, and we would not have Animal Drug Applications comment will be made public, you are
to review, similar submissions for solely responsible for ensuring that your
identical components of food-contact AGENCY: Food and Drug Administration, comment does not include any
articles used under identical conditions. HHS. confidential information that you or a
Manufacturers and other interested third party may not wish to be posted,
ACTION: Notice.
persons can easily access an up-to-date such as medical information, your or
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![29274 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices
anyone else’s Social Security number, or for public viewing and posted on http:// of the proposed collection of
confidential business information, such www.regulations.gov. Submit both information set forth in this document.
as a manufacturing process. Please note copies to the Division of Dockets With respect to the following
that if you include your name, contact Management. If you do not wish your collection of information, FDA invites
information, or other information that name and contact information to be comments on these topics: (1) Whether
identifies you in the body of your made publicly available, you can the proposed collection of information
comments, that information will be provide this information on the cover is necessary for the proper performance
posted on http://www.regulations.gov. sheet and not in the body of your
of FDA’s functions, including whether
• If you want to submit a comment comments and you must identify this
the information will have practical
with confidential information that you information as ‘‘confidential.’’ Any
do not wish to be made available to the utility; (2) the accuracy of FDA’s
information marked as ‘‘confidential’’
public, submit the comment as a estimate of the burden of the proposed
will not be disclosed except in
written/paper submission and in the collection of information, including the
accordance with 21 CFR 10.20 and other
manner detailed (see ‘‘Written/Paper applicable disclosure law. For more validity of the methodology and
Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of assumptions used; (3) ways to enhance
comments to public dockets, see 80 FR the quality, utility, and clarity of the
Written/Paper Submissions information to be collected; and (4)
56469, September 18, 2015, or access
Submit written/paper submissions as the information at: http://www.fda.gov/ ways to minimize the burden of the
follows: regulatoryinformation/dockets/ collection of information on
• Mail/Hand delivery/Courier (for default.htm. respondents, including through the use
written/paper submissions): Division of Docket: For access to the docket to of automated collection techniques,
Dockets Management (HFA–305), Food read background documents or the when appropriate, and other forms of
and Drug Administration, 5630 Fishers electronic and written/paper comments information technology.
Lane, Rm. 1061, Rockville, MD 20852. received, go to http://
• For written/paper comments Abbreviated New Animal Drug
www.regulations.gov and insert the Applications—Sections 512(b)(2) and
submitted to the Division of Dockets docket number, found in brackets in the
Management, FDA will post your (n)(1) of the Federal Food, Drug, and
heading of this document, into the Cosmetic Act (21 U.S.C. 360b(b)(2) and
comment, as well as any attachments, ‘‘Search’’ box and follow the prompts
except for information submitted, (n)(1)) (OMB Control Number 0910–
and/or go to the Division of Dockets 0669))—Extension
marked and identified, as confidential, Management, 5630 Fishers Lane, Rm.
if submitted as detailed in 1061, Rockville, MD 20852. Under section 512(b)(2) of the Federal
‘‘Instructions.’’
Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: FDA Food, Drug, and Cosmetic Act (the
must include the Docket No. [FDA– PRA Staff, Office of Operations, Food FD&C Act), any person may file an
2013–N–0450] for ‘‘Abbreviated New and Drug Administration, 8455 abbreviated new animal drug
Animal Drug Applications.’’ Received Colesville Rd., COLE–14526, Silver application (ANADA) seeking approval
comments will be placed in the docket Spring, MD 20993–0002, PRAStaff@ of a generic copy of an approved new
and, except for those submitted as fda.hhs.gov. animal drug. The information required
‘‘Confidential Submissions,’’ publicly SUPPLEMENTARY INFORMATION: Under the to be submitted as part of an ANADA is
viewable at http://www.regulations.gov PRA (44 U.S.C. 3501–3520), Federal described in section 512(n)(1) of the
or at the Division of Dockets Agencies must obtain approval from the FD&C Act. Among other things, an
Management between 9 a.m. and 4 p.m., Office of Management and Budget ANADA is required to contain
Monday through Friday. (OMB) for each collection of information to show that the proposed
• Confidential Submissions—To information they conduct or sponsor. generic drug is bioequivalent to, and has
submit a comment with confidential ‘‘Collection of information’’ is defined the same labeling as, the approved new
information that you do not wish to be in 44 U.S.C. 3502(3) and 5 CFR animal drug. We use the information
made publicly available, submit your 1320.3(c) and includes Agency requests submitted, among other things, to assess
comments only as a written/paper or requirements that members of the bioequivalence to the originally
submission. You should submit two public submit reports, keep records, or approved drug and thus, the safety and
copies total. One copy will include the provide information to a third party. effectiveness of the generic new animal
information you claim to be confidential Section 3506(c)(2)(A) of the PRA (44 drug. We allow applicants to submit a
with a heading or cover note that states U.S.C. 3506(c)(2)(A)) requires Federal complete ANADA or to submit
‘‘THIS DOCUMENT CONTAINS Agencies to provide a 60-day notice in information in support of an ANADA
CONFIDENTIAL INFORMATION.’’ The the Federal Register concerning each for phased review. Applicants may
Agency will review this copy, including proposed collection of information, submit Form FDA 356v with a complete
the claimed confidential information, in including each proposed extension of an ANADA or a phased review submission
its consideration of comments. The existing collection of information, to ensure efficient and accurate
second copy, which will have the before submitting the collection to OMB processing of information.
claimed confidential information for approval. To comply with this FDA estimates the burden of this
redacted/blacked out, will be available requirement, FDA is publishing notice collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
mstockstill on DSK3G9T082PROD with NOTICES
Number of Average
Number of Total annual
FD&C Act sections 512 (b)(2) and (n)(1) FDA Form responses per burden per Total hours
respondents responses
respondent response
ANADA ..................................................... 356v 18 1 18 159 2,862
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![Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices 29275
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
FD&C Act sections 512 (b)(2) and (n)(1) FDA Form responses per burden per Total hours
respondents responses
respondent response
Phased Review with Administrative
ANADA ................................................. 356v 3 5 15 31.8 477
Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,339
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our features such a user-fee program should identifies you in the body of your
experience with ANADA submissions include. comments, that information will be
and requests for phased review. We DATES: The public meeting will be held posted on http://www.regulations.gov.
estimate that we will receive 21 ANADA on Friday, June 10, 2016, from 9 a.m. to • If you want to submit a comment
submissions per year over the next three 5 p.m. EDT. However, depending on the with confidential information that you
years and that three of those level of public participation, the do not wish to be made available to the
submissions will request phased review. meeting may be extended or may end public submit the comment as a written/
We estimate that each applicant that early. paper submission and in the manner
uses the phased review process will detailed (see ‘‘Written/Paper
ADDRESSES: The public meeting will be
have approximately five phased reviews Submissions’’ and ‘‘Instructions’’).
held at FDA’s White Oak Campus, Bldg.
per application. We estimate that an 31 Conference Center, 10903 New Written/Paper Submissions
applicant will take approximately 159 Hampshire Ave., the Great Room (Rm.
hours to prepare either an ANADA or Submit written/paper submissions as
1503A), Silver Spring, MD 20993–0002. follows:
the estimated 5 ANADA phased review Entrance for the public meeting • Mail/Hand delivery/Courier (for
submissions and the administrative participants (non-FDA employees) is written/paper submissions): Division of
ANADA. through Building 1, where routine Dockets Management (HFA–305), Food
Dated: May 5, 2016. security check procedures will be and Drug Administration, 5630 Fishers
Leslie Kux, performed. For parking and security Lane, Rm. 1061, Rockville, MD 20852.
Associate Commissioner for Policy. information refer to http://www.fda.gov/ • For written/paper comments
[FR Doc. 2016–11114 Filed 5–10–16; 8:45 am] aboutfda/workingatfda/ submitted to the Division of Dockets
BILLING CODE 4164–01–P buildingsandfacilities/ Management, FDA will post your
whiteoakcampusinformation/ comment, as well as any attachments,
ucm241740.htm. except for information submitted,
DEPARTMENT OF HEALTH AND Comments: Regardless of marked and identified, as confidential,
HUMAN SERVICES participation at the public meeting, if submitted as detailed in
interested persons may submit ‘‘Instructions.’’
Food and Drug Administration electronic or written comments Instructions: All submissions received
regarding this document. To provide must include the Docket No. FDA–
[Docket No. FDA–2016–N–1092] adequate time for parties to submit 2016–N–1092 for ‘‘Over-the-Counter
comments before and after the public Monograph User Fees: Public Meeting;
Over-the-Counter Monograph User meeting, the docket will remain open 30 Requests for Comments.’’ Received
Fees: Public Meeting; Request for days after the public meeting. comments will be placed in the docket
Comments You may submit comments as and, except for those submitted as
follows: ‘‘Confidential Submissions,’’ publicly
AGENCY: Food and Drug Administration, viewable at http://www.regulations.gov
HHS. Electronic Submissions or at the Division of Dockets
ACTION: Notice of public meeting; Submit electronic comments in the Management between 9 a.m. and 4 p.m.,
request for comments. following way: Monday through Friday.
• Federal eRulemaking Portal: http:// • Confidential Submissions—To
SUMMARY: The Food and Drug www.regulations.gov. Follow the submit a comment with confidential
Administration (FDA) is announcing a instructions for submitting comments. information that you do not wish to be
public meeting to gather stakeholder Comments submitted electronically, made publicly available submit your
input on the potential development of a including attachments, to http:// comments only as a written/paper
user-fee program for nonprescription www.regulations.gov will be posted to submission. You should submit two
(over-the-counter or OTC) monograph the docket unchanged. Because your copies total. One copy will include the
drugs. A user-fee program would comment will be made public, you are information you claim to be confidential
provide funding to supplement solely responsible for ensuring that your with a heading or cover note that states
congressional non-user-fee comment does not include any ‘‘THIS DOCUMENT CONTAINS
appropriations, and would support confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
mstockstill on DSK3G9T082PROD with NOTICES
timely and efficient FDA review of the third party may not wish to be posted, Agency will review this copy, including
efficacy and safety of ingredients such as medical information, your or the claimed confidential information, in
included in or proposed for inclusion in anyone else’s Social Security number, or its consideration of comments. The
a monograph. FDA invites public confidential business information, such second copy, which will have the
comment on a potential OTC as a manufacturing process. Please note claimed confidential information
monograph user-fee program and also that if you include your name, contact redacted/blacked out, will be available
invites suggestions regarding the information, or other information that for public viewing and posted on http://
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Document Created: 2016-05-11 01:11:43
Document Modified: 2016-05-11 01:11:43
| 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 July 11, 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 29273 |
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